Safety, Tolerability, and Pharmacokinetic (PK) Study of D... | NCT03451162 | Trialant
NCT03451162
Sponsor
Genentech, Inc.
Status
Completed
Last Update Posted
Aug 5, 2024Actual
Enrollment
14Actual
Phase
Phase 1
Conditions
Breast Cancer
Interventions
DHES0815A
Countries
United States
South Korea
Protocol Section
Identification Module
NCT ID
NCT03451162
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GO39869
Secondary IDs
Not provided
Brief Title
Safety, Tolerability, and Pharmacokinetic (PK) Study of DHES0815A in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Breast Cancer
Official Title
A Phase I, Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Escalating Doses of DHES0815A in Patients With HER2-Positive Breast Cancer
Acronym
Not provided
Organization
Genentech, Inc.INDUSTRY
Status Module
Record Verification Date
Feb 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 17, 2018Actual
Primary Completion Date
Jul 16, 2021Actual
Completion Date
Jul 16, 2021Actual
First Submitted Date
Feb 16, 2018
First Submission Date that Met QC Criteria
Feb 23, 2018
First Posted Date
Mar 1, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Jun 23, 2022
Results First Submitted that Met QC Criteria
Feb 25, 2024
Results First Posted Date
Aug 5, 2024Actual
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
Feb 25, 2024
Last Update Posted Date
Aug 5, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Genentech, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
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 first-in-human, Phase 1, open-label, multicenter, dose-escalation study will evaluate the safety, tolerability, and PK of DHES0815A as a single agent in participants with advanced and/or metastatic HER2-positive breast cancer for whom established treatment has proven ineffective or intolerable or is unavailable. The study may include a dose-expansion cohort (based on an ongoing assessment of the totality of data obtained in this study) to further assess safety, tolerability, PK, and preliminary anti-tumor activity.
Detailed Description
Not provided
Conditions Module
Conditions
Breast Cancer
Keywords
Not provided
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
14Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Dose Escalation Cohort: DHES0815A
Experimental
Participants will receive DHES0815A in escalating doses in the dose-escalation cohort of the study. Participants will receive additional infusions of DHES0815A on Day 1 of subsequent cycles provided that they meet the protocol specified criteria for acceptable toxicity and ongoing clinical benefit.
Drug: DHES0815A
Dose Expansion Cohort: DHES0815A
Experimental
Participants will be treated at or below the Maximum Tolerated Dose (MTD) of DHES0815A (based on the review of the totality of the data) to obtain additional safety, tolerability, PK, and anti-tumor activity data.
Drug: DHES0815A
Interventions
Name
Type
Description
Arm Group Labels
Other Names
DHES0815A
Drug
DHES0815A will be administered via intravenous (IV) infusion on Day 1 of each 21-day cycle.
Dose Escalation Cohort: DHES0815A
Dose Expansion Cohort: DHES0815A
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) With Severity Determined as Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. SAE is any AE that is fatal, is life threatening, requires or prolongs inpatient hospitalization, results in persistent/significant disability/incapacity and is congenital anomaly/birth defect. Severity of AEs were graded per NCI CTCAE v4.0. Grade 1: Mild; asymptomatic/mild symptoms; clinical/diagnostic observations only; or intervention not indicated; Grade 2: Moderate; minimal, local/non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3: Severe/medically significant, but not immediately life-threatening: hospitalization/prolongation of hospitalization indicated; disabling/limiting self-care activities of daily living; Grade 4: Life-threatening consequences/urgent intervention indicated; Grade 5: Death related to AE.
From Day 1 to end of study (up to approximately 39 months)
Number of Participants With Dose-limiting Toxicity (DLT)
DLT=any one events occurring during DLT assessment window: ≥15% decrease from baseline in left ventricular ejection fraction (LVEF)/≥10% decrease to <50% LVEF; Grade ≥ 3 non-hematologic toxicity; Grade ≥4 neutropenia (absolute neutrophil count <500 cells/microliters [μL]) lasting <7 days; Grade ≥3 febrile neutropenia; Grade ≥4 anemia; Grade ≥4 thrombocytopenia; Grade 3 thrombocytopenia associated with clinically significant bleeding; Any increase in hepatic transaminase (ALT or AST) >3*baseline in combination with either an increase in direct bilirubin >2*upper limit of normal/clinical jaundice, in absence of cholestasis/other contributory factors. NCI CTCAE v4.0. was used to grade these events.Grade1: Mild; asymptomatic/mild symptoms; clinical/diagnostic observations only; Grade2: Moderate; minimal, local/non-invasive intervention indicated;Grade3: Severe/medically significant, but not immediately life-threatening;Grade4: Life-threatening consequences/urgent intervention indicated.
From Day 1 up to Day 21
Duration of Treatment
Secondary Outcomes
Measure
Description
Time Frame
Concentration of DHES0815A Total Antibody
DHES0815A total antibody is one of three key pharmacokinetic analytes of DHES0815A.
Pre-dose and 30 minutes (min) post-dose on Day 1 Cycles 1-4; 4 hour (h) post-dose on Day 1 Cycle1; post-dose on Days 2, 3, 11, 17 Cycle 1; post-dose on Days 8 and 15 Cycles 1-4; study discontinuation visit (up to approx. 39 months) (Cycle length=21 days)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Measurable disease by RECIST v1.1 with at least one measurable target lesion
Locally advanced or metastatic HER2-positive breast cancer that has relapsed or is refractory to established therapies
Adequate hematologic and end-organ function
For dose-expansion cohort only: no more than two prior systemic chemotherapy-containing regimens in the advanced/metastatic setting (excluding trastuzumab emtansine, which is considered a targeted cytotoxic agent)
Key Exclusion Criteria:
Treatment with chemotherapy, hormonal therapy (except hormone replacement therapy, oral contraceptives), immunotherapy, biologic therapy, radiation therapy (except palliative radiation to bony metastases), or herbal therapy as cancer therapy within 4 weeks prior to initiation of DHES0815A
History of exposure to the protocol specified doses of anthracyclines
Pregnancy, lactation, or breastfeeding
Major surgical procedure within 4 weeks prior to Day 1
Evidence of a significant uncontrolled concomitant disease of the nervous system, pulmonary, autoimmune, renal, hepatic, endocrine, or gastrointestinal disorders; or a serious non-healing wound or fracture
Known active bacterial, viral, fungal, mycobacterial, or other infection
Clinically significant history of liver disease, including active viral or other hepatitis, current alcohol abuse, or cirrhosis
Untreated or active central nervous system (CNS) metastases
Cardiopulmonary dysfunction, including inadequate left ventricular ejection function at baseline, less than 50% by either echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
QT interval corrected through use of Fridericia's formula (QTcF) > 470 milliseconds (ms)
Lewis GD, Li G, Guo J, Yu SF, Fields CT, Lee G, Zhang D, Dragovich PS, Pillow T, Wei B, Sadowsky J, Leipold D, Wilson T, Kamath A, Mamounas M, Lee MV, Saad O, Choeurng V, Ungewickell A, Monemi S, Crocker L, Kalinsky K, Modi S, Jung KH, Hamilton E, LoRusso P, Krop I, Schutten MM, Commerford R, Sliwkowski MX, Cho E. The HER2-directed antibody-drug conjugate DHES0815A in advanced and/or metastatic breast cancer: preclinical characterization and phase 1 trial results. Nat Commun. 2024 Jan 11;15(1):466. doi: 10.1038/s41467-023-44533-z.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
No participants were enrolled in the Dose Expansion Cohort.
Recruitment Details
Participants took part in this study at 5 investigative sites in Republic of Korea and United States from 17 April 2018 to 16 July 2021.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Dose Escalation Cohort: DHES0815A 0.6 mg/kg
Participants received DHES0815A 0.6 milligrams per kilograms (mg/kg) as an intravenous (IV) infusion, every three weeks (Q3W) on Day 1 of each 21-day cycle.
FG001
Dose Escalation Cohort: DHES0815A 1.2 mg/kg
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
Not provided
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_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
May 8, 2019
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
MeSH Terms
Non-Randomized
Intervention Model
Sequential 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
Treatment duration was calculated from the first dose of study drug to the last dose of study drug administration.
From Day 1 up to last dose of study drug (up to approximately 39 months)
Total Cumulative Dose
From Day 1 up to last dose of study drug (up to approximately 39 months)
Change From Baseline in LVEF as Assessed by Echocardiogram (ECHO) or Multiple-Gated Acquisition (MUGA) Scan
LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heartbeat and is a measure of cardiac output for the heart. Baseline LVEF value and the change from baseline to the worst value in LVEF measurement were reported. LVEF was measured by ECHO or MUGA scan.
Baseline, end of Cycle 1, Days 15-21 of Cycles 2, 4, and 6, and every four cycles thereafter up to the study discontinuation visit (up to approximately 39 months)
Concentration of Plasma Conjugated Pyrrolo [2,1-c] [1,4] Benzodiazepine Monoamide (PDB-MA)
Conjugated PDB-MA is one of three key pharmacokinetic analytes of DHES0815A.
Pre-dose and 30 minutes (min) post-dose on Day 1 Cycles 1-4; 4 hour (h) post-dose on Day 1 Cycle1; post-dose on Days 2, 3, 11, 17 Cycle 1; post-dose on Days 8 and 15 Cycles 1-4; study discontinuation visit (up to approx. 39 months) (Cycle length=21 days)
Concentration of Plasma Unconjugated PDB-MA
Plasma Unconjugated PDB-MA is one of three key pharmacokinetic analytes of DHES0815A.
Pre-dose and 30 minutes (min) post-dose on Day 1 Cycles 1-4; 4 hour (h) post-dose on Day 1 Cycle1; post-dose on Days 2, 3, 11, 17 Cycle 1; post-dose on Days 8 and 15 Cycles 1-4; study discontinuation visit (up to approx. 39 months) (Cycle length=21 days)
Number of Participants With Objective Response Assessed According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Objective response was defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR, defined as disappearance of all target lesions. PR, defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR.
From start of treatment until confirmation of CR or PR (up to approximately 39 months)
Duration of Response (DoR) Assessed According to RECIST v1.1
DOR was defined as the time from the first occurrence of a documented objective response to disease progression (PD) or death from any cause, whichever occurred first, as determined by the investigator according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).
From the initial CR or PR to the time of PD or death, whichever occurs first (up to approximately 39 months)
Number of Participants With Anti-Drug Antibody (ADA) to DHES0815A
Number of participants with treatment induced and treatment-enhanced ADA are reported here. Participants were considered to have treatment-induced ADA responses if they were ADA negative at baseline and developed an ADA response following DHES0815A administration. Participants were considered to have treatment-enhanced ADA if they were ADA positive at baseline and the titer of one or more postbaseline samples is at least 4-fold greater than baseline titer (i.e., ≥ 0.60 titer units) following study drug administration.
Pre-dose on Day 1 of Cycles 1-4 and 42 days after last infusion (up to approximately 39 months)
Boston
Massachusetts
02215
United States
Memorial Sloan Kettering Cancer Center
New York
New York
11101
United States
Sarah Cannon Research Institute
Nashville
Tennessee
37203
United States
Asan Medical Center
Seoul
05505
South Korea
Participants received DHES0815A 1.2 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
FG002
Dose Escalation Cohort: DHES0815A 2.4 mg/kg
Participants received DHES0815A 2.4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
FG003
Dose Escalation Cohort: DHES0815A 4 mg/kg
Participants received DHES0815A 4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle up to Cycle 3. Due to toxicities observed in participants after Cycle 3, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
FG004
Dose Escalation Cohort: DHES0815A 6 mg/kg
Participants received DHES0815A 6 mg/kg as IV infusion, Q3W on Day 1 of each 21-day cycle. Due to toxicities observed in participants after 3 cycles of DHES0815A 4 mg/kg, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0042 subjects
COMPLETED
FG0001 subjects
FG0011 subjects
FG0023 subjects
FG0033 subjects
FG0042 subjects
NOT COMPLETED
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Safety evaluable population included all enrolled participants who received at least one dose of study medication.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Dose Escalation Cohort: DHES0815A 0.6 mg/kg
Participants received DHES0815A 0.6 milligrams per kilograms (mg/kg) as an intravenous (IV) infusion, every three weeks (Q3W) on Day 1 of each 21-day cycle.
BG001
Dose Escalation Cohort: DHES0815A 1.2 mg/kg
Participants received DHES0815A 1.2 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
BG002
Dose Escalation Cohort: DHES0815A 2.4 mg/kg
Participants received DHES0815A 2.4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
BG003
Dose Escalation Cohort: DHES0815A 4 mg/kg
Participants received DHES0815A 4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle up to Cycle 3. Due to toxicities observed in participants after Cycle 3, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
BG004
Dose Escalation Cohort: DHES0815A 6 mg/kg
Participants received DHES0815A 6 mg/kg as IV infusion, Q3W on Day 1 of each 21-day cycle. Due to toxicities observed in participants after 3 cycles of DHES0815A 4 mg/kg, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0023
BG0033
BG0042
BG00514
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
BG00064.3± 6.1
BG00158.3± 4.5
BG00249.3± 8.3
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0013
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
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
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) With Severity Determined as Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. SAE is any AE that is fatal, is life threatening, requires or prolongs inpatient hospitalization, results in persistent/significant disability/incapacity and is congenital anomaly/birth defect. Severity of AEs were graded per NCI CTCAE v4.0. Grade 1: Mild; asymptomatic/mild symptoms; clinical/diagnostic observations only; or intervention not indicated; Grade 2: Moderate; minimal, local/non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3: Severe/medically significant, but not immediately life-threatening: hospitalization/prolongation of hospitalization indicated; disabling/limiting self-care activities of daily living; Grade 4: Life-threatening consequences/urgent intervention indicated; Grade 5: Death related to AE.
Safety evaluable population included all enrolled participants who received at least one dose of study medication.
Posted
Count of Participants
Participants
From Day 1 to end of study (up to approximately 39 months)
ID
Title
Description
OG000
Dose Escalation Cohort: DHES0815A 0.6 mg/kg
Participants received DHES0815A 0.6 milligrams per kilograms (mg/kg) as an intravenous (IV) infusion, every three weeks (Q3W) on Day 1 of each 21-day cycle.
OG001
Dose Escalation Cohort: DHES0815A 1.2 mg/kg
Participants received DHES0815A 1.2 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
OG002
Dose Escalation Cohort: DHES0815A 2.4 mg/kg
Participants received DHES0815A 2.4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
OG003
Dose Escalation Cohort: DHES0815A 4 mg/kg
Participants received DHES0815A 4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle up to Cycle 3. Due to toxicities observed in participants after Cycle 3, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
OG004
Dose Escalation Cohort: DHES0815A 6 mg/kg
Participants received DHES0815A 6 mg/kg as IV infusion, Q3W on Day 1 of each 21-day cycle. Due to toxicities observed in participants after 3 cycles of DHES0815A 4 mg/kg, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
AEs
Title
Measurements
OG0003
OG0013
OG0023
OG003
Primary
Number of Participants With Dose-limiting Toxicity (DLT)
DLT=any one events occurring during DLT assessment window: ≥15% decrease from baseline in left ventricular ejection fraction (LVEF)/≥10% decrease to <50% LVEF; Grade ≥ 3 non-hematologic toxicity; Grade ≥4 neutropenia (absolute neutrophil count <500 cells/microliters [μL]) lasting <7 days; Grade ≥3 febrile neutropenia; Grade ≥4 anemia; Grade ≥4 thrombocytopenia; Grade 3 thrombocytopenia associated with clinically significant bleeding; Any increase in hepatic transaminase (ALT or AST) >3*baseline in combination with either an increase in direct bilirubin >2*upper limit of normal/clinical jaundice, in absence of cholestasis/other contributory factors. NCI CTCAE v4.0. was used to grade these events.Grade1: Mild; asymptomatic/mild symptoms; clinical/diagnostic observations only; Grade2: Moderate; minimal, local/non-invasive intervention indicated;Grade3: Severe/medically significant, but not immediately life-threatening;Grade4: Life-threatening consequences/urgent intervention indicated.
Safety evaluable population included all enrolled participants who received at least one dose of study medication.
Posted
Count of Participants
Participants
From Day 1 up to Day 21
ID
Title
Description
OG000
Dose Escalation Cohort: DHES0815A 0.6 mg/kg
Participants received DHES0815A 0.6 milligrams per kilograms (mg/kg) as an intravenous (IV) infusion, every three weeks (Q3W) on Day 1 of each 21-day cycle.
OG001
Dose Escalation Cohort: DHES0815A 1.2 mg/kg
Primary
Duration of Treatment
Treatment duration was calculated from the first dose of study drug to the last dose of study drug administration.
Safety evaluable population included all enrolled participants who received at least one dose of study medication.
Posted
Median
Full Range
days
From Day 1 up to last dose of study drug (up to approximately 39 months)
ID
Title
Description
OG000
Dose Escalation Cohort: DHES0815A 0.6 mg/kg
Participants received DHES0815A 0.6 milligrams per kilograms (mg/kg) as an intravenous (IV) infusion, every three weeks (Q3W) on Day 1 of each 21-day cycle.
OG001
Dose Escalation Cohort: DHES0815A 1.2 mg/kg
Participants received DHES0815A 1.2 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
OG002
Dose Escalation Cohort: DHES0815A 2.4 mg/kg
Participants received DHES0815A 2.4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
OG003
Dose Escalation Cohort: DHES0815A 4 mg/kg
Participants received DHES0815A 4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle up to Cycle 3. Due to toxicities observed in participants after Cycle 3, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
Primary
Total Cumulative Dose
Safety evaluable population included all enrolled participants who received at least one dose of study medication.
Posted
Mean
Standard Deviation
milligrams (mg)
From Day 1 up to last dose of study drug (up to approximately 39 months)
ID
Title
Description
OG000
Dose Escalation Cohort: DHES0815A 0.6 mg/kg
Participants received DHES0815A 0.6 milligrams per kilograms (mg/kg) as an intravenous (IV) infusion, every three weeks (Q3W) on Day 1 of each 21-day cycle.
OG001
Dose Escalation Cohort: DHES0815A 1.2 mg/kg
Participants received DHES0815A 1.2 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
OG002
Dose Escalation Cohort: DHES0815A 2.4 mg/kg
Participants received DHES0815A 2.4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
OG003
Dose Escalation Cohort: DHES0815A 4 mg/kg
Participants received DHES0815A 4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle up to Cycle 3. Due to toxicities observed in participants after Cycle 3, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
Primary
Change From Baseline in LVEF as Assessed by Echocardiogram (ECHO) or Multiple-Gated Acquisition (MUGA) Scan
LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heartbeat and is a measure of cardiac output for the heart. Baseline LVEF value and the change from baseline to the worst value in LVEF measurement were reported. LVEF was measured by ECHO or MUGA scan.
Safety evaluable population included all enrolled participants who received at least one dose of study medication.
Posted
Mean
Standard Deviation
percentage points of LVEF
Baseline, end of Cycle 1, Days 15-21 of Cycles 2, 4, and 6, and every four cycles thereafter up to the study discontinuation visit (up to approximately 39 months)
ID
Title
Description
OG000
Dose Escalation Cohort: DHES0815A 0.6 mg/kg
Participants received DHES0815A 0.6 milligrams per kilograms (mg/kg) as an intravenous (IV) infusion, every three weeks (Q3W) on Day 1 of each 21-day cycle.
OG001
Dose Escalation Cohort: DHES0815A 1.2 mg/kg
Participants received DHES0815A 1.2 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
OG002
Dose Escalation Cohort: DHES0815A 2.4 mg/kg
Participants received DHES0815A 2.4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
Secondary
Concentration of DHES0815A Total Antibody
DHES0815A total antibody is one of three key pharmacokinetic analytes of DHES0815A.
Pharmacokinetics (PK) evaluable population included all enrolled participants who received at least one dose of study medication. Number analyzed is the number of participants with evaluable data at specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per milliliters (ng/mL)
Pre-dose and 30 minutes (min) post-dose on Day 1 Cycles 1-4; 4 hour (h) post-dose on Day 1 Cycle1; post-dose on Days 2, 3, 11, 17 Cycle 1; post-dose on Days 8 and 15 Cycles 1-4; study discontinuation visit (up to approx. 39 months) (Cycle length=21 days)
ID
Title
Description
OG000
Dose Escalation Cohort: DHES0815A 0.6 mg/kg
Participants received DHES0815A 0.6 milligrams per kilograms (mg/kg) as an intravenous (IV) infusion, every three weeks (Q3W) on Day 1 of each 21-day cycle.
OG001
Dose Escalation Cohort: DHES0815A 1.2 mg/kg
Participants received DHES0815A 1.2 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
OG002
Dose Escalation Cohort: DHES0815A 2.4 mg/kg
Participants received DHES0815A 2.4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
Secondary
Concentration of Plasma Conjugated Pyrrolo [2,1-c] [1,4] Benzodiazepine Monoamide (PDB-MA)
Conjugated PDB-MA is one of three key pharmacokinetic analytes of DHES0815A.
PK evaluable population included all enrolled participants who received at least one dose of study medication. Number analyzed is the number of participants with evaluable data at specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose and 30 minutes (min) post-dose on Day 1 Cycles 1-4; 4 hour (h) post-dose on Day 1 Cycle1; post-dose on Days 2, 3, 11, 17 Cycle 1; post-dose on Days 8 and 15 Cycles 1-4; study discontinuation visit (up to approx. 39 months) (Cycle length=21 days)
ID
Title
Description
OG000
Dose Escalation Cohort: DHES0815A 0.6 mg/kg
Participants received DHES0815A 0.6 milligrams per kilograms (mg/kg) as an intravenous (IV) infusion, every three weeks (Q3W) on Day 1 of each 21-day cycle.
OG001
Dose Escalation Cohort: DHES0815A 1.2 mg/kg
Participants received DHES0815A 1.2 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
OG002
Dose Escalation Cohort: DHES0815A 2.4 mg/kg
Participants received DHES0815A 2.4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
Secondary
Concentration of Plasma Unconjugated PDB-MA
Plasma Unconjugated PDB-MA is one of three key pharmacokinetic analytes of DHES0815A.
PK evaluable population included all enrolled participants who received at least one dose of study medication. Number analyzed is the number of participants with evaluable data at specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose and 30 minutes (min) post-dose on Day 1 Cycles 1-4; 4 hour (h) post-dose on Day 1 Cycle1; post-dose on Days 2, 3, 11, 17 Cycle 1; post-dose on Days 8 and 15 Cycles 1-4; study discontinuation visit (up to approx. 39 months) (Cycle length=21 days)
ID
Title
Description
OG000
Dose Escalation Cohort: DHES0815A 0.6 mg/kg
Participants received DHES0815A 0.6 milligrams per kilograms (mg/kg) as an intravenous (IV) infusion, every three weeks (Q3W) on Day 1 of each 21-day cycle.
OG001
Dose Escalation Cohort: DHES0815A 1.2 mg/kg
Participants received DHES0815A 1.2 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
OG002
Dose Escalation Cohort: DHES0815A 2.4 mg/kg
Participants received DHES0815A 2.4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
Secondary
Number of Participants With Objective Response Assessed According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Objective response was defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR, defined as disappearance of all target lesions. PR, defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR.
Safety evaluable population included all enrolled participants who received at least one dose of study medication.
Posted
Count of Participants
Participants
From start of treatment until confirmation of CR or PR (up to approximately 39 months)
ID
Title
Description
OG000
Dose Escalation Cohort: DHES0815A 0.6 mg/kg
Participants received DHES0815A 0.6 milligrams per kilograms (mg/kg) as an intravenous (IV) infusion, every three weeks (Q3W) on Day 1 of each 21-day cycle.
OG001
Dose Escalation Cohort: DHES0815A 1.2 mg/kg
Participants received DHES0815A 1.2 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
OG002
Dose Escalation Cohort: DHES0815A 2.4 mg/kg
Secondary
Duration of Response (DoR) Assessed According to RECIST v1.1
DOR was defined as the time from the first occurrence of a documented objective response to disease progression (PD) or death from any cause, whichever occurred first, as determined by the investigator according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).
Safety evaluable population included all enrolled participants who received at least one dose of study medication. DoR was only evaluated in participants who achieved an objective response (CR or PR).
Posted
Median
95% Confidence Interval
months
From the initial CR or PR to the time of PD or death, whichever occurs first (up to approximately 39 months)
ID
Title
Description
OG000
Dose Escalation Cohort: DHES0815A 0.6 mg/kg
Participants received DHES0815A 0.6 milligrams per kilograms (mg/kg) as an intravenous (IV) infusion, every three weeks (Q3W) on Day 1 of each 21-day cycle.
OG001
Dose Escalation Cohort: DHES0815A 1.2 mg/kg
Participants received DHES0815A 1.2 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
OG002
Secondary
Number of Participants With Anti-Drug Antibody (ADA) to DHES0815A
Number of participants with treatment induced and treatment-enhanced ADA are reported here. Participants were considered to have treatment-induced ADA responses if they were ADA negative at baseline and developed an ADA response following DHES0815A administration. Participants were considered to have treatment-enhanced ADA if they were ADA positive at baseline and the titer of one or more postbaseline samples is at least 4-fold greater than baseline titer (i.e., ≥ 0.60 titer units) following study drug administration.
Safety evaluable population included all enrolled participants who received at least one dose of study medication.
Posted
Count of Participants
Participants
Pre-dose on Day 1 of Cycles 1-4 and 42 days after last infusion (up to approximately 39 months)
ID
Title
Description
OG000
Dose Escalation Cohort: DHES0815A 0.6 mg/kg
Participants received DHES0815A 0.6 milligrams per kilograms (mg/kg) as an intravenous (IV) infusion, every three weeks (Q3W) on Day 1 of each 21-day cycle.
OG001
Dose Escalation Cohort: DHES0815A 1.2 mg/kg
Participants received DHES0815A 1.2 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
OG002
Dose Escalation Cohort: DHES0815A 2.4 mg/kg
Time Frame
From Day 1 to end of study (up to approximately 39 months)
Description
Safety evaluable population included all enrolled participants who received at least one dose of study medication.
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 Cohort: DHES0815A 0.6 mg/kg
Participants received DHES0815A 0.6 milligrams per kilograms (mg/kg) as an intravenous (IV) infusion, every three weeks (Q3W) on Day 1 of each 21-day cycle.
0
3
1
3
3
3
EG001
Dose Escalation Cohort: DHES0815A 1.2 mg/kg
Participants received DHES0815A 1.2 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
0
3
1
3
3
3
EG002
Dose Escalation Cohort: DHES0815A 2.4 mg/kg
Participants received DHES0815A 2.4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
0
3
1
3
3
3
EG003
Dose Escalation Cohort: DHES0815A 4 mg/kg
Participants received DHES0815A 4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle up to Cycle 3. Due to toxicities observed in participants after Cycle 3, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
0
3
0
3
3
3
EG004
Dose Escalation Cohort: DHES0815A 6 mg/kg
Participants received DHES0815A 6 mg/kg as IV infusion, Q3W on Day 1 of each 21-day cycle. Due to toxicities observed in participants after 3 cycles of DHES0815A 4 mg/kg, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
0
2
1
2
2
2
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Bradycardia
Cardiac disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected2 at risk
Appendicitis
Infections and infestations
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 24.0
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 24.0
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Thrombosis
Vascular disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 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
Anaemia
Blood and lymphatic system disorders
MedDRA version 24.0
Systematic Assessment
EG0002 events2 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected2 at risk
Atrial fibrillation
Cardiac disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blepharitis
Eye disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cataract
Eye disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dry eye
Eye disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Eye pain
Eye disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Photophobia
Eye disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Punctate keratitis
Eye disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Retinal tear
Eye disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected3 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0022 events2 affected3 at risk
EG003
Oedema
General disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pain
General disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Peripheral swelling
General disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0013 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tremor
Nervous system disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 24.0
Systematic Assessment
EG0002 events2 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Telangiectasia
Skin and subcutaneous tissue disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA version 24.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA version 24.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Participants received DHES0815A 1.2 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
OG002
Dose Escalation Cohort: DHES0815A 2.4 mg/kg
Participants received DHES0815A 2.4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
OG003
Dose Escalation Cohort: DHES0815A 4 mg/kg
Participants received DHES0815A 4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle up to Cycle 3. Due to toxicities observed in participants after Cycle 3, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
OG004
Dose Escalation Cohort: DHES0815A 6 mg/kg
Participants received DHES0815A 6 mg/kg as IV infusion, Q3W on Day 1 of each 21-day cycle. Due to toxicities observed in participants after 3 cycles of DHES0815A 4 mg/kg, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0042
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG004
Dose Escalation Cohort: DHES0815A 6 mg/kg
Participants received DHES0815A 6 mg/kg as IV infusion, Q3W on Day 1 of each 21-day cycle. Due to toxicities observed in participants after 3 cycles of DHES0815A 4 mg/kg, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0042
Title
Denominators
Categories
Title
Measurements
OG00064.0(62 to 533)
OG001208.0(85 to 960)
OG00243.0(43 to 66)
OG00364.0(64 to 127)
OG00443.0(43 to 43)
OG004
Dose Escalation Cohort: DHES0815A 6 mg/kg
Participants received DHES0815A 6 mg/kg as IV infusion, Q3W on Day 1 of each 21-day cycle. Due to toxicities observed in participants after 3 cycles of DHES0815A 4 mg/kg, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0042
Title
Denominators
Categories
Title
Measurements
OG000882.33± 1355.91
OG0012143.00± 2523.37
OG002342.27± 157.78
OG0031340.20± 586.56
OG004548.80± 138.59
OG003
Dose Escalation Cohort: DHES0815A 4 mg/kg
Participants received DHES0815A 4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle up to Cycle 3. Due to toxicities observed in participants after Cycle 3, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
OG004
Dose Escalation Cohort: DHES0815A 6 mg/kg
Participants received DHES0815A 6 mg/kg as IV infusion, Q3W on Day 1 of each 21-day cycle. Due to toxicities observed in participants after 3 cycles of DHES0815A 4 mg/kg, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0042
Title
Denominators
Categories
Baseline
Title
Measurements
OG00059.00± 3.61
OG00163.33± 4.04
OG00264.00± 9.54
OG00359.67± 0.58
OG00462.50± 3.54
Change From Baseline to Worst Value
Title
Measurements
OG0000.33± 4.04
OG001-1.67± 1.15
OG002-4.67± 7.77
OG003
OG003
Dose Escalation Cohort: DHES0815A 4 mg/kg
Participants received DHES0815A 4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle up to Cycle 3. Due to toxicities observed in participants after Cycle 3, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
OG004
Dose Escalation Cohort: DHES0815A 6 mg/kg
Participants received DHES0815A 6 mg/kg as IV infusion, Q3W on Day 1 of each 21-day cycle. Due to toxicities observed in participants after 3 cycles of DHES0815A 4 mg/kg, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0042
Title
Denominators
Categories
Cycle 1 Day1: Predose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0042
Title
Measurements
OG000NA± NAThe data was not evaluable as the samples were below limit of quantification (BLQ).
OG001NA± NAThe data was not evaluable as the samples were BLQ.
OG002NA± NAThe data was not evaluable as the samples were BLQ.
OG003
Cycle 1 Day 1: 30 min Postdose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 1 Day 1: 4 h Postdose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 1 Day 2
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 1 Day 3
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0032
Cycle 1 Day 8
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0033
Cycle 1 Day 11
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0033
Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0032
Cycle 1 Day 17
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 2 Day 1: Predose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 2 Day 1: 30 min Postdose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 2 Day 8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Cycle 2 Day 15
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Cycle 3 Day 1: Predose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0033
Cycle 3 Day 1: 30 min Postdose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0033
Cycle 3 Day 8
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0033
Cycle 3 Day 15
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0033
Cycle 4 Day 1: Predose
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0031
Cycle 4 Day 1: 30 min Postdose
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0031
Cycle 4 Day 8
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0031
Cycle 4 Day 15
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0031
Study Drug Discontinuation Visit
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0032
OG003
Dose Escalation Cohort: DHES0815A 4 mg/kg
Participants received DHES0815A 4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle up to Cycle 3. Due to toxicities observed in participants after Cycle 3, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
OG004
Dose Escalation Cohort: DHES0815A 6 mg/kg
Participants received DHES0815A 6 mg/kg as IV infusion, Q3W on Day 1 of each 21-day cycle. Due to toxicities observed in participants after 3 cycles of DHES0815A 4 mg/kg, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0042
Title
Denominators
Categories
Cycle 1 Day1: Predose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0042
Title
Measurements
OG000NA± NAThe data was not evaluable as the samples were BLQ.
OG001NA± NAThe data was not evaluable as the samples were BLQ.
OG002NA± NAThe data was not evaluable as the samples were BLQ.
OG003
Cycle 1 Day 1: 30 min Postdose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 1 Day 1: 4 h Postdose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 1 Day 2
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 1 Day 3
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0032
Cycle 1 Day 8
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0033
Cycle 1 Day 11
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0033
Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0032
Cycle 1 Day 17
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 2 Day 1: Predose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 2 Day 1: 30 min Postdose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 2 Day 8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 2 Day 15
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 3 Day 1: Predose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0033
Cycle 3 Day 1: 30 min Postdose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0033
Cycle 3 Day 8
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0033
Cycle 3 Day 15
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0033
Cycle 4 Day 1: Predose
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0031
Cycle 4 Day 1: 30 min Postdose
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0031
Cycle 4 Day 8
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0031
Cycle 4 Day 15
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Study Drug Discontinuation Visit
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0030
OG003
Dose Escalation Cohort: DHES0815A 4 mg/kg
Participants received DHES0815A 4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle up to Cycle 3. Due to toxicities observed in participants after Cycle 3, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
OG004
Dose Escalation Cohort: DHES0815A 6 mg/kg
Participants received DHES0815A 6 mg/kg as IV infusion, Q3W on Day 1 of each 21-day cycle. Due to toxicities observed in participants after 3 cycles of DHES0815A 4 mg/kg, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0042
Title
Denominators
Categories
Cycle 1 Day1: Predose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0042
Title
Measurements
OG000NA± NAThe data was not evaluable as the samples were BLQ.
OG001NA± NAThe data was not evaluable as the samples were BLQ.
OG002NA± NAThe data was not evaluable as the samples were BLQ.
OG003
Cycle 1 Day 1: 30 min Postdose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 1 Day 1: 4 h Postdose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 1 Day 2
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 1 Day 3
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0032
Cycle 1 Day 8
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0033
Cycle 1 Day 11
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0033
Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0032
Cycle 1 Day 17
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 2 Day 1: Predose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 2 Day 1: 30 min Postdose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 2 Day 8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 2 Day 15
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 3 Day 1: Predose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0033
Cycle 3 Day 1: 30 min Postdose
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0033
Cycle 3 Day 8
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0033
Cycle 3 Day 15
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0033
Cycle 4 Day 1: Predose
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0031
Cycle 4 Day 1: 30 min Postdose
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0031
Cycle 4 Day 8
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0031
Cycle 4 Day 15
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0031
Study Drug Discontinuation Visit
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0032
Participants received DHES0815A 2.4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
OG003
Dose Escalation Cohort: DHES0815A 4 mg/kg
Participants received DHES0815A 4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle up to Cycle 3. Due to toxicities observed in participants after Cycle 3, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
OG004
Dose Escalation Cohort: DHES0815A 6 mg/kg
Participants received DHES0815A 6 mg/kg as IV infusion, Q3W on Day 1 of each 21-day cycle. Due to toxicities observed in participants after 3 cycles of DHES0815A 4 mg/kg, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0042
Title
Denominators
Categories
Complete Response (CR)
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
Partial Response (PR)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Dose Escalation Cohort: DHES0815A 2.4 mg/kg
Participants received DHES0815A 2.4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
OG003
Dose Escalation Cohort: DHES0815A 4 mg/kg
Participants received DHES0815A 4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle up to Cycle 3. Due to toxicities observed in participants after Cycle 3, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
OG004
Dose Escalation Cohort: DHES0815A 6 mg/kg
Participants received DHES0815A 6 mg/kg as IV infusion, Q3W on Day 1 of each 21-day cycle. Due to toxicities observed in participants after 3 cycles of DHES0815A 4 mg/kg, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0000
OG0011
OG0020
OG0030
OG0040
Title
Denominators
Categories
Title
Measurements
OG001NA(NA to NA)Since only one participant showed response, median and 95% confidence interval (CI) were not evaluable.
Participants received DHES0815A 2.4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle.
OG003
Dose Escalation Cohort: DHES0815A 4 mg/kg
Participants received DHES0815A 4 mg/kg as an IV infusion, Q3W on Day 1 of each 21-day cycle up to Cycle 3. Due to toxicities observed in participants after Cycle 3, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
OG004
Dose Escalation Cohort: DHES0815A 6 mg/kg
Participants received DHES0815A 6 mg/kg as IV infusion, Q3W on Day 1 of each 21-day cycle. Due to toxicities observed in participants after 3 cycles of DHES0815A 4 mg/kg, dosing was capped at 2.4 mg/kg and the participants received DHES0815A at a dose of 2.4 mg/kg as an IV infusion, Q3W from Cycle 4, on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0042
Title
Denominators
Categories
Baseline: ADA Positive
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0041
Post-baseline: Treatment-induced ADA Positive
Title
Measurements
OG0000
OG0011
OG0021
OG003
Post-baseline: Treatment-enhanced ADA Positive
Title
Measurements
OG0000
OG0010
OG0020
OG003
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected2 at risk
1 events
1 affected
3 at risk
EG0041 events1 affected2 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected2 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected2 at risk
2 events
2 affected
3 at risk
EG0041 events1 affected2 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected2 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0043 events2 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
1 events
1 affected
3 at risk
EG0041 events1 affected2 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
1 events
1 affected
3 at risk
EG0042 events2 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected2 at risk
1 events
1 affected
3 at risk
EG0041 events1 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected2 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected2 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected2 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected2 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected2 at risk
2 events
1 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected2 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected2 at risk
2 events
2 affected
3 at risk
EG0041 events1 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected2 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected2 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected2 at risk
2 events
1 affected
3 at risk
EG0041 events1 affected2 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected2 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected2 at risk
4 events
3 affected
3 at risk
EG0042 events1 affected2 at risk
4 events
2 affected
3 at risk
EG0042 events1 affected2 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected2 at risk
2 events
2 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected2 at risk
2 events
1 affected
3 at risk
EG0040 events0 affected2 at risk
-1.33
± 1.53
OG004-5.00± 0.00
NA
± NA
The data was not evaluable as the samples were BLQ.
OG004NA± NAThe data was not evaluable as the samples were BLQ.
ParticipantsOG0042
Title
Measurements
OG00013100± 27.2
OG00148700± 29.0
OG00249200± 27.3
OG00388600± 11.4
OG004119000± 0.0
ParticipantsOG0042
Title
Measurements
OG00012200± 30.7
OG00130500± 13.0
OG00246900± 19.2
OG00385900± 13.6
OG004106000± 0.0
Participants
OG004
2
Title
Measurements
OG0008460± 34.9
OG00127000± 18.7
OG00235500± 46.5
OG00369100± 13.2
OG00496800± 11.6
Participants
OG004
2
Title
Measurements
OG0006330± 37.1
OG00122000± 14.5
OG00226600± 52.3
OG00359700± 9.7
OG00481100± 15.8
Participants
OG004
2
Title
Measurements
OG000625± 411.4
OG0018120± 42.1
OG00210700± 76.8
OG00336000± 8.8
OG00448000± 6.3
Participants
OG004
2
Title
Measurements
OG000225± NAValues were less than reportable (LTR) for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.
OG0014870± 34.2
OG0026840± 90.1
OG00326000± 5.1
OG00442100± 26.7
Participants
OG004
2
Title
Measurements
OG00064.8± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0012160± 69.1
OG0022100± 135.7
OG00322800± 0.3
OG00431300± 27.7
Participants
OG004
2
Title
Measurements
OG00050.0± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0011030± 190.3
OG002981± 148.8
OG00318800± 28.3
OG00429700± 36.7
ParticipantsOG0042
Title
Measurements
OG00050.0± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG00166.0± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG00250.0± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG00310500± 46.2
OG00419900± 27.3
ParticipantsOG0042
Title
Measurements
OG00011900± 29.6
OG00133000± 28.8
OG00230800± 101.0
OG00397700± 15.8
OG00485400± 62.2
Participants
OG004
1
Title
Measurements
OG000933± 165.1
OG0019500± 11.1
OG00210800± 46.2
OG00344300± 8.5
OG00480000± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
Participants
OG004
2
Title
Measurements
OG00050.0± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0012230± 37.2
OG0021330± 78.7
OG00327600± 12.9
OG00431100± 123.0
ParticipantsOG0040
Title
Measurements
OG00050.0± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG00150.00± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG00250.0± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG00318900± 38.9
ParticipantsOG0040
Title
Measurements
OG00013600± 21.6
OG00139300± 52.9
OG00256900± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG003119000± 14.1
Participants
OG004
0
Title
Measurements
OG000765± 921.0
OG0019740± 19.7
OG0028720± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG00351900± 20.0
Participants
OG004
0
Title
Measurements
OG00050.0± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0012530± 66.3
OG00330200± 24.7
ParticipantsOG0040
Title
Measurements
OG00050.0± NAValues were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.
OG00165.8± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG00313800± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
ParticipantsOG0040
Title
Measurements
OG0008750± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG00132800± 16.8
OG00383900± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
Participants
OG004
0
Title
Measurements
OG0002130± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG00111100± 23.5
OG00324200± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
Participants
OG004
0
Title
Measurements
OG00050.0± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0013000± 72.6
OG00313500± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
ParticipantsOG0041
Title
Measurements
OG000231± NAValues were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.
OG001483± NAValues were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.
OG00275.5± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG00350.0± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG00427800± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
NA
± NA
The data was not evaluable as the samples were BLQ.
OG004NA± NAThe data was not evaluable as the samples were BLQ.
ParticipantsOG0042
Title
Measurements
OG00090.5± 23.4
OG001242± 11.4
OG002381± 28.0
OG003702± 3.8
OG004864± 4.4
ParticipantsOG0042
Title
Measurements
OG00084.4± 28.9
OG001234± 9.4
OG002338± 31.0
OG003666± 6.7
OG004837± 4.6
Participants
OG004
2
Title
Measurements
OG00055.6± 32.8
OG001186± 7.6
OG002234± 44.6
OG003508± 8.0
OG004693± 5.4
Participants
OG004
2
Title
Measurements
OG00038.2± 32.5
OG001147± 8.1
OG002183± 48.4
OG003440± 1.4
OG004577± 12.9
Participants
OG004
2
Title
Measurements
OG0003.52± 394.8
OG00153.8± 39.5
OG00258.2± 69.4
OG003225± 5.6
OG004328± 5.2
Participants
OG004
2
Title
Measurements
OG0002.04± NAValues were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.
OG00129.9± 33.7
OG00233.0± 71.7
OG003157± 6.4
OG004259± 26.2
Participants
OG004
2
Title
Measurements
OG0000.947± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG00111.6± 74.0
OG00210.5± 122.9
OG003118± 6.6
OG004174± 28.4
Participants
OG004
2
Title
Measurements
OG0000.750± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0014.45± 313.1
OG0024.40± 120.8
OG00382.9± 29.5
OG004160± 34.3
ParticipantsOG0042
Title
Measurements
OG0000.750± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0010.750± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0020.750± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG00344.9± 59.5
OG00490.6± 32.1
ParticipantsOG0042
Title
Measurements
OG00092.8± 14.7
OG001247± 19.4
OG002232± 92.5
OG003760± 10.4
OG004636± 53.8
Participants
OG004
1
Title
Measurements
OG0005.01± 182.3
OG00159.5± 14.7
OG00230.9± 183.6
OG003283± 11.5
OG004451± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
Participants
OG004
1
Title
Measurements
OG0000.750± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG00111.5± 35.6
OG0023.25± 224.3
OG003135± 16.3
OG004324± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
ParticipantsOG0040
Title
Measurements
OG0000.750± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0010.750± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0020.750± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG00376.3± 47.0
ParticipantsOG0040
Title
Measurements
OG000100± 12.1
OG001236± 17.5
OG002381± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG003803± 7.7
Participants
OG004
0
Title
Measurements
OG0003.63± NAValues were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.
OG00157.9± 16.5
OG00261.6± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG003294± 20.7
Participants
OG004
0
Title
Measurements
OG0000.750± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG00112.1± 53.9
OG003143± 30.8
ParticipantsOG0040
Title
Measurements
OG0000.750± NAValues were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.
OG0010.750± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG00358.6± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
ParticipantsOG0040
Title
Measurements
OG000112± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG001244± 17.0
OG003647± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
Participants
OG004
0
Title
Measurements
OG00155.8± 10.6
OG003139± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
Participants
OG004
0
Title
Measurements
OG0000.750± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG00113.8± 70.4
ParticipantsOG0040
Title
Measurements
OG0000.750± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0013.93± NAValues were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.
OG0021.38± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
NA
± NA
The data was not evaluable as the samples were BLQ.
OG004NA± NAThe data was not evaluable as the samples were BLQ.
ParticipantsOG0042
Title
Measurements
OG0000.107± 14.4
OG0010.362± 40.9
OG0020.497± 47.1
OG0030.772± 9.1
OG0041.05± 5.4
ParticipantsOG0042
Title
Measurements
OG0000.0770± 20.2
OG0010.276± 16.9
OG0020.328± 26.9
OG0030.546± 21.4
OG0040.985± 44.5
Participants
OG004
2
Title
Measurements
OG0000.0634± 27.8
OG0010.175± 2.9
OG0020.223± 72.6
OG0030.449± 43.9
OG0040.577± 18.5
Participants
OG004
2
Title
Measurements
OG0000.0568± 31.8
OG0010.130± 21.8
OG0020.179± 40.2
OG0030.252± 24.7
OG0040.332± 14.5
Participants
OG004
2
Title
Measurements
OG0000.0300± 6.1
OG0010.0800± 15.0
OG0020.0927± 25.0
OG0030.185± 32.4
OG0040.163± 37.7
Participants
OG004
2
Title
Measurements
OG0000.0172± NAValues were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.
OG0010.0605± 16.8
OG0020.0806± 15.2
OG0030.146± 54.3
OG0040.170± 43.2
Participants
OG004
2
Title
Measurements
OG0000.0120± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0010.0405± 19.7
OG0020.0490± 48.5
OG0030.110± 47.6
OG0040.103± 4.9
Participants
OG004
2
Title
Measurements
OG0000.0120± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0010.0337± 16.2
OG0020.0389± 54.4
OG0030.0896± 40.4
OG0040.101± 37.4
ParticipantsOG0042
Title
Measurements
OG0000.0120± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0010.0120± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0020.0178± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0030.0836± 69.5
OG0040.0991± 60.4
ParticipantsOG0042
Title
Measurements
OG0000.0969± 16.4
OG0010.324± 29.7
OG0020.321± 73.3
OG0030.953± 17.6
OG0040.693± 76.5
Participants
OG004
1
Title
Measurements
OG0000.0306± 14.3
OG0010.0846± 19.3
OG0020.0662± 68.0
OG0030.214± 51.4
OG0040.196± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
Participants
OG004
2
Title
Measurements
OG0000.0120± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0010.0435± 8.1
OG0020.0266± 96.3
OG0030.164± 30.7
OG0040.149± 45.0
ParticipantsOG0040
Title
Measurements
OG0000.0120± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0010.0120± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0020.0120± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0030.144± 49.1
ParticipantsOG0040
Title
Measurements
OG0000.132± 20.5
OG0010.327± 33.4
OG0020.716± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0031.09± 10.3
Participants
OG004
0
Title
Measurements
OG0000.0314± 0.7
OG0010.0785± 16.4
OG0020.102± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0030.236± 41.1
Participants
OG004
0
Title
Measurements
OG0000.0120± NASince majority of the values were LTR and data was evaluable only for 1 participant, geometric co-efficient of variation was not evaluable.
OG0010.0510± 14.4
OG0030.181± 40.1
ParticipantsOG0040
Title
Measurements
OG0000.0120± NAValues were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.
OG0010.0120± 23.9
OG0030.0938± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
ParticipantsOG0040
Title
Measurements
OG0000.0570± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0010.338± 23.9
OG0030.633± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
Participants
OG004
0
Title
Measurements
OG0000.0316± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0010.108± 19.1
OG0030.149± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
Participants
OG004
0
Title
Measurements
OG0000.0120± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
OG0010.0574± 17.3
OG0030.0906± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.
ParticipantsOG0041
Title
Measurements
OG0000.0226± NAValues were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.
OG0010.0452± 56.1
OG0020.0249± 71.8
OG0030.0120± NAValues were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not evaluable.
OG0040.0374± NASince only 1 participant was analyzed, the geometric coefficient of variation was not evaluable.