An Open-label, Dose Escalation Trial to Evaluate the Safe... | NCT03779113 | Trialant
NCT03779113
Sponsor
Hutchmed
Status
Terminated
Last Update Posted
Feb 18, 2026Actual
Enrollment
69Actual
Phase
Phase 1
Conditions
Non Hodgkin Lymphoma
Interventions
HMPL-523
Countries
United States
Denmark
Finland
France
Italy
Poland
Spain
Protocol Section
Identification Module
NCT ID
NCT03779113
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
2018-523-00US1
Secondary IDs
Not provided
Brief Title
An Open-label, Dose Escalation Trial to Evaluate the Safety and Pharmacokinetics of HMPL-523 in Patients With Lymphoma
Official Title
A Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Patients With Relapsed or Refractory Lymphoma
Acronym
Not provided
Organization
HutchmedINDUSTRY
Status Module
Record Verification Date
Jan 2026
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Study terminated by sponsor
Expanded Access Info
No
Start Date
Sep 26, 2019Actual
Primary Completion Date
Feb 26, 2025Actual
Completion Date
Feb 26, 2025Actual
First Submitted Date
Dec 10, 2018
First Submission Date that Met QC Criteria
Dec 14, 2018
First Posted Date
Dec 19, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Dec 17, 2025
Results First Submitted that Met QC Criteria
Jan 30, 2026
Results First Posted Date
Feb 18, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 30, 2026
Last Update Posted Date
Feb 18, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
HutchmedINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a Phase I, open-label, multicenter study of HMPL-523 administered orally to patients with relapsed or refractory lymphoma who have exhausted approved therapy options. This study consists of a dose escalation stage (Stage1) and a dose expansion stage (Stage 2).
Detailed Description
This is a Phase I, open-label, multicenter study of HMPL-523 administered orally to patients with relapsed or refractory lymphoma who have exhausted approved therapy options. This study consists of a dose escalation stage (Stage1) and a dose expansion stage (Stage 2).
Dose Escalation Stage (Stage 1)
Dosing will begin at 100 mg once daily (QD). A cycle of study treatment will be defined as 28 days of continuous dosing. The modified 3+3 design will be applied for dose escalation and MTD determination to limit the number of patients exposed to potentially ineffective or unsafe doses. The study will enroll 1 patient and the patient will be treated for a 28-day cycle in the initial dose cohort. If there is no Dose Limiting Toxicity (DLT) and no more than 2 treatment-emergent adverse events (TEAEs) of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 in the first treatment cycle, the study will be escalated to the next dose cohort and continue with the standard 3+3 design. Otherwise, the trial will revert to a standard 3+3 design from the initial dose cohort. A minimum of 3 patients will be enrolled and observed for toxicity in each successive dose cohort after the initial dose cohort. If the 3 patients initially enrolled in a given dose cohort complete the DLT assessment window (Cycle 1, Days 1-28) without experiencing a DLT, 3 patients will be enrolled at the next higher dose level. If 2 or more of the initial 3 patients enrolled at any dose level experience a DLT during the DLT assessment window, the dose escalation will be halted. If 1 of the initial 3 patients enrolled at any dose level experiences a DLT during the DLT assessment window, additional patients will be enrolled at that dose level for a minimum of 6 evaluable patients for DLT. If a DLT is observed in 1 of the 6 valuable patients at this dose level, dose escalation will proceed to the next pre- defined dose level. If DLTs are observed in 2 or more of the 6 evaluable patients at a given dose level, the dose escalation will be halted. If the dose escalation is completed due to 2 or more DLTs at a dose level and that dose level is ≥50% higher than the previous dose level, then an intermediate dose level may be evaluated for toxicity in the same manner as described above. If the dose level is <50% higher than the previous dose level, in which only 3 DLT evaluable patients were enrolled, 3 additional patients will be enrolled at that dose level to comprise 6 DLT evaluable patients.
The proposed dose escalation scheme comprises Cohorts 1 to 5 with dosing levels of 100 mg QD, 200 mg QD, 400 mg QD, 600 mg QD and 800 mg QD, respectively. The need for dose escalation beyond 800 mg QD, the specific dose to be tested and the potential for twice-daily (BID) dosing will be evaluated jointly by investigators and the sponsor based on the cumulative clinical safety, pharmacokinetic, and preliminary efficacy data. Safety monitoring and evaluation of dose escalation will be carried out by the Safety Review Committee, which will be comprised of the sponsor's study team members (including medical monitor, safety monitor and and Pharmacokinetic scientist) and the site principal investigators. The adverse event profile and serum concentration of HMPL-523 data will be evaluated to determine whether it is safe to continue the assigned HMPL-523 dose for dose escalation or whether the dose should be de-escalated to the lower dose level.
Dose Expansion Stage (Stage 2)
The adverse event profile, serum concentration, and preliminary anti-tumor activity of HMPL-523 at the maximum tolerated dose(MTD)/recommended phase 2 dose(RP2D) will be further evaluated in approximately 50 patients with relapsed or refractory indolent B-cell non-Hodgkin's lymphomas. The tumor types of the dose expansion stage are restricted to:
10 patients with chronic lymphocytic leukemia/small lymphocytic lymphoma
20 patients with chronic lymphocytic leukemia/small lymphocytic lymphoma post-BTK exposure
10 patients with mantle cell lymphoma
20 patients with follicular lymphoma (Grade 1-3a)
10 patients with marginal zone lymphoma
10 patients with waldenström's macroglobulinemia/lymphoplasmacytic lymphoma
10 patients with peripheral T- cell lymphoma
10 patients with cutaneous B-cell lymphoma
10 patients with hodgkin lymphoma
Patients will receive HMPL-523 at the MTD/RP2D for continuous 28-day treatment cycles until disease progression, death, intolerable toxicity, at investigator's discretion that the patient can no longer benefit from the study treatment, patient withdrawal from the study, or the end of study, whichever comes first.
Conditions Module
Conditions
Non Hodgkin Lymphoma
Keywords
lymphoma
chronic lymphocytic leukemia
Hodgkin lymphoma
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
69Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Treatment
Experimental
All patients to received study drug (HMPL-523)
Drug: HMPL-523
Interventions
Name
Type
Description
Arm Group Labels
Other Names
HMPL-523
Drug
Oral HMPL-523
Treatment
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Dose Escalation Stage: Number of Patients With Dose-Limiting Toxicities (DLTs)
A DLT was defined as the occurrence of any of the following treatment-emergent adverse events (TEAEs) during the DLT assessment window, unless clearly unrelated to the study treatment. AEs were graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0: non-hematologic toxicity: all non-hematologic TEAEs of Grade 3 or greater with the exception of Grade 3 nausea or vomiting controlled by supportive therapy; hematologic toxicity: Grade 4 neutropenia >5 days, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or which required platelets transfusion, Grade >=3 febrile neutropenia (defined as absolute neutrophil count <1000/cubic millimeter with a single temperature >38.3 degree Celsius [°C] or a sustained temperature of >=38°C for more than 1 hour), Grade 4 anemia not explained by underlying disease; any TEAE that required a dose delay of >=15 days; any case of Hy's Law.
From the first dose of study treatment (Day 1) up to Day 28 of Cycle 1 (each cycle was 28 days)
Dose Escalation Stage: Number of Patients With Treatment-Emergent Adverse Events, Treatment Related Treatment-Emergent Adverse Events, Treatment-Emergent Adverse Events Leading to Treatment Interruption, Treatment Reduction and Treatment Discontinuation
An AE was any untoward medical occurrence in a clinical study patient temporally associated with the use of a study treatment, whether or not considered related to the treatment. TEAEs were defined as AEs with an onset date on or after the first dose of study treatment and no later than 30 days after the date of last study treatment administration or start of a new treatment of anti-neoplasm therapy, whichever was earlier. Treatment related AEs were the TEAEs that were reported as related to study treatment by the Investigator.
From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months
Dose Escalation Stage: Recommended Phase 2 Dose of HMPL-523
RP2D was based on the pharmacokinetics (PK), safety, and tolerability assessments in dose escalation stage patients.
Secondary Outcomes
Measure
Description
Time Frame
Dose Escalation Stage and Dose Expansion Stage: Maximum Plasma Concentration (Cmax) of HMPL-523
Blood samples were collected to determine Cmax of HMPL-523. The PK parameters were determined by non-compartmental analysis. Eventually, the patients discontinued as they progressed in the study. Hence, fewer patients at each cycle and no patients returned on Cycle 1 Day 28 in dose expansion stage: MZL arm.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patients must meet the following criteria to be eligible for study entry:
Signed informed consent form (ICF).
Age ≥18 years.
ECOG performance status of 0 or 1.
Histologically confirmed lymphoma, including Hodgkin's lymphoma and non-Hodgkin's lymphoma. In the dose expansion stage, the tumor types may be restricted to any or all of the following tumor types. There may be approximately 10 patients in each cohort depending on response signals suggesting efficacy, except for 2 identified cohorts with approximately 20 patients per cohort: relapsed or refractory CLL/SLL, CLL/SLL post-BTK exposure (n=20), MCL, FL (Grade 1-3a) (n=20), MZL, WM/LPL, PTCL,CBCL, and/or HL
Patients with relapsed or refractory lymphoma who have exhausted all approved therapy options.
In the dose expansion stage, patients must have measurable disease for an objective response assessment, except for patients with CLL and WM/LPL
Availability of tumor sample for patients in dose expansion cohorts: This may be an archival tissue sample obtained after most recent therapy or a fresh biopsy; if tumor sample is not available, the Sponsor may waive the requirement after discussion
Expected survival of more than 24 weeks as determined by the investigator.
Male patients must agree to use a condom and female patients of childbearing potential must agree to use highly effective contraceptive measures for 30 days after the last dose of study drug. These include as combined hormonal contraception associated with inhibition of ovulation (oral, intravaginal, and transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, and implantable), intrauterine contraceptive device, intrauterine hormone release system, bilateral tubal occlusion, or a vasectomized partner, provided that male partner is the sole sexual partner of the female patient. Postmenopausal females (women who have not had menses for at least 1 year without an alternative medical cause) are exempt from this criterion.
Exclusion Criteria
Patients with primary central nervous system (CNS) lymphoma.
Any of the following laboratory abnormalities: Absolute neutrophil count<1.0×10^9/L, Hemoglobin <80 g/L, Platelets <50×10^9/L
Inadequate organ function, defined by the following: Total bilirubin >1.5 times the upper limit of normal (× ULN), aspartate aminotransferase and/or alanine aminotransferase >2.5 × ULN, Estimated Creatinine Clearance (CrCl) per Cockcroft-Gault [Dose Escalation portion of trial (Stage 1) CrCl < 40 mL/min, Dose Expansion portion of trial (Stage 2) CrCl < 30 mL/min], Serum amylase or lipase >ULN, International normalized ratio >1.5 × ULN, or activated partial thromboplastin time >1.5 × ULN
Patients with clinically detectable second primary malignant tumors at enrollment or other malignant tumors within the last 2 years (with the exception of radically treated basal cell or squamous cell carcinoma of the skin, in situ cervix, or in situ breast cancer).
Any anticancer therapy, including chemotherapy, hormonal therapy, biologic therapy, vaccine, or radiotherapy within 3 weeks prior to the initiation of study treatment.
Herbal therapy within 1 week prior to the initiation of study treatment.
Prior use of any anti-cancer vaccine
Prior treatment with any spleen tyrosine kinase (SYK) inhibitors (eg, fostamatinib)
Prior administration of radioimmunotherapy within 3 months before initiation of study treatment.
Use of strong cytochrome P450 isoform 3A inhibitors and inducers and drugs metabolized by cytochrome P450 isoform 3A, cytochrome P450 isoform 2B6, and cytochrome P450 isoform 1A2, and are identified as narrow therapeutic drugs within 7 days or 3 half-lives, whichever is longer, prior to initiation of study treatment
Adverse events from prior anticancer therapy that have not resolved to Grade ≤1, except for alopecia.
Prior autologous stem cell transplant within 6 months prior to the initiation of study treatment.
Prior allogeneic stem cell transplant within 6 months prior to the initiation of study treatment or with any evidence of active graft versus host disease or requirement for immunosuppressants within 28 days prior to the initiation of study treatment.
Clinically significant active infection (eg, pneumonia).
Major surgical procedure within 4 weeks prior to the initiation of study treatment.
Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus.
Pregnant (positive serum beta human chorionic gonadotropin test) or lactating women.
New York Heart Association Class II or greater congestive heart failure.
Congenital long QT syndrome or correct QT interval using Fridericia's formula (QTcF) >480 msec
Current use of medication known to cause QT prolongation or Torsades de Pointes
History of myocardial infarction or unstable angina within 6 months prior to the initiation of study treatment.
History of stroke or transient ischemic attack within 6 months prior to the initiation of study treatment.
Inability to take oral medication, prior surgical procedures affecting absorption, or active peptic ulcer disease.
Treatment in a clinical study within 30 days prior to the initiation of study treatment.
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, or renders the patient at high risk from treatment complications.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Michael Shi, MD
Hutchmed
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Pacific Cancer Medical Center, Inc.
Anaheim
California
92801
United States
Innovative Clinical Research Institute
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
A total of 87 patients were screened for this study (24 in dose escalation stage [Stage 1] and 63 in dose expansion stage [Stage 2]), out of which 18 patients were screen failures (3 in dose escalation and 15 in dose expansion stages). A total of 21 patients in dose escalation stage and 48 patients in dose expansion stage were enrolled in this study and received at least one dose of HMPL-523.
Recruitment Details
This Phase 1 open-label study was conducted in patients with relapsed or refractory lymphoma who had exhausted approved therapy options. Study recruitment was terminated based on a strategic decision made by the Sponsor to discontinue development of HMPL-523 for lymphoma in the United States, Europe, and Australia with no safety concerns.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Dose Escalation Stage: HMPL-523 100 mg QD
Patients received HMPL-523 100 milligram (mg) tablet orally once daily (QD) from Cycle 1 Day 1 until disease progression (PD), intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jun 14, 2024
Dec 3, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
From the first dose of study treatment (Day 1) up to Day 28 of Cycle 1 (each cycle was 28 days)
ORR:percentage of patients who had best overall response (BOR) with complete response (CR),CR with incomplete marrow recovery (CRi),nodular partial response (nPR) or PR for CLL patients; CR, very good PR(VGPR), PR or minor response(MR) for WM patients; CR or PR for patients with disease type other than CLL and WM. BOR:best response from start of treatment until progression or any further anticancer therapy.CR:absence of serum(S) monoclonal immunoglobulin (Ig)M, normal S IgM, complete resolution of extramedullary disease,morphologically normal bone marrow aspirate and trephine biopsy. CRi:criteria fulfilled for CR but persistent cytopenia, anemia, thrombocytopenia or neutropenia. nPR:patients with residual CLL cells. PR, VGPR, MR:detectable monoclonal IgM,no new signs/symptoms of active disease and PR:>=50% but <90% reduction in S IgM,reduction in extramedullary disease,VGPR: >=90% reduction in S IgM, complete resolution of extramedullary disease, MR: >=25% but <50% reduction in S IgM.
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months
Dose Expansion Stage: Complete Response Rate
CR rate was defined as the percentage of patients who had BOR with CR or CRi for CLL patients, and CR only for other patients. BOR was defined as the best response from start of treatment until progression or any further anticancer therapy. CR was defined as the absence of serum monoclonal IgM, normal serum IgM, complete resolution of extramedullary disease, morphologically normal bone marrow aspirate and trephine biopsy. CRi was defined as the criteria fulfilled for CR but persistent cytopenia, anemia, thrombocytopenia or neutropenia.
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months
Dose Expansion Stage: Clinical Benefit Rate (CBR)
CBR was defined as the percentage of patients who had BOR of stable disease (SD) or better. BOR was defined as the best response from start of treatment until progression or any further anticancer therapy. SD was defined as detectable monoclonal IgM, <25% reduction and <25% increase in serum IgM level, no progression in extramedullary disease, no new signs/symptoms of active disease.
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months
Dose Expansion Stage: Duration of Response (DOR)
DOR: time from when first response (CR, CRi, PR, nPR, VGPR, PR-L, and MR) was achieved until earlier of first documentation of definitive PD or death from any cause. CR: absence of S monoclonal IgM, normal S IgM, complete resolution of extramedullary disease, morphologically normal bone marrow aspirate and trephine biopsy. CRi: criteria fulfilled for CR but persistent cytopenia, anemia, thrombocytopenia or neutropenia. nPR: patients with residual CLL cells. PR-L: patients achieved PR with CLL-related signs/symptoms other than lymphocytosis and continued on therapy. PR, VGPR,MR:detectable monoclonal IgM,no new signs/symptoms of active disease and PR: >=50% but <90% reduction in S IgM,reduction in extramedullary disease,VGPR: >=90% reduction in S IgM,complete resolution of extramedullary disease,MR: >=25% but <50% reduction in S IgM. PD: >=25% increase in S IgM level from lowest nadir and/or progression in clinical features attributable to disease.
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months
Dose Expansion Stage: Time to Response (TTR)
TTR was defined as the time from the first dose of study treatment to the first occurrence of CR, CRi, PR, nPR, VGPR, PR-L, or MR. CR: absence of serum monoclonal IgM, normal serum IgM, complete resolution of extramedullary disease, morphologically normal bone marrow aspirate and trephine biopsy. CRi: criteria fulfilled for CR but persistent cytopenia, anemia, thrombocytopenia or neutropenia. nPR: patients with residual CLL cells. PR-L: patients achieved PR with CLL-related signs/symptoms other than lymphocytosis and continued on therapy. PR, VGPR, MR: detectable monoclonal IgM, no new signs/symptoms of active disease and PR: >=50% but <90% reduction in serum IgM, reduction in extramedullary disease, VGPR: >=90% reduction in serum IgM, complete resolution of extramedullary disease, MR: >=25% but <50% reduction in serum IgM. Kaplan Meier analysis included only the responders.
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months
PFS was defined as the time from the date of first study treatment to the earliest date of PD or death due to any reason whichever occurred first. PD was defined as >=25% increase in serum IgM level from lowest nadir and/or progression in clinical features attributable to disease.
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months
Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 1, 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 1 and 28 of Cycle 1
Dose Escalation Stage and Dose Expansion Stage: Time to Reach Maximum Plasma Concentration (Tmax) of HMPL-523
Blood samples were collected to determine tmax of HMPL-523. The PK parameters were determined by non-compartmental analysis. Eventually, the patients discontinued as they progressed in the study. Hence, fewer patients at each cycle and no patients returned on Cycle 1 Day 28 in dose expansion stage: MZL arm.
Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 1, 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 1 and 28 of Cycle 1
Dose Escalation Stage and Dose Expansion Stage: Area Under the Concentration-Time Curve From Time Zero (Pre-Dose) to Time of Last Quantifiable Concentration (AUC0-t) of HMPL-523
Blood samples were collected to determine AUC0-t of HMPL-523. The PK parameters were determined by non-compartmental analysis.
Dose escalation and dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Day 1 of Cycle 1
Dose Escalation Stage and Dose Expansion Stage: Area Under the Concentration-Time Curve During a Dosing Interval (AUCtau) of HMPL-523
Blood samples were collected to determine AUCtau of HMPL-523. The PK parameters were determined by non-compartmental analysis. Eventually, the patients discontinued as they progressed in the study. Hence, fewer patients at each cycle and no patients returned on Cycle 1 Day 28 in dose escalation stage: HMPL-523 800 mg QD and dose expansion stage: MZL arms.
Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 1, 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 1 and 28 of Cycle 1
Dose Escalation Stage and Dose Expansion Stage: Apparent Systemic Clearance (CL/F) of HMPL-523
Blood samples were collected to determine CL/F of HMPL-523. The PK parameters were determined by non-compartmental analysis. Eventually, the patients discontinued as they progressed in the study. Hence, fewer patients at each cycle and no patients returned on Cycle 1 Day 28 in dose escalation stage: HMPL-523 800 mg QD and dose expansion stage: MZL arms.
Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Day 28 of Cycle 1
Dose Escalation Stage and Dose Expansion Stage: Minimum Plasma Concentration (Cmin) of HMPL-523
Blood samples were collected to determine Cmin of HMPL-523. The PK parameters were determined by non-compartmental analysis. Eventually, the patients discontinued as they progressed in the study. Hence, fewer patients at each cycle and no patients returned on Cycle 1 Day 28 in dose escalation stage: HMPL-523 800 mg QD and dose expansion stage: MZL arms.
Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Day 28 of Cycle 1
Dose Escalation Stage and Dose Expansion Stage: Ratio of Metabolite to Parent Maximum Plasma Concentration (MRCmax)
Blood samples were collected to determine MRCmax. The metabolites of HMPL-523 were M1 (HM5023222) and M44 (HM5025866) only. The PK parameters were determined by non-compartmental analysis. Eventually, the patients discontinued as they progressed in the study. Hence, fewer patients at each cycle and no patients returned on Cycle 1 Day 28 in dose expansion stage: MZL arm.
Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Day 28 of Cycle 1
Dose Escalation Stage and Dose Expansion Stage: Ratio of Metabolite to Parent Area Under the Concentration-Time Curve During a Dosing Interval (MRAUCtau)
Blood samples were collected to determine MRAUCtau. The metabolites of HMPL-523 were M1 (HM5023222) and M44 (HM5025866) only. The PK parameters were determined by non-compartmental analysis. Eventually, the patients discontinued as they progressed in the study. Hence, fewer patients at each cycle and no patients returned on Cycle 1 Day 28 in dose escalation stage: HMPL-523 800 mg QD and dose expansion stage: MZL arms.
Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Day 28 of Cycle 1
Dose Escalation Stage and Dose Expansion Stage: Accumulation Ratio for Maximum Plasma Concentration (RA[Cmax]) of HMPL-523
Blood samples were collected to determine RA(Cmax) of HMPL-523. The PK parameters were determined by non-compartmental analysis. Eventually, the patients discontinued as they progressed in the study. Hence, fewer patients at each cycle and no patients returned on Cycle 1 Day 28 in dose expansion stage: MZL arm.
Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Day 28 of Cycle 1
Dose Escalation Stage and Dose Expansion Stage: Accumulation Ratio for Area Under the Concentration-Time Curve During a Dosing Interval (RA[AUC]) of HMPL-523
Blood samples were collected to determine RA(AUC) of HMPL-523. The PK parameters were determined by non-compartmental analysis. Eventually, the patients discontinued as they progressed in the study. Hence, fewer patients at each cycle and no patients returned on Cycle 1 Day 28 in dose escalation stage: HMPL-523 800 mg QD and dose expansion stage: MZL arms.
Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Day 28 of Cycle 1
Dose Expansion Stage: Number of Patients With Treatment-Emergent Adverse Events, Treatment Related Treatment-Emergent Adverse Events, Treatment-Emergent Adverse Events Leading to Treatment Interruption, Treatment Reduction and Treatment Discontinuation
An AE was any untoward medical occurrence in a clinical study patient temporally associated with the use of a study treatment, whether or not considered related to the treatment. TEAEs were defined as AEs with an onset date on or after the first dose of study treatment and no later than 30 days after the date of last study treatment administration or start of a new treatment of anti-neoplasm therapy, whichever was earlier. Treatment related AEs were the TEAEs that were reported as related to study treatment by the Investigator.
From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months
Dose Escalation Stage: Objective Response Rate
ORR: percentage of patients who had BOR with CR, CRi, nPR or PR for CLL patients; CR, VGPR, PR or MR for WM patients; CR or PR for patients with disease type other than CLL and WM. BOR: best response from start of treatment until progression or any further anticancer therapy. CR: absence of S monoclonal IgM, normal S IgM, complete resolution of extramedullary disease, morphologically normal bone marrow aspirate and trephine biopsy. CRi: criteria fulfilled for CR but persistent cytopenia, anemia, thrombocytopenia or neutropenia. nPR: patients with residual CLL cells. PR, VGPR, MR: detectable monoclonal IgM, no new signs/symptoms of active disease and PR: >=50% but <90% reduction in S IgM, reduction in extramedullary disease, VGPR: >=90% reduction in S IgM, complete resolution of extramedullary disease, MR: >=25% but <50% reduction in S IgM.
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months
Dose Escalation Stage: Complete Response Rate
CR rate was defined as the percentage of patients who had BOR with CR or CRi for CLL patients, and CR only for other patients. BOR was defined as the best response from start of treatment until progression or any further anticancer therapy. CR was defined as the absence of serum monoclonal IgM, normal serum IgM, complete resolution of extramedullary disease, morphologically normal bone marrow aspirate and trephine biopsy. CRi was defined as the criteria fulfilled for CR but persistent cytopenia, anemia, thrombocytopenia or neutropenia.
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months
Dose Escalation Stage: Clinical Benefit Rate
CBR was defined as the percentage of patients who had BOR of SD or better. BOR was defined as the best response from start of treatment until progression or any further anticancer therapy. SD was defined as detectable monoclonal IgM, <25% reduction and <25% increase in serum IgM level, no progression in extramedullary disease, no new signs/symptoms of active disease.
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months
Dose Escalation Stage: Duration of Response
DOR: time from when first response (CR, CRi, PR, nPR, VGPR, PR-L, and MR) was achieved until earlier of first documentation of definitive PD or death from any cause. CR: absence of S monoclonal IgM, normal S IgM, complete resolution of extramedullary disease, morphologically normal bone marrow aspirate and trephine biopsy. CRi: criteria fulfilled for CR but persistent cytopenia, anemia, thrombocytopenia or neutropenia. nPR: patients with residual CLL cells. PR-L: patients achieved PR with CLL-related signs/symptoms other than lymphocytosis and continued on therapy. PR, VGPR, MR: detectable monoclonal IgM, no new signs/symptoms of active disease and PR: >=50% but <90% reduction in S IgM, reduction in extramedullary disease, VGPR: >=90% reduction in S IgM, complete resolution of extramedullary disease, MR: >=25% but <50% reduction in S IgM. PD: >=25% increase in S IgM level from lowest nadir and/or progression in clinical features attributable to disease.
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months
Dose Escalation Stage: Time to Response
TTR was defined as the time from the first dose of study treatment to the first occurrence of CR, CRi, PR, nPR, VGPR, PR-L, or MR. CR: absence of S monoclonal IgM, normal S IgM, complete resolution of extramedullary disease, morphologically normal bone marrow aspirate and trephine biopsy. CRi: criteria fulfilled for CR but persistent cytopenia, anemia, thrombocytopenia or neutropenia. nPR: patients with residual CLL cells. PR-L: patients achieved PR with CLL-related signs/symptoms other than lymphocytosis and continued on therapy. PR, VGPR, MR: detectable monoclonal IgM, no new signs/symptoms of active disease and PR: >=50% but <90% reduction in S IgM, reduction in extramedullary disease, VGPR: >=90% reduction in S IgM, complete resolution of extramedullary disease, MR: >=25% but <50% reduction in S IgM. Kaplan Meier analysis included only the responders.
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months
Dose Escalation Stage: Progression-Free Survival
PFS was defined as the time from the date of first study treatment to the earliest date of PD or death due to any reason whichever occurred first. PD was defined as >=25% increase in serum IgM level from lowest nadir and/or progression in clinical features attributable to disease.
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months
Downey
California
90241
United States
Ventura County Hematology-Oncology Specialists
Oxnard
California
93030
United States
Summit Medical Group
Florham Park
New Jersey
07932
United States
Clinical Research Alliance
New Hyde Park
New York
11042
United States
Leo Jenkins Cancer Center/ECU School of Medicine
Greenville
North Carolina
27834
United States
The University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Renovatio Clinical
The Woodlands
Texas
77380
United States
Aarhus University Hospital
Aarhus
Denmark
Helsingin yliopistollinen keskussairaala
Helsinki
00029
Finland
Tampereen yliopistollinen sairaala
Tampere
33520
Finland
CHU Clermont Ferrand - Hôpital d'Estaing
Clermont-Ferrand
France
Hôpital Henri Mondor
Créteil
France
Groupe Hospitalier Pitie-Salpetriere
Paris
France
CHU Poitiers - Hôpital la Milétrie
Poitiers
France
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo
Bergamo
24127
Italy
Ospedale San Raffaele
Milan
Milano
20132
Italy
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
Monza
Italy
KO-MED Centra Kliniczne
Biała Podlaska
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk
Poland
Nasz Lekarz Przychodnie Medyczne
Torun
Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego
Wroclaw
50566
Poland
Hospital Universitari Vall d'Hebron
Barcelona
Spain
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Barcelona
Spain
Institut Català d'Oncologia
Barcelona
Spain
Hospital Universitario Ramon y Cajal
Madrid
28034
Spain
Fundacion Jimenez Diaz
Madrid
Spain
Hospital Universitario Infanta Leonor
Madrid
Spain
Hospital Universitario Quironsalud Madrid
Madrid
Spain
MD Anderson Cancer Centre
Madrid
Spain
Hospital Universitario Virgen del Rocio
Seville
Spain
Hospital Universitario Virgen Macarena
Seville
Spain
FG001
Dose Escalation Stage: HMPL-523 200 mg QD
Patients received HMPL-523 200 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
FG002
Dose Escalation Stage: HMPL-523 400 mg QD
Patients received HMPL-523 400 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
FG003
Dose Escalation Stage: HMPL-523 600 mg QD
Patients received HMPL-523 600 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
FG004
Dose Escalation Stage: HMPL-523 700 mg QD
Patients received HMPL-523 700 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
FG005
Dose Escalation Stage: HMPL-523 800 mg QD
Patients received HMPL-523 800 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
FG006
Dose Expansion Stage: HL
Patients with Hodgkin's lymphoma (HL) received HMPL-523 700 mg (recommended phase 2 dose [RP2D]) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
FG007
Dose Expansion Stage: CLL
Patients with chronic lymphocytic leukemia (CLL) received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
FG008
Dose Expansion Stage: CLL-post BTK
Patients with CLL-post Bruton tyrosine kinase (BTK) received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
FG009
Dose Expansion Stage: FL
Patients with follicular lymphoma (FL) received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
FG010
Dose Expansion Stage: MZL
Patients with marginal zone lymphoma (MZL) received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
FG011
Dose Expansion Stage: LPL/WM
Patients with lymphoplasmacytic lymphoma (LPL)/ Waldenström's macroglobulinemia (WM) received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
FG012
Dose Expansion Stage: MCL
Patients with mantle cell lymphoma (MCL) received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
FG013
Dose Expansion Stage: PTCL
Patients with peripheral T-cell lymphoma (PTCL) received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
FG0004 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0044 subjects
FG0054 subjects
FG00625 subjects
FG0071 subjects
FG0087 subjects
FG0092 subjects
FG0101 subjects
FG0111 subjects
FG0122 subjects
FG0139 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
NOT COMPLETED
FG0004 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0044 subjects
FG0054 subjects
FG00625 subjects
FG0071 subjects
FG0087 subjects
FG0092 subjects
FG0101 subjects
FG0111 subjects
FG0122 subjects
FG0139 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Progressive Disease
FG0003 subjects
FG0012 subjects
FG0022 subjects
FG0031 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Anti-neoplasm treatment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Study terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The Full Analysis Set (FAS) included all patients who received at least 1 dose of HMPL-523.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Dose Escalation Stage: HMPL-523 100 mg QD
Patients received HMPL-523 100 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
BG001
Dose Escalation Stage: HMPL-523 200 mg QD
Patients received HMPL-523 200 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
BG002
Dose Escalation Stage: HMPL-523 400 mg QD
Patients received HMPL-523 400 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
BG003
Dose Escalation Stage: HMPL-523 600 mg QD
Patients received HMPL-523 600 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
BG004
Dose Escalation Stage: HMPL-523 700 mg QD
Patients received HMPL-523 700 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
BG005
Dose Escalation Stage: HMPL-523 800 mg QD
Patients received HMPL-523 800 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
BG006
Dose Expansion Stage: HL
Patients with HL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
BG007
Dose Expansion Stage: CLL
Patients with CLL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
BG008
Dose Expansion Stage: CLL-post BTK
Patients with CLL-post BTK received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
BG009
Dose Expansion Stage: FL
Patients with FL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
BG010
Dose Expansion Stage: MZL
Patients with MZL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
BG011
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
BG012
Dose Expansion Stage: MCL
Patients with MCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
BG013
Dose Expansion Stage: PTCL
Patients with PTCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
BG014
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0013
BG0023
BG0033
BG0044
BG0054
BG00625
BG0071
BG0087
BG0092
BG0101
BG0111
BG0122
BG0139
BG01469
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00069.8± 11.12
BG00155.0± 7.00
BG00257.7± 30.09
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0011
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
BG0004
BG0012
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG0002
BG0012
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Dose Escalation Stage: Number of Patients With Dose-Limiting Toxicities (DLTs)
A DLT was defined as the occurrence of any of the following treatment-emergent adverse events (TEAEs) during the DLT assessment window, unless clearly unrelated to the study treatment. AEs were graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0: non-hematologic toxicity: all non-hematologic TEAEs of Grade 3 or greater with the exception of Grade 3 nausea or vomiting controlled by supportive therapy; hematologic toxicity: Grade 4 neutropenia >5 days, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or which required platelets transfusion, Grade >=3 febrile neutropenia (defined as absolute neutrophil count <1000/cubic millimeter with a single temperature >38.3 degree Celsius [°C] or a sustained temperature of >=38°C for more than 1 hour), Grade 4 anemia not explained by underlying disease; any TEAE that required a dose delay of >=15 days; any case of Hy's Law.
The DLT evaluable analysis set was defined as all patients enrolled in the dose escalation stage of the study who were evaluable for DLT assessment. A patient was DLT evaluable if: had received at least 75% of the assigned dose of study treatment during the DLT assessment window or had not completed the DLT assessment period due to a DLT.
Posted
Count of Participants
Participants
No
From the first dose of study treatment (Day 1) up to Day 28 of Cycle 1 (each cycle was 28 days)
ID
Title
Description
OG000
Dose Escalation Stage: HMPL-523 100 mg QD
Patients received HMPL-523 100 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG001
Dose Escalation Stage: HMPL-523 200 mg QD
Patients received HMPL-523 200 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG002
Dose Escalation Stage: HMPL-523 400 mg QD
Patients received HMPL-523 400 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Escalation Stage: HMPL-523 600 mg QD
Patients received HMPL-523 600 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Escalation Stage: HMPL-523 700 mg QD
Patients received HMPL-523 700 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0020
OG003
Primary
Dose Escalation Stage: Number of Patients With Treatment-Emergent Adverse Events, Treatment Related Treatment-Emergent Adverse Events, Treatment-Emergent Adverse Events Leading to Treatment Interruption, Treatment Reduction and Treatment Discontinuation
An AE was any untoward medical occurrence in a clinical study patient temporally associated with the use of a study treatment, whether or not considered related to the treatment. TEAEs were defined as AEs with an onset date on or after the first dose of study treatment and no later than 30 days after the date of last study treatment administration or start of a new treatment of anti-neoplasm therapy, whichever was earlier. Treatment related AEs were the TEAEs that were reported as related to study treatment by the Investigator.
The FAS included all patients who received at least 1 dose of HMPL-523.
Posted
Count of Participants
Participants
No
From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months
ID
Title
Description
OG000
Dose Escalation Stage: HMPL-523 100 mg QD
Patients received HMPL-523 100 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG001
Dose Escalation Stage: HMPL-523 200 mg QD
Patients received HMPL-523 200 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Primary
Dose Escalation Stage: Recommended Phase 2 Dose of HMPL-523
RP2D was based on the pharmacokinetics (PK), safety, and tolerability assessments in dose escalation stage patients.
The FAS included all patients who received at least 1 dose of HMPL-523.
Posted
Number
mg
From the first dose of study treatment (Day 1) up to Day 28 of Cycle 1 (each cycle was 28 days)
ID
Title
Description
OG000
Dose Escalation Stage: HMPL-523
Patients received HMPL-523 100 mg, 200 mg, 400 mg, 600 mg, 700 mg and 800 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
ORR:percentage of patients who had best overall response (BOR) with complete response (CR),CR with incomplete marrow recovery (CRi),nodular partial response (nPR) or PR for CLL patients; CR, very good PR(VGPR), PR or minor response(MR) for WM patients; CR or PR for patients with disease type other than CLL and WM. BOR:best response from start of treatment until progression or any further anticancer therapy.CR:absence of serum(S) monoclonal immunoglobulin (Ig)M, normal S IgM, complete resolution of extramedullary disease,morphologically normal bone marrow aspirate and trephine biopsy. CRi:criteria fulfilled for CR but persistent cytopenia, anemia, thrombocytopenia or neutropenia. nPR:patients with residual CLL cells. PR, VGPR, MR:detectable monoclonal IgM,no new signs/symptoms of active disease and PR:>=50% but <90% reduction in S IgM,reduction in extramedullary disease,VGPR: >=90% reduction in S IgM, complete resolution of extramedullary disease, MR: >=25% but <50% reduction in S IgM.
The response evaluable set (RES) included all patients who received at least 1 dose of HMPL-523, had a baseline tumor measurement, and had at least 1 post-baseline tumor measurement or clinical restaging, unless death occurred before the first post-baseline assessment.
Posted
Number
95% Confidence Interval
percentage of patients
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months
ID
Title
Description
OG000
Dose Expansion Stage: HL
Patients with HL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Primary
Dose Expansion Stage: Complete Response Rate
CR rate was defined as the percentage of patients who had BOR with CR or CRi for CLL patients, and CR only for other patients. BOR was defined as the best response from start of treatment until progression or any further anticancer therapy. CR was defined as the absence of serum monoclonal IgM, normal serum IgM, complete resolution of extramedullary disease, morphologically normal bone marrow aspirate and trephine biopsy. CRi was defined as the criteria fulfilled for CR but persistent cytopenia, anemia, thrombocytopenia or neutropenia.
The RES included all patients who received at least 1 dose of HMPL-523, had a baseline tumor measurement, and had at least 1 post-baseline tumor measurement or clinical restaging, unless death occurred before the first post-baseline assessment.
Posted
Number
95% Confidence Interval
percentage of patients
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months
ID
Title
Description
OG000
Dose Expansion Stage: HL
Patients with HL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG001
Dose Expansion Stage: CLL
Primary
Dose Expansion Stage: Clinical Benefit Rate (CBR)
CBR was defined as the percentage of patients who had BOR of stable disease (SD) or better. BOR was defined as the best response from start of treatment until progression or any further anticancer therapy. SD was defined as detectable monoclonal IgM, <25% reduction and <25% increase in serum IgM level, no progression in extramedullary disease, no new signs/symptoms of active disease.
The RES included all patients who received at least 1 dose of HMPL-523, had a baseline tumor measurement, and had at least 1 post-baseline tumor measurement or clinical restaging, unless death occurred before the first post-baseline assessment.
Posted
Number
95% Confidence Interval
percentage of patients
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months
ID
Title
Description
OG000
Dose Expansion Stage: HL
Patients with HL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG001
Dose Expansion Stage: CLL
Patients with CLL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Primary
Dose Expansion Stage: Duration of Response (DOR)
DOR: time from when first response (CR, CRi, PR, nPR, VGPR, PR-L, and MR) was achieved until earlier of first documentation of definitive PD or death from any cause. CR: absence of S monoclonal IgM, normal S IgM, complete resolution of extramedullary disease, morphologically normal bone marrow aspirate and trephine biopsy. CRi: criteria fulfilled for CR but persistent cytopenia, anemia, thrombocytopenia or neutropenia. nPR: patients with residual CLL cells. PR-L: patients achieved PR with CLL-related signs/symptoms other than lymphocytosis and continued on therapy. PR, VGPR,MR:detectable monoclonal IgM,no new signs/symptoms of active disease and PR: >=50% but <90% reduction in S IgM,reduction in extramedullary disease,VGPR: >=90% reduction in S IgM,complete resolution of extramedullary disease,MR: >=25% but <50% reduction in S IgM. PD: >=25% increase in S IgM level from lowest nadir and/or progression in clinical features attributable to disease.
The RES included all patients who received at least 1 dose of HMPL-523, had a baseline tumor measurement, and had at least 1 post-baseline tumor measurement or clinical restaging, unless death occurred before the first post-baseline assessment. Only patients with response of CR, CRi, PR, nPR, VGPR, PR-L, or MR were included in the analysis.
Posted
Median
95% Confidence Interval
months
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months
ID
Title
Description
OG000
Dose Expansion Stage: HL
Patients with HL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Primary
Dose Expansion Stage: Time to Response (TTR)
TTR was defined as the time from the first dose of study treatment to the first occurrence of CR, CRi, PR, nPR, VGPR, PR-L, or MR. CR: absence of serum monoclonal IgM, normal serum IgM, complete resolution of extramedullary disease, morphologically normal bone marrow aspirate and trephine biopsy. CRi: criteria fulfilled for CR but persistent cytopenia, anemia, thrombocytopenia or neutropenia. nPR: patients with residual CLL cells. PR-L: patients achieved PR with CLL-related signs/symptoms other than lymphocytosis and continued on therapy. PR, VGPR, MR: detectable monoclonal IgM, no new signs/symptoms of active disease and PR: >=50% but <90% reduction in serum IgM, reduction in extramedullary disease, VGPR: >=90% reduction in serum IgM, complete resolution of extramedullary disease, MR: >=25% but <50% reduction in serum IgM. Kaplan Meier analysis included only the responders.
The RES included all patients who received at least 1 dose of HMPL-523, had a baseline tumor measurement, and had at least 1 post-baseline tumor measurement or clinical restaging, unless death occurred before the first post-baseline assessment. Only patients with response of CR, CRi, PR, nPR, VGPR, PR-L, or MR were included in the analysis.
Posted
Median
95% Confidence Interval
months
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months
ID
Title
Description
OG000
Dose Expansion Stage: HL
Patients with HL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
PFS was defined as the time from the date of first study treatment to the earliest date of PD or death due to any reason whichever occurred first. PD was defined as >=25% increase in serum IgM level from lowest nadir and/or progression in clinical features attributable to disease.
The FAS included all patients who received at least 1 dose of HMPL-523.
Posted
Median
95% Confidence Interval
months
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months
ID
Title
Description
OG000
Dose Expansion Stage: HL
Patients with HL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG001
Dose Expansion Stage: CLL
Patients with CLL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Secondary
Dose Escalation Stage and Dose Expansion Stage: Maximum Plasma Concentration (Cmax) of HMPL-523
Blood samples were collected to determine Cmax of HMPL-523. The PK parameters were determined by non-compartmental analysis. Eventually, the patients discontinued as they progressed in the study. Hence, fewer patients at each cycle and no patients returned on Cycle 1 Day 28 in dose expansion stage: MZL arm.
PK analysis set (PKAS) included all patients who received at least 1 dose of HMPL-523 and had at least 1 PK sample obtained and analyzed. As pre-specified in statistical analysis plan (SAP), results are presented by disease groups and combined data for CLL and CLL-post BTK arms in dose expansion stage is presented for all patients evaluable for this endpoint who received HMPL-523 at RP2D (700 mg QD) in dose expansion stage. Only patients with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
nanograms per milliliter (ng/mL)
Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 1, 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 1 and 28 of Cycle 1
ID
Title
Description
OG000
Dose Escalation Stage: HMPL-523 100 mg QD
Patients received HMPL-523 100 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG001
Dose Escalation Stage: HMPL-523 200 mg QD
Secondary
Dose Escalation Stage and Dose Expansion Stage: Time to Reach Maximum Plasma Concentration (Tmax) of HMPL-523
Blood samples were collected to determine tmax of HMPL-523. The PK parameters were determined by non-compartmental analysis. Eventually, the patients discontinued as they progressed in the study. Hence, fewer patients at each cycle and no patients returned on Cycle 1 Day 28 in dose expansion stage: MZL arm.
The PKAS included all patients who received at least 1 dose of HMPL-523 and had at least 1 PK sample obtained and analyzed. As pre-specified in the SAP, the results are presented by disease groups and combined data for CLL and CLL-post BTK arms in the dose expansion stage is presented for all patients evaluable for this endpoint who received HMPL-523 at RP2D (700 mg QD) in dose expansion stage. Only patients with data collected at specified timepoints are reported.
Posted
Median
Full Range
hour (h)
Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 1, 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 1 and 28 of Cycle 1
ID
Title
Description
OG000
Dose Escalation Stage: HMPL-523 100 mg QD
Patients received HMPL-523 100 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG001
Dose Escalation Stage: HMPL-523 200 mg QD
Secondary
Dose Escalation Stage and Dose Expansion Stage: Area Under the Concentration-Time Curve From Time Zero (Pre-Dose) to Time of Last Quantifiable Concentration (AUC0-t) of HMPL-523
Blood samples were collected to determine AUC0-t of HMPL-523. The PK parameters were determined by non-compartmental analysis.
The PKAS included all patients who received at least 1 dose of HMPL-523 and had at least 1 PK sample obtained and analyzed. As pre-specified in the SAP, the results are presented by disease groups and combined data for CLL and CLL-post BTK arms in the dose expansion stage is presented for all patients evaluable for this endpoint who received HMPL-523 at RP2D (700 mg QD) in dose expansion stage. Only patients with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ng*h/mL
Dose escalation and dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Day 1 of Cycle 1
ID
Title
Description
OG000
Dose Escalation Stage: HMPL-523 100 mg QD
Patients received HMPL-523 100 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG001
Dose Escalation Stage: HMPL-523 200 mg QD
Patients received HMPL-523 200 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Secondary
Dose Escalation Stage and Dose Expansion Stage: Area Under the Concentration-Time Curve During a Dosing Interval (AUCtau) of HMPL-523
Blood samples were collected to determine AUCtau of HMPL-523. The PK parameters were determined by non-compartmental analysis. Eventually, the patients discontinued as they progressed in the study. Hence, fewer patients at each cycle and no patients returned on Cycle 1 Day 28 in dose escalation stage: HMPL-523 800 mg QD and dose expansion stage: MZL arms.
The PKAS included all patients who received at least 1 dose of HMPL-523 and had at least 1 PK sample obtained and analyzed. As pre-specified in the SAP, the results are presented by disease groups and combined data for CLL and CLL-post BTK arms in the dose expansion stage is presented for all patients evaluable for this endpoint who received HMPL-523 at RP2D (700 mg QD) in dose expansion stage. Only patients with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ng*h/mL
Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 1, 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 1 and 28 of Cycle 1
ID
Title
Description
OG000
Dose Escalation Stage: HMPL-523 100 mg QD
Patients received HMPL-523 100 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG001
Dose Escalation Stage: HMPL-523 200 mg QD
Secondary
Dose Escalation Stage and Dose Expansion Stage: Apparent Systemic Clearance (CL/F) of HMPL-523
Blood samples were collected to determine CL/F of HMPL-523. The PK parameters were determined by non-compartmental analysis. Eventually, the patients discontinued as they progressed in the study. Hence, fewer patients at each cycle and no patients returned on Cycle 1 Day 28 in dose escalation stage: HMPL-523 800 mg QD and dose expansion stage: MZL arms.
The PKAS included all patients who received at least 1 dose of HMPL-523 and had at least 1 PK sample obtained and analyzed. As pre-specified in the SAP, the results are presented by disease groups and combined data for CLL and CLL-post BTK arms in the dose expansion stage is presented for all patients evaluable for this endpoint who received HMPL-523 at RP2D (700 mg QD) in dose expansion stage. Only patients with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
Liter/h
Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Day 28 of Cycle 1
ID
Title
Description
OG000
Dose Escalation Stage: HMPL-523 100 mg QD
Patients received HMPL-523 100 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG001
Dose Escalation Stage: HMPL-523 200 mg QD
Secondary
Dose Escalation Stage and Dose Expansion Stage: Minimum Plasma Concentration (Cmin) of HMPL-523
Blood samples were collected to determine Cmin of HMPL-523. The PK parameters were determined by non-compartmental analysis. Eventually, the patients discontinued as they progressed in the study. Hence, fewer patients at each cycle and no patients returned on Cycle 1 Day 28 in dose escalation stage: HMPL-523 800 mg QD and dose expansion stage: MZL arms.
The PKAS included all patients who received at least 1 dose of HMPL-523 and had at least 1 PK sample obtained and analyzed. As pre-specified in the SAP, the results are presented by disease groups and combined data for CLL and CLL-post BTK arms in the dose expansion stage is presented for all patients evaluable for this endpoint who received HMPL-523 at RP2D (700 mg QD) in dose expansion stage. Only patients with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ng/mL
Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Day 28 of Cycle 1
ID
Title
Description
OG000
Dose Escalation Stage: HMPL-523 100 mg QD
Patients received HMPL-523 100 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG001
Dose Escalation Stage: HMPL-523 200 mg QD
Secondary
Dose Escalation Stage and Dose Expansion Stage: Ratio of Metabolite to Parent Maximum Plasma Concentration (MRCmax)
Blood samples were collected to determine MRCmax. The metabolites of HMPL-523 were M1 (HM5023222) and M44 (HM5025866) only. The PK parameters were determined by non-compartmental analysis. Eventually, the patients discontinued as they progressed in the study. Hence, fewer patients at each cycle and no patients returned on Cycle 1 Day 28 in dose expansion stage: MZL arm.
The PKAS included all patients who received at least 1 dose of HMPL-523 and had at least 1 PK sample obtained and analyzed. As pre-specified in the SAP, the results are presented by disease groups and combined data for CLL and CLL-post BTK arms in the dose expansion stage is presented for all patients evaluable for this endpoint who received HMPL-523 at RP2D (700 mg QD) in dose expansion stage. Only patients with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ratio
Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Day 28 of Cycle 1
ID
Title
Description
OG000
Dose Escalation Stage: HMPL-523 100 mg QD
Patients received HMPL-523 100 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG001
Dose Escalation Stage: HMPL-523 200 mg QD
Secondary
Dose Escalation Stage and Dose Expansion Stage: Ratio of Metabolite to Parent Area Under the Concentration-Time Curve During a Dosing Interval (MRAUCtau)
Blood samples were collected to determine MRAUCtau. The metabolites of HMPL-523 were M1 (HM5023222) and M44 (HM5025866) only. The PK parameters were determined by non-compartmental analysis. Eventually, the patients discontinued as they progressed in the study. Hence, fewer patients at each cycle and no patients returned on Cycle 1 Day 28 in dose escalation stage: HMPL-523 800 mg QD and dose expansion stage: MZL arms.
The PKAS included all patients who received at least 1 dose of HMPL-523 and had at least 1 PK sample obtained and analyzed. As pre-specified in the SAP, the results are presented by disease groups and combined data for CLL and CLL-post BTK arms in the dose expansion stage is presented for all patients evaluable for this endpoint who received HMPL-523 at RP2D (700 mg QD) in dose expansion stage. Only patients with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ratio
Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Day 28 of Cycle 1
ID
Title
Description
OG000
Dose Escalation Stage: HMPL-523 100 mg QD
Patients received HMPL-523 100 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Secondary
Dose Escalation Stage and Dose Expansion Stage: Accumulation Ratio for Maximum Plasma Concentration (RA[Cmax]) of HMPL-523
Blood samples were collected to determine RA(Cmax) of HMPL-523. The PK parameters were determined by non-compartmental analysis. Eventually, the patients discontinued as they progressed in the study. Hence, fewer patients at each cycle and no patients returned on Cycle 1 Day 28 in dose expansion stage: MZL arm.
The PKAS included all patients who received at least 1 dose of HMPL-523 and had at least 1 PK sample obtained and analyzed. As pre-specified in the SAP, the results are presented by disease groups and combined data for CLL and CLL-post BTK arms in the dose expansion stage is presented for all patients evaluable for this endpoint who received HMPL-523 at RP2D (700 mg QD) in dose expansion stage. Only patients with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ratio
Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Day 28 of Cycle 1
ID
Title
Description
OG000
Dose Escalation Stage: HMPL-523 100 mg QD
Patients received HMPL-523 100 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG001
Dose Escalation Stage: HMPL-523 200 mg QD
Secondary
Dose Escalation Stage and Dose Expansion Stage: Accumulation Ratio for Area Under the Concentration-Time Curve During a Dosing Interval (RA[AUC]) of HMPL-523
Blood samples were collected to determine RA(AUC) of HMPL-523. The PK parameters were determined by non-compartmental analysis. Eventually, the patients discontinued as they progressed in the study. Hence, fewer patients at each cycle and no patients returned on Cycle 1 Day 28 in dose escalation stage: HMPL-523 800 mg QD and dose expansion stage: MZL arms.
The PKAS included all patients who received at least 1 dose of HMPL-523 and had at least 1 PK sample obtained and analyzed. As pre-specified in the SAP, the results are presented by disease groups and combined data for CLL and CLL-post BTK arms in the dose expansion stage is presented for all patients evaluable for this endpoint who received HMPL-523 at RP2D (700 mg QD) in dose expansion stage. Only patients with data collected at specified timepoints are reported.
Posted
Mean
Standard Deviation
ratio
Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Day 28 of Cycle 1
ID
Title
Description
OG000
Dose Escalation Stage: HMPL-523 100 mg QD
Patients received HMPL-523 100 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG001
Secondary
Dose Expansion Stage: Number of Patients With Treatment-Emergent Adverse Events, Treatment Related Treatment-Emergent Adverse Events, Treatment-Emergent Adverse Events Leading to Treatment Interruption, Treatment Reduction and Treatment Discontinuation
An AE was any untoward medical occurrence in a clinical study patient temporally associated with the use of a study treatment, whether or not considered related to the treatment. TEAEs were defined as AEs with an onset date on or after the first dose of study treatment and no later than 30 days after the date of last study treatment administration or start of a new treatment of anti-neoplasm therapy, whichever was earlier. Treatment related AEs were the TEAEs that were reported as related to study treatment by the Investigator.
The FAS included all patients who received at least 1 dose of HMPL-523.
Posted
Count of Participants
Participants
No
From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months
ID
Title
Description
OG000
Dose Expansion Stage: HL
Patients with HL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG001
Dose Expansion Stage: CLL
Patients with CLL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Secondary
Dose Escalation Stage: Objective Response Rate
ORR: percentage of patients who had BOR with CR, CRi, nPR or PR for CLL patients; CR, VGPR, PR or MR for WM patients; CR or PR for patients with disease type other than CLL and WM. BOR: best response from start of treatment until progression or any further anticancer therapy. CR: absence of S monoclonal IgM, normal S IgM, complete resolution of extramedullary disease, morphologically normal bone marrow aspirate and trephine biopsy. CRi: criteria fulfilled for CR but persistent cytopenia, anemia, thrombocytopenia or neutropenia. nPR: patients with residual CLL cells. PR, VGPR, MR: detectable monoclonal IgM, no new signs/symptoms of active disease and PR: >=50% but <90% reduction in S IgM, reduction in extramedullary disease, VGPR: >=90% reduction in S IgM, complete resolution of extramedullary disease, MR: >=25% but <50% reduction in S IgM.
The RES included all patients who received at least 1 dose of HMPL-523, had a baseline tumor measurement, and had at least 1 post-baseline tumor measurement or clinical restaging, unless death occurred before the first post-baseline assessment.
Posted
Number
95% Confidence Interval
percentage of patients
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months
ID
Title
Description
OG000
Dose Escalation Stage: HMPL-523 100 mg QD
Patients received HMPL-523 100 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Secondary
Dose Escalation Stage: Complete Response Rate
CR rate was defined as the percentage of patients who had BOR with CR or CRi for CLL patients, and CR only for other patients. BOR was defined as the best response from start of treatment until progression or any further anticancer therapy. CR was defined as the absence of serum monoclonal IgM, normal serum IgM, complete resolution of extramedullary disease, morphologically normal bone marrow aspirate and trephine biopsy. CRi was defined as the criteria fulfilled for CR but persistent cytopenia, anemia, thrombocytopenia or neutropenia.
The RES included all patients who received at least 1 dose of HMPL-523, had a baseline tumor measurement, and had at least 1 post-baseline tumor measurement or clinical restaging, unless death occurred before the first post-baseline assessment.
Posted
Number
95% Confidence Interval
percentage of patients
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months
ID
Title
Description
OG000
Dose Escalation Stage: HMPL-523 100 mg QD
Patients received HMPL-523 100 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG001
Dose Escalation Stage: HMPL-523 200 mg QD
Secondary
Dose Escalation Stage: Clinical Benefit Rate
CBR was defined as the percentage of patients who had BOR of SD or better. BOR was defined as the best response from start of treatment until progression or any further anticancer therapy. SD was defined as detectable monoclonal IgM, <25% reduction and <25% increase in serum IgM level, no progression in extramedullary disease, no new signs/symptoms of active disease.
The RES included all patients who received at least 1 dose of HMPL-523, had a baseline tumor measurement, and had at least 1 post-baseline tumor measurement or clinical restaging, unless death occurred before the first post-baseline assessment.
Posted
Number
95% Confidence Interval
percentage of patients
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months
ID
Title
Description
OG000
Dose Escalation Stage: HMPL-523 100 mg QD
Patients received HMPL-523 100 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG001
Dose Escalation Stage: HMPL-523 200 mg QD
Patients received HMPL-523 200 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Secondary
Dose Escalation Stage: Duration of Response
DOR: time from when first response (CR, CRi, PR, nPR, VGPR, PR-L, and MR) was achieved until earlier of first documentation of definitive PD or death from any cause. CR: absence of S monoclonal IgM, normal S IgM, complete resolution of extramedullary disease, morphologically normal bone marrow aspirate and trephine biopsy. CRi: criteria fulfilled for CR but persistent cytopenia, anemia, thrombocytopenia or neutropenia. nPR: patients with residual CLL cells. PR-L: patients achieved PR with CLL-related signs/symptoms other than lymphocytosis and continued on therapy. PR, VGPR, MR: detectable monoclonal IgM, no new signs/symptoms of active disease and PR: >=50% but <90% reduction in S IgM, reduction in extramedullary disease, VGPR: >=90% reduction in S IgM, complete resolution of extramedullary disease, MR: >=25% but <50% reduction in S IgM. PD: >=25% increase in S IgM level from lowest nadir and/or progression in clinical features attributable to disease.
The RES included all patients who received at least 1 dose of HMPL-523, had a baseline tumor measurement, and had at least 1 post-baseline tumor measurement or clinical restaging, unless death occurred before the first post-baseline assessment. Only patients with response of CR, CRi, PR, nPR, VGPR, PR-L, or MR were included in the analysis.
Posted
Median
95% Confidence Interval
months
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months
ID
Title
Description
OG000
Dose Escalation Stage: HMPL-523 100 mg QD
Patients received HMPL-523 100 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Secondary
Dose Escalation Stage: Time to Response
TTR was defined as the time from the first dose of study treatment to the first occurrence of CR, CRi, PR, nPR, VGPR, PR-L, or MR. CR: absence of S monoclonal IgM, normal S IgM, complete resolution of extramedullary disease, morphologically normal bone marrow aspirate and trephine biopsy. CRi: criteria fulfilled for CR but persistent cytopenia, anemia, thrombocytopenia or neutropenia. nPR: patients with residual CLL cells. PR-L: patients achieved PR with CLL-related signs/symptoms other than lymphocytosis and continued on therapy. PR, VGPR, MR: detectable monoclonal IgM, no new signs/symptoms of active disease and PR: >=50% but <90% reduction in S IgM, reduction in extramedullary disease, VGPR: >=90% reduction in S IgM, complete resolution of extramedullary disease, MR: >=25% but <50% reduction in S IgM. Kaplan Meier analysis included only the responders.
The RES included all patients who received at least 1 dose of HMPL-523, had a baseline tumor measurement, and had at least 1 post-baseline tumor measurement or clinical restaging, unless death occurred before the first post-baseline assessment. Only patients with response of CR, CRi, PR, nPR, VGPR, PR-L, or MR were included in the analysis.
Posted
Median
95% Confidence Interval
months
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months
ID
Title
Description
OG000
Dose Escalation Stage: HMPL-523 100 mg QD
Patients received HMPL-523 100 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Secondary
Dose Escalation Stage: Progression-Free Survival
PFS was defined as the time from the date of first study treatment to the earliest date of PD or death due to any reason whichever occurred first. PD was defined as >=25% increase in serum IgM level from lowest nadir and/or progression in clinical features attributable to disease.
The FAS included all patients who received at least 1 dose of HMPL-523.
Posted
Median
95% Confidence Interval
months
Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months
ID
Title
Description
OG000
Dose Escalation Stage: HMPL-523 100 mg QD
Patients received HMPL-523 100 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG001
Dose Escalation Stage: HMPL-523 200 mg QD
Patients received HMPL-523 200 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Time Frame
AEs and SAEs were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months for each stage (dose escalation and dose expansion). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to end of study visit, approximately 65 months.
Description
The FAS included all patients who received at least 1 dose of HMPL-523. SAEs: AEs that resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Other AEs: An AE that was not serious and exceeded a frequency threshold of 5% within any cohort of the study.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Dose Escalation Stage: HMPL-523 100 mg QD
Patients received HMPL-523 100 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
0
4
1
4
4
4
EG001
Dose Escalation Stage: HMPL-523 200 mg QD
Patients received HMPL-523 200 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
0
3
2
3
3
3
EG002
Dose Escalation Stage: HMPL-523 400 mg QD
Patients received HMPL-523 400 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
0
3
1
3
3
3
EG003
Dose Escalation Stage: HMPL-523 600 mg QD
Patients received HMPL-523 600 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
0
3
1
3
3
3
EG004
Dose Escalation Stage: HMPL-523 700 mg QD
Patients received HMPL-523 700 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
0
4
0
4
4
4
EG005
Dose Escalation Stage: HMPL-523 800 mg QD
Patients received HMPL-523 800 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
1
4
3
4
4
4
EG006
Dose Expansion Stage: HL
Patients with HL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
2
25
6
25
25
25
EG007
Dose Expansion Stage: CLL
Patients with CLL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
0
1
0
1
0
1
EG008
Dose Expansion Stage: CLL-post BTK
Patients with CLL-post BTK received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
1
7
4
7
7
7
EG009
Dose Expansion Stage: FL
Patients with FL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
0
2
2
2
2
2
EG010
Dose Expansion Stage: MZL
Patients with MZL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
0
1
0
1
1
1
EG011
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
0
1
1
1
1
1
EG012
Dose Expansion Stage: MCL
Patients with MCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
1
2
0
2
2
2
EG013
Dose Expansion Stage: PTCL
Patients with PTCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
3
9
5
9
9
9
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
Enterocolitis infectious
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Intestinal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Atrial tachycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abortion spontaneous complete
Pregnancy, puerperium and perinatal conditions
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Chorioretinitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Herpes simplex reactivation
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Stenotrophomonas infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Disease progression
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pyrexia
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0032 events2 affected3 at risk
EG0040 events0 affected4 at risk
EG0052 events2 affected4 at risk
EG0066 events4 affected25 at risk
EG0070 events0 affected1 at risk
EG0084 events3 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0121 events1 affected2 at risk
EG0131 events1 affected9 at risk
Asthenia
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Axillary pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Chills
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Gait disturbance
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Generalised oedema
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Suprapubic pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Amylase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lipase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood urea decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected4 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Microcytic anaemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Seizure
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection enterococcal
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cytomegalovirus infection reactivation
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Renal tubular disorder
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Yellow skin
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypogonadism
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Biliary colic
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
The study was terminated based on strategic decision made by the Sponsor to discontinue development of HMPL-523 for lymphoma in the United States, Europe, and Australia with no safety concerns.
Patients received HMPL-523 800 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
3
OG0043
OG0054
0
OG0040
OG0052
OG002
Dose Escalation Stage: HMPL-523 400 mg QD
Patients received HMPL-523 400 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Escalation Stage: HMPL-523 600 mg QD
Patients received HMPL-523 600 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Escalation Stage: HMPL-523 700 mg QD
Patients received HMPL-523 700 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG005
Dose Escalation Stage: HMPL-523 800 mg QD
Patients received HMPL-523 800 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0033
OG0044
OG0054
Title
Denominators
Categories
Any TEAE
Title
Measurements
OG0004
OG0013
OG0023
OG0033
OG0044
OG0054
Any Treatment related TEAE
Title
Measurements
OG0003
OG0013
OG0023
OG003
Any TEAE leading to treatment interruption
Title
Measurements
OG0001
OG0012
OG0021
OG003
Any TEAE leading to treatment reduction
Title
Measurements
OG0000
OG0010
OG0020
OG003
Any TEAE leading to treatment discontinuation
Title
Measurements
OG0000
OG0010
OG0020
OG003
21
Title
Denominators
Categories
Title
Measurements
OG000700
OG001
Dose Expansion Stage: CLL
Patients with CLL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG002
Dose Expansion Stage: CLL-post BTK
Patients with CLL-post BTK received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Expansion Stage: FL
Patients with FL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Expansion Stage: MZL
Patients with MZL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG005
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG006
Dose Expansion Stage: MCL
Patients with MCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG007
Dose Expansion Stage: PTCL
Patients with PTCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG00025
OG0011
OG0027
OG0032
OG0041
OG0051
OG0061
OG0078
Title
Denominators
Categories
Title
Measurements
OG00024.0(9.4 to 45.1)
OG001100(2.5 to 100.0)
OG00228.6(3.7 to 71.0)
OG0030(0.0 to 84.2)
OG0040(0.0 to 97.5)
OG005100(2.5 to 100.0)
OG0060(0.0 to 97.5)
OG00737.5(8.5 to 75.5)
Patients with CLL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG002
Dose Expansion Stage: CLL-post BTK
Patients with CLL-post BTK received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Expansion Stage: FL
Patients with FL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Expansion Stage: MZL
Patients with MZL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG005
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG006
Dose Expansion Stage: MCL
Patients with MCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG007
Dose Expansion Stage: PTCL
Patients with PTCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG00025
OG0011
OG0027
OG0032
OG0041
OG0051
OG0061
OG0078
Title
Denominators
Categories
Title
Measurements
OG0008.0(1.0 to 26.0)
OG001100(2.5 to 100.0)
OG0020(0.0 to 41.0)
OG0030(0.0 to 84.2)
OG0040(0.0 to 97.5)
OG0050(0.0 to 97.5)
OG0060(0.0 to 97.5)
OG00725.0(3.2 to 65.1)
OG002
Dose Expansion Stage: CLL-post BTK
Patients with CLL-post BTK received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Expansion Stage: FL
Patients with FL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Expansion Stage: MZL
Patients with MZL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG005
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG006
Dose Expansion Stage: MCL
Patients with MCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG007
Dose Expansion Stage: PTCL
Patients with PTCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG00025
OG0011
OG0027
OG0032
OG0041
OG0051
OG0061
OG0078
Title
Denominators
Categories
Title
Measurements
OG00064.0(42.5 to 82.0)
OG001100(2.5 to 100.0)
OG00271.4(29.0 to 96.3)
OG003100(15.8 to 100.0)
OG004100(2.5 to 100.0)
OG005100(2.5 to 100.0)
OG0060(0.0 to 97.5)
OG00737.5(8.5 to 75.5)
OG001
Dose Expansion Stage: CLL
Patients with CLL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG002
Dose Expansion Stage: CLL-post BTK
Patients with CLL-post BTK received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Expansion Stage: FL
Patients with FL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Expansion Stage: MZL
Patients with MZL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG005
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG006
Dose Expansion Stage: MCL
Patients with MCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG007
Dose Expansion Stage: PTCL
Patients with PTCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0006
OG0011
OG0022
OG0030
OG0040
OG0051
OG0060
OG0073
Title
Denominators
Categories
Title
Measurements
OG0006.7(1.9 to NA)NA indicates that upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of patients with events at study termination.
OG001NA(NA to NA)NA indicates that median, upper and lower limits of 95% CI were not estimable due to insufficient number of patients with events at study termination.
OG00211.3(10.6 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG005NA(NA to NA)NA indicates that median, upper and lower limits of 95% CI were not estimable due to insufficient number of patients with events at study termination.
OG0075.7(2.0 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG001
Dose Expansion Stage: CLL
Patients with CLL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG002
Dose Expansion Stage: CLL-post BTK
Patients with CLL-post BTK received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Expansion Stage: FL
Patients with FL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Expansion Stage: MZL
Patients with MZL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG005
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG006
Dose Expansion Stage: MCL
Patients with MCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG007
Dose Expansion Stage: PTCL
Patients with PTCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0006
OG0011
OG0022
OG0030
OG0040
OG0051
OG0060
OG0073
Title
Denominators
Categories
Title
Measurements
OG0001.9(1.4 to NA)NA indicates that upper limit of 95% CI for the median was not estimable because the 95% Kaplan Meier confidence band for the survival function did not cross 0.5.
OG00124.8(NA to NA)NA indicates that upper and lower limits of 95% CI were not estimable for only 1 patient.
OG0021.8(1.7 to NA)NA indicates that upper limit of 95% CI for the median was not estimable because the 95% Kaplan Meier confidence band for the survival function did not cross 0.5.
OG0056.1(NA to NA)NA indicates that upper and lower limits of 95% CI were not estimable for only 1 patient.
OG0071.8(1.4 to NA)NA indicates that upper limit of 95% CI for the median was not estimable because the 95% Kaplan Meier confidence band for the survival function did not cross 0.5.
OG002
Dose Expansion Stage: CLL-post BTK
Patients with CLL-post BTK received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Expansion Stage: FL
Patients with FL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Expansion Stage: MZL
Patients with MZL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG005
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG006
Dose Expansion Stage: MCL
Patients with MCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG007
Dose Expansion Stage: PTCL
Patients with PTCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG00025
OG0011
OG0027
OG0032
OG0041
OG0051
OG0062
OG0079
Title
Denominators
Categories
Title
Measurements
OG0003.6(1.7 to 4.8)
OG001NA(NA to NA)NA indicates that median, upper and lower limits of 95% CI were not estimable due to insufficient number of patients with events at study termination.
OG00212.3(1.7 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG003NA(NA to NA)NA indicates that median, upper and lower limits of 95% CI were not estimable due to insufficient number of patients with events at study termination.
OG0045.1(NA to NA)NA indicates that upper and lower limits of 95% CI were not estimable for only 1 patient.
OG005NA(NA to NA)NA indicates that median, upper and lower limits of 95% CI were not estimable due to insufficient number of patients with events at study termination.
OG0061.4(NA to NA)NA indicates that upper and lower limits of 95% CI were not estimable as there were insufficient numbers of patients with events and/or censoring at the time of analysis.
OG0071.8(0.8 to 7.2)
Patients received HMPL-523 200 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG002
Dose Escalation Stage: HMPL-523 400 mg QD
Patients received HMPL-523 400 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Escalation Stage: HMPL-523 600 mg QD
Patients received HMPL-523 600 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Escalation Stage: HMPL-523 700 mg QD
Patients received HMPL-523 700 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG005
Dose Escalation Stage: HMPL-523 800 mg QD
Patients received HMPL-523 800 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG006
Dose Expansion Stage: HL
Patients with HL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG007
Dose Expansion Stage: CLL and CLL-post BTK
Patients with CLL and CLL-post BTK received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG008
Dose Expansion Stage: FL
Patients with FL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG009
Dose Expansion Stage: MZL
Patients with MZL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG010
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG011
Dose Expansion Stage: MCL
Patients with MCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG012
Dose Expansion Stage: PTCL
Patients with PTCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0033
OG0044
OG0054
OG00623
OG0077
OG0082
OG0091
OG0101
OG0112
OG0129
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0044
ParticipantsOG0054
ParticipantsOG00623
ParticipantsOG0077
ParticipantsOG0082
ParticipantsOG0091
ParticipantsOG0101
ParticipantsOG0112
ParticipantsOG0129
Title
Measurements
OG00036.43± 33.98
OG00151.93± 10.45
OG00258.00± 19.24
OG003
Cycle 1 Day 15
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 1 Day 28
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Patients received HMPL-523 200 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG002
Dose Escalation Stage: HMPL-523 400 mg QD
Patients received HMPL-523 400 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Escalation Stage: HMPL-523 600 mg QD
Patients received HMPL-523 600 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Escalation Stage: HMPL-523 700 mg QD
Patients received HMPL-523 700 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG005
Dose Escalation Stage: HMPL-523 800 mg QD
Patients received HMPL-523 800 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG006
Dose Expansion Stage: HL
Patients with HL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG007
Dose Expansion Stage: CLL and CLL-post BTK
Patients with CLL and CLL-post BTK received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG008
Dose Expansion Stage: FL
Patients with FL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG009
Dose Expansion Stage: MZL
Patients with MZL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG010
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG011
Dose Expansion Stage: MCL
Patients with MCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG012
Dose Expansion Stage: PTCL
Patients with PTCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0033
OG0044
OG0054
OG00623
OG0077
OG0082
OG0091
OG0101
OG0112
OG0129
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0044
ParticipantsOG0054
ParticipantsOG00623
ParticipantsOG0077
ParticipantsOG0082
ParticipantsOG0091
ParticipantsOG0101
ParticipantsOG0112
ParticipantsOG0129
Title
Measurements
OG0005.84(2.00 to 6.00)
OG0015.92(4.00 to 5.98)
OG0025.80(4.02 to 7.75)
OG003
Cycle 1 Day 15
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 1 Day 28
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
OG002
Dose Escalation Stage: HMPL-523 400 mg QD
Patients received HMPL-523 400 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Escalation Stage: HMPL-523 600 mg QD
Patients received HMPL-523 600 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Escalation Stage: HMPL-523 700 mg QD
Patients received HMPL-523 700 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG005
Dose Escalation Stage: HMPL-523 800 mg QD
Patients received HMPL-523 800 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG006
Dose Expansion Stage: HL
Patients with HL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG007
Dose Expansion Stage: CLL and CLL-post BTK
Patients with CLL and CLL-post BTK received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG008
Dose Expansion Stage: FL
Patients with FL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG009
Dose Expansion Stage: MZL
Patients with MZL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG010
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG011
Dose Expansion Stage: MCL
Patients with MCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG012
Dose Expansion Stage: PTCL
Patients with PTCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0033
OG0044
OG0054
OG00620
OG0077
OG0082
OG0091
OG0101
OG0112
OG0129
Title
Denominators
Categories
Title
Measurements
OG000352.3± 247.5
OG001589.1± 77.22
OG002734.1± 195.0
OG0031278± 50.63
OG0041608± 469.1
OG0052624± 1244
OG0061771± 864.5
OG0071568± 676.6
OG008NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG009NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG010NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG011NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG0121622± 686.5
Patients received HMPL-523 200 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG002
Dose Escalation Stage: HMPL-523 400 mg QD
Patients received HMPL-523 400 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Escalation Stage: HMPL-523 600 mg QD
Patients received HMPL-523 600 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Escalation Stage: HMPL-523 700 mg QD
Patients received HMPL-523 700 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG005
Dose Escalation Stage: HMPL-523 800 mg QD
Patients received HMPL-523 800 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG006
Dose Expansion Stage: HL
Patients with HL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG007
Dose Expansion Stage: CLL and CLL-post BTK
Patients with CLL and CLL-post BTK received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG008
Dose Expansion Stage: FL
Patients with FL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG009
Dose Expansion Stage: MZL
Patients with MZL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG010
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG011
Dose Expansion Stage: MCL
Patients with MCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG012
Dose Expansion Stage: PTCL
Patients with PTCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0033
OG0044
OG0054
OG00619
OG0077
OG0082
OG0091
OG0101
OG0112
OG0129
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0044
ParticipantsOG0054
ParticipantsOG00619
ParticipantsOG0077
ParticipantsOG0082
ParticipantsOG0091
ParticipantsOG0101
ParticipantsOG0112
ParticipantsOG0129
Title
Measurements
OG000352.3± 247.5
OG001589.1± 77.22
OG002NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG003
Cycle 1 Day 15
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0033
Cycle 1 Day 28
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0032
Patients received HMPL-523 200 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG002
Dose Escalation Stage: HMPL-523 400 mg QD
Patients received HMPL-523 400 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Escalation Stage: HMPL-523 600 mg QD
Patients received HMPL-523 600 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Escalation Stage: HMPL-523 700 mg QD
Patients received HMPL-523 700 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG005
Dose Escalation Stage: HMPL-523 800 mg QD
Patients received HMPL-523 800 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG006
Dose Expansion Stage: HL
Patients with HL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG007
Dose Expansion Stage: CLL and CLL-post BTK
Patients with CLL and CLL-post BTK received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG008
Dose Expansion Stage: FL
Patients with FL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG009
Dose Expansion Stage: MZL
Patients with MZL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG010
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG011
Dose Expansion Stage: MCL
Patients with MCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG012
Dose Expansion Stage: PTCL
Patients with PTCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0033
OG0043
OG0051
OG00618
OG0076
OG0081
OG0090
OG0101
OG0111
OG0126
Title
Denominators
Categories
Cycle 1 Day 15
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000249.3± 101.3
OG001NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG002313.3± 85.63
OG003
Cycle 1 Day 28
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0032
Patients received HMPL-523 200 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG002
Dose Escalation Stage: HMPL-523 400 mg QD
Patients received HMPL-523 400 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Escalation Stage: HMPL-523 600 mg QD
Patients received HMPL-523 600 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Escalation Stage: HMPL-523 700 mg QD
Patients received HMPL-523 700 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG005
Dose Escalation Stage: HMPL-523 800 mg QD
Patients received HMPL-523 800 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG006
Dose Expansion Stage: HL
Patients with HL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG007
Dose Expansion Stage: CLL and CLL-post BTK
Patients with CLL and CLL-post BTK received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG008
Dose Expansion Stage: FL
Patients with FL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG009
Dose Expansion Stage: MZL
Patients with MZL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG010
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG011
Dose Expansion Stage: MCL
Patients with MCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG012
Dose Expansion Stage: PTCL
Patients with PTCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0033
OG0043
OG0051
OG00619
OG0076
OG0081
OG0090
OG0101
OG0111
OG0126
Title
Denominators
Categories
Cycle 1 Day 15
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG00011.07± 6.639
OG00110.64± 3.688
OG00226.17± 11.35
OG003
Cycle 1 Day 28
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Patients received HMPL-523 200 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG002
Dose Escalation Stage: HMPL-523 400 mg QD
Patients received HMPL-523 400 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Escalation Stage: HMPL-523 600 mg QD
Patients received HMPL-523 600 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Escalation Stage: HMPL-523 700 mg QD
Patients received HMPL-523 700 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG005
Dose Escalation Stage: HMPL-523 800 mg QD
Patients received HMPL-523 800 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG006
Dose Expansion Stage: HL
Patients with HL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG007
Dose Expansion Stage: CLL and CLL-post BTK
Patients with CLL and CLL-post BTK received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG008
Dose Expansion Stage: FL
Patients with FL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG009
Dose Expansion Stage: MZL
Patients with MZL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG010
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG011
Dose Expansion Stage: MCL
Patients with MCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG012
Dose Expansion Stage: PTCL
Patients with PTCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0033
OG0043
OG0051
OG00619
OG0076
OG0081
OG0090
OG0101
OG0111
OG0126
Title
Denominators
Categories
M1: Cycle 1 Day 15
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0000.5991± 0.2933
OG0010.7537± 0.4587
OG0020.7159± 0.3763
OG003
M1: Cycle 1 Day 28
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
M44: Cycle 1 Day 15
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
M44: Cycle 1 Day 28
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
OG001
Dose Escalation Stage: HMPL-523 200 mg QD
Patients received HMPL-523 200 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG002
Dose Escalation Stage: HMPL-523 400 mg QD
Patients received HMPL-523 400 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Escalation Stage: HMPL-523 600 mg QD
Patients received HMPL-523 600 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Escalation Stage: HMPL-523 700 mg QD
Patients received HMPL-523 700 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG005
Dose Escalation Stage: HMPL-523 800 mg QD
Patients received HMPL-523 800 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG006
Dose Expansion Stage: HL
Patients with HL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG007
Dose Expansion Stage: CLL and CLL-post BTK
Patients with CLL and CLL-post BTK received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG008
Dose Expansion Stage: FL
Patients with FL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG009
Dose Expansion Stage: MZL
Patients with MZL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG010
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG011
Dose Expansion Stage: MCL
Patients with MCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG012
Dose Expansion Stage: PTCL
Patients with PTCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0033
OG0043
OG0051
OG00618
OG0076
OG0081
OG0090
OG0101
OG0111
OG0126
Title
Denominators
Categories
M1: Cycle 1 Day 15
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0000.6036± 0.2634
OG001NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG0020.6525± 0.3439
OG003
M1: Cycle 1 Day 28
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0032
M44: Cycle 1 Day 15
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0033
M44: Cycle 1 Day 28
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0032
Patients received HMPL-523 200 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG002
Dose Escalation Stage: HMPL-523 400 mg QD
Patients received HMPL-523 400 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Escalation Stage: HMPL-523 600 mg QD
Patients received HMPL-523 600 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Escalation Stage: HMPL-523 700 mg QD
Patients received HMPL-523 700 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG005
Dose Escalation Stage: HMPL-523 800 mg QD
Patients received HMPL-523 800 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG006
Dose Expansion Stage: HL
Patients with HL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG007
Dose Expansion Stage: CLL and CLL-post BTK
Patients with CLL and CLL-post BTK received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG008
Dose Expansion Stage: FL
Patients with FL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG009
Dose Expansion Stage: MZL
Patients with MZL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG010
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG011
Dose Expansion Stage: MCL
Patients with MCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG012
Dose Expansion Stage: PTCL
Patients with PTCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0033
OG0043
OG0051
OG00618
OG0075
OG0081
OG0090
OG0101
OG0111
OG0126
Title
Denominators
Categories
Cycle 1 Day 15
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0001.187± 0.5408
OG0011.020± 0.1992
OG0022.126± 0.7567
OG003
Cycle 1 Day 28
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Dose Escalation Stage: HMPL-523 200 mg QD
Patients received HMPL-523 200 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG002
Dose Escalation Stage: HMPL-523 400 mg QD
Patients received HMPL-523 400 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Escalation Stage: HMPL-523 600 mg QD
Patients received HMPL-523 600 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Escalation Stage: HMPL-523 700 mg QD
Patients received HMPL-523 700 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG005
Dose Escalation Stage: HMPL-523 800 mg QD
Patients received HMPL-523 800 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG006
Dose Expansion Stage: HL
Patients with HL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG007
Dose Expansion Stage: CLL and CLL-post BTK
Patients with CLL and CLL-post BTK received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG008
Dose Expansion Stage: FL
Patients with FL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG009
Dose Expansion Stage: MZL
Patients with MZL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG010
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG011
Dose Expansion Stage: MCL
Patients with MCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG012
Dose Expansion Stage: PTCL
Patients with PTCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0004
OG0013
OG0022
OG0033
OG0043
OG0051
OG00614
OG0075
OG0081
OG0090
OG0101
OG0111
OG0126
Title
Denominators
Categories
Cycle 1 Day 15
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0001.590± 0.8423
OG001NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG002NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG003
Cycle 1 Day 28
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0032
OG002
Dose Expansion Stage: CLL-post BTK
Patients with CLL-post BTK received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Expansion Stage: FL
Patients with FL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Expansion Stage: MZL
Patients with MZL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG005
Dose Expansion Stage: LPL/WM
Patients with LPL/WM received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG006
Dose Expansion Stage: MCL
Patients with MCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG007
Dose Expansion Stage: PTCL
Patients with PTCL received HMPL-523 700 mg (RP2D) tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG00025
OG0011
OG0027
OG0032
OG0041
OG0051
OG0062
OG0079
Title
Denominators
Categories
Any TEAE
Title
Measurements
OG00025
OG0010
OG0027
OG0032
OG0041
OG0051
OG0062
OG0079
Any Treatment related TEAE
Title
Measurements
OG00019
OG0010
OG0026
OG003
Any TEAE leading to treatment interruption
Title
Measurements
OG00012
OG0010
OG0026
OG003
Any TEAE leading to treatment reduction
Title
Measurements
OG0000
OG0010
OG0024
OG003
Any TEAE leading to treatment discontinuation
Title
Measurements
OG0000
OG0010
OG0021
OG003
OG001
Dose Escalation Stage: HMPL-523 200 mg QD
Patients received HMPL-523 200 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG002
Dose Escalation Stage: HMPL-523 400 mg QD
Patients received HMPL-523 400 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Escalation Stage: HMPL-523 600 mg QD
Patients received HMPL-523 600 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Escalation Stage: HMPL-523 700 mg QD
Patients received HMPL-523 700 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG005
Dose Escalation Stage: HMPL-523 800 mg QD
Patients received HMPL-523 800 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0004
OG0013
OG0022
OG0033
OG0043
OG0054
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 70.8)
OG00250.0(1.3 to 98.7)
OG00333.3(0.8 to 90.6)
OG00433.3(0.8 to 90.6)
OG00550.0(6.8 to 93.2)
Patients received HMPL-523 200 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG002
Dose Escalation Stage: HMPL-523 400 mg QD
Patients received HMPL-523 400 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Escalation Stage: HMPL-523 600 mg QD
Patients received HMPL-523 600 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Escalation Stage: HMPL-523 700 mg QD
Patients received HMPL-523 700 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG005
Dose Escalation Stage: HMPL-523 800 mg QD
Patients received HMPL-523 800 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0004
OG0013
OG0022
OG0033
OG0043
OG0054
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 70.8)
OG0020(0.0 to 84.2)
OG00333.3(0.8 to 90.6)
OG0040(0.0 to 70.8)
OG00550.0(6.8 to 93.2)
OG002
Dose Escalation Stage: HMPL-523 400 mg QD
Patients received HMPL-523 400 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Escalation Stage: HMPL-523 600 mg QD
Patients received HMPL-523 600 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Escalation Stage: HMPL-523 700 mg QD
Patients received HMPL-523 700 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG005
Dose Escalation Stage: HMPL-523 800 mg QD
Patients received HMPL-523 800 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0004
OG0013
OG0022
OG0033
OG0043
OG0054
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 70.8)
OG002100(15.8 to 100.0)
OG00366.7(9.4 to 99.2)
OG00433.3(0.8 to 90.6)
OG00550.0(6.8 to 93.2)
OG001
Dose Escalation Stage: HMPL-523 200 mg QD
Patients received HMPL-523 200 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG002
Dose Escalation Stage: HMPL-523 400 mg QD
Patients received HMPL-523 400 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Escalation Stage: HMPL-523 600 mg QD
Patients received HMPL-523 600 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Escalation Stage: HMPL-523 700 mg QD
Patients received HMPL-523 700 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG005
Dose Escalation Stage: HMPL-523 800 mg QD
Patients received HMPL-523 800 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0000
OG0010
OG0021
OG0031
OG0041
OG0052
Title
Denominators
Categories
Title
Measurements
OG00215.7(NA to NA)NA indicates that upper and lower limits of 95% CI were not estimable for only 1 patient.
OG00325.9(NA to NA)NA indicates that upper and lower limits of 95% CI were not estimable for only 1 patient.
OG004NA(NA to NA)NA indicates that median, upper and lower limits of 95% CI were not estimable due to insufficient number of patients with events at study termination.
OG005NA(NA to NA)NA indicates that median, upper and lower limits of 95% CI were not estimable due to insufficient number of patients with events at study termination.
OG001
Dose Escalation Stage: HMPL-523 200 mg QD
Patients received HMPL-523 200 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG002
Dose Escalation Stage: HMPL-523 400 mg QD
Patients received HMPL-523 400 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Escalation Stage: HMPL-523 600 mg QD
Patients received HMPL-523 600 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Escalation Stage: HMPL-523 700 mg QD
Patients received HMPL-523 700 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG005
Dose Escalation Stage: HMPL-523 800 mg QD
Patients received HMPL-523 800 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0000
OG0010
OG0021
OG0031
OG0041
OG0052
Title
Denominators
Categories
Title
Measurements
OG0026.7(NA to NA)NA indicates that upper and lower limits of 95% CI were not estimable for only 1 patient.
OG0031.6(NA to NA)NA indicates that upper and lower limits of 95% CI were not estimable for only 1 patient.
OG0041.6(NA to NA)NA indicates that upper and lower limits of 95% CI were not estimable for only 1 patient.
OG0055.2(1.1 to NA)NA indicates that upper limit of 95% CI for the median was not estimable because the 95% Kaplan Meier confidence band for the survival function did not cross 0.5.
OG002
Dose Escalation Stage: HMPL-523 400 mg QD
Patients received HMPL-523 400 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG003
Dose Escalation Stage: HMPL-523 600 mg QD
Patients received HMPL-523 600 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG004
Dose Escalation Stage: HMPL-523 700 mg QD
Patients received HMPL-523 700 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
OG005
Dose Escalation Stage: HMPL-523 800 mg QD
Patients received HMPL-523 800 mg tablet orally QD from Cycle 1 Day 1 until PD, intolerable toxicity, investigator's discretion of no benefit from the study treatment, withdrawal from the study, the end of the study, or death; whichever occurred first. Each cycle duration was 28 days.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0033
OG0044
OG0054
Title
Denominators
Categories
Title
Measurements
OG0001.3(1.3 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG0011.6(1.0 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG00212.9(3.5 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG00314.7(1.9 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG0041.9(1.7 to NA)NA indicates that upper limit of 95% CI was not estimable due to insufficient number of patients with events at study termination.
OG005NA(0.9 to NA)NA indicates that median and upper limit of 95% CI were not estimable due to insufficient number of patients with events at study termination.
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected2 at risk
EG0100 events0 affected1 at risk
EG0111 events1 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0131 events1 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
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EG0041 events1 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0052 events1 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0062 events2 affected25 at risk
EG0070 events0 affected1 at risk
EG0084 events3 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0131 events1 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected25 at risk
EG0070 events0 affected1 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected2 at risk
EG0101 events1 affected1 at risk
EG0110 events0 affected1 at risk
EG0121 events1 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected25 at risk
EG0070 events0 affected1 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0131 events1 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0064 events4 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected4 at risk
EG0062 events2 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0101 events1 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0131 events1 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
2 events
1 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0052 events1 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected25 at risk
EG0070 events0 affected1 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected2 at risk
EG0101 events1 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0131 events1 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected9 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0063 events2 affected25 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected2 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected1 at risk
EG0121 events1 affected2 at risk
EG0130 events0 affected9 at risk
3
OG0043
OG0053
2
OG0042
OG0052
0
OG0040
OG0053
0
OG0041
OG0052
109.3
± 11.55
OG004126.3± 45.55
OG005208.5± 115.9
OG006173.1± 106.5
OG007131.8± 61.33
OG008NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the statistical analysis plan (SAP).
OG009NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG010NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG011NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG012150.0± 71.30
Participants
OG004
3
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG00032.53± 14.00
OG00152.27± 10.90
OG002118.1± 49.25
OG003233.7± 42.83
OG004218.0± 37.16
OG005NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
Participants
OG004
3
ParticipantsOG0051
ParticipantsOG00619
ParticipantsOG0076
ParticipantsOG0081
ParticipantsOG0090
ParticipantsOG0101
ParticipantsOG0111
ParticipantsOG0126
Title
Measurements
OG00036.10± 13.08
OG00152.70± 12.30
OG002104.7± 19.55
OG003169.3± 67.28
OG004249.7± 59.72
OG005NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG006229.0± 113.7
OG007195.5± 153.6
OG008NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG010NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG011NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG012240.7± 84.51
3.83
(1.07 to 7.75)
OG0044.09(4.00 to 6.00)
OG0056.02(1.00 to 6.05)
OG0064.00(1.00 to 6.03)
OG0072.17(1.00 to 6.00)
OG008NA(1.98 to 4.17)NA indicates that median was not estimated and range is presented for n\<3, as pre-specified in SAP.
OG009NA(23.50 to 23.50)NA indicates that median was not estimated and range is presented for n\<3, as pre-specified in SAP.
OG010NA(4.00 to 4.00)NA indicates that median was not estimated and range is presented for n\<3, as pre-specified in SAP.
OG011NA(4.00 to 4.00)NA indicates that median was not estimated and range is presented for n\<3, as pre-specified in SAP.
OG0124.00(2.00 to 7.52)
Participants
OG004
3
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0005.00(2.00 to 7.83)
OG0014.98(2.00 to 6.00)
OG0023.90(2.02 to 5.92)
OG0033.98(1.95 to 4.00)
OG0044.22(4.08 to 5.83)
OG005NA(6.00 to 6.00)NA indicates that median was not estimated and range is presented for n\<3, as pre-specified in SAP.
Participants
OG004
3
ParticipantsOG0051
ParticipantsOG00619
ParticipantsOG0076
ParticipantsOG0081
ParticipantsOG0090
ParticipantsOG0101
ParticipantsOG0111
ParticipantsOG0126
Title
Measurements
OG0005.92(4.00 to 8.00)
OG0016.00(4.08 to 6.02)
OG0024.00(2.00 to 6.12)
OG0034.20(2.02 to 6.00)
OG0045.78(3.98 to 5.98)
OG005NA(1.83 to 1.83)NA indicates that median was not estimated and range is presented for n\<3, as pre-specified in SAP.
OG0064.03(2.00 to 7.97)
OG0074.93(2.08 to 24.17)
OG008NA(6.17 to 6.17)NA indicates that median was not estimated and range is presented for n\<3, as pre-specified in SAP.
OG010NA(8.00 to 8.00)NA indicates that median was not estimated and range is presented for n\<3, as pre-specified in SAP.
OG011NA(2.00 to 2.00)NA indicates that median was not estimated and range is presented for n\<3, as pre-specified in SAP.
OG0124.10(4.00 to 25.33)
1278
± 50.63
OG0041608± 469.1
OG0052624± 1244
OG0061759± 886.3
OG0071568± 43.1
OG008NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG009NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG010NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG011NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG0121622± 686.5
Participants
OG004
3
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000457.4± 184.9
OG001NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG0021346± 382.8
OG0032618± 864.3
OG0043291± 679.7
OG005NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
Participants
OG004
3
ParticipantsOG0050
ParticipantsOG00618
ParticipantsOG0076
ParticipantsOG0081
ParticipantsOG0090
ParticipantsOG0101
ParticipantsOG0111
ParticipantsOG0126
Title
Measurements
OG000562.5± 193.4
OG001765.1± 150.9
OG0021298± 341.2
OG003NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG0043832± 1080
OG0063324± 1735
OG0072848± 1929
OG008NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG010NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG011NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG0123621± 1273
247.8
± 86.15
OG004219.8± 51.17
OG005NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
Participants
OG004
3
ParticipantsOG0050
ParticipantsOG00618
ParticipantsOG0076
ParticipantsOG0081
ParticipantsOG0090
ParticipantsOG0101
ParticipantsOG0111
ParticipantsOG0126
Title
Measurements
OG000190.8± 56.92
OG001269.2± 59.18
OG002321.2± 74.49
OG003NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG004194.9± 65.24
OG006275.0± 142.3
OG007360.9± 220.8
OG008NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG010NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG011NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG012213.1± 71.20
39.44
± 39.48
OG00460.90± 18.07
OG005NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
Participants
OG004
3
ParticipantsOG0050
ParticipantsOG00619
ParticipantsOG0076
ParticipantsOG0081
ParticipantsOG0090
ParticipantsOG0101
ParticipantsOG0111
ParticipantsOG0126
Title
Measurements
OG00010.51± 2.327
OG00112.23± 1.102
OG00230.10± 17.30
OG00340.10± 27.92
OG00465.80± 24.68
OG00666.09± 45.04
OG00760.40± 42.23
OG008NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG010NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG011NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG01262.23± 22.62
0.5895
± 0.1236
OG0040.8991± 0.3522
OG005NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
ParticipantsOG0043
ParticipantsOG0051
ParticipantsOG00619
ParticipantsOG0076
ParticipantsOG0081
ParticipantsOG0090
ParticipantsOG0101
ParticipantsOG0111
ParticipantsOG0126
Title
Measurements
OG0000.4787± 0.2675
OG0010.5856± 0.1012
OG0020.7050± 0.4432
OG0030.6903± 0.04638
OG0040.8849± 0.3142
OG005NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG0060.7690± 0.3010
OG0070.6421± 0.2987
OG008NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG010NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG011NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG0120.5671± 0.3079
ParticipantsOG0043
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0000.8269± 0.6184
OG0010.5329± 0.3303
OG0020.3375± 0.2551
OG0030.2984± 0.08007
OG0040.1643± 0.02048
OG005NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
ParticipantsOG0043
ParticipantsOG0051
ParticipantsOG00619
ParticipantsOG0076
ParticipantsOG0081
ParticipantsOG0090
ParticipantsOG0101
ParticipantsOG0111
ParticipantsOG0126
Title
Measurements
OG0001.348± 1.066
OG0010.6394± 0.4393
OG0020.2326± 0.1265
OG0030.3579± 0.1291
OG0040.1981± 0.08459
OG005NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG0060.3582± 0.3226
OG0070.5167± 0.4552
OG008NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG010NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG011NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG0120.6787± 0.8715
0.5678
± 0.08923
OG0040.7382± 0.2924
OG005NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
ParticipantsOG0043
ParticipantsOG0050
ParticipantsOG00618
ParticipantsOG0076
ParticipantsOG0081
ParticipantsOG0090
ParticipantsOG0101
ParticipantsOG0111
ParticipantsOG0126
Title
Measurements
OG0000.5254± 0.2937
OG0010.6092± 0.1196
OG0020.6441± 0.3541
OG003NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG0040.7391± 0.2139
OG0060.7104± 0.2589
OG0070.5776± 0.2271
OG008NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG010NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG011NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG0120.5219± 0.2584
ParticipantsOG0043
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG0000.3717± 0.2715
OG001NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG0020.1610± 0.1124
OG0030.1691± 0.06730
OG0040.08454± 0.03028
OG005NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
ParticipantsOG0043
ParticipantsOG0050
ParticipantsOG00618
ParticipantsOG0076
ParticipantsOG0081
ParticipantsOG0090
ParticipantsOG0101
ParticipantsOG0111
ParticipantsOG0126
Title
Measurements
OG0000.5559± 0.5738
OG0010.2030± 0.06731
OG0020.1573± 0.1300
OG003NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG0040.09547± 0.03969
OG0060.2145± 0.1807
OG0070.2147± 0.1247
OG008NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG010NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG011NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG0120.2864± 0.2716
2.151
± 0.4241
OG0041.468± 0.2829
OG005NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
Participants
OG004
3
ParticipantsOG0051
ParticipantsOG00618
ParticipantsOG0075
ParticipantsOG0081
ParticipantsOG0090
ParticipantsOG0101
ParticipantsOG0111
ParticipantsOG0126
Title
Measurements
OG0001.579± 1.148
OG0011.065± 0.3991
OG0021.982± 0.8350
OG0031.558± 0.6234
OG0041.683± 0.4367
OG005NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG0061.488± 0.5440
OG0071.955± 0.4608
OG008NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG010NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG011NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG0121.917± 1.229
2.049
± 0.6594
OG0041.805± 0.3995
OG005NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
Participants
OG004
3
ParticipantsOG0050
ParticipantsOG00614
ParticipantsOG0075
ParticipantsOG0081
ParticipantsOG0090
ParticipantsOG0101
ParticipantsOG0111
ParticipantsOG0126
Title
Measurements
OG0002.358± 1.545
OG0011.305± 0.2577
OG002NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG003NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG0042.102± 0.6167
OG0061.855± 0.5961
OG0072.324± 0.6424
OG008NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG010NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.
OG011NA± NAMean and standard deviation were not estimable for n\<3, as pre-specified in the SAP.