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The study was terminated due to a business decision.
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This study will assess the safety, efficacy, and pharmacokinetics of DS-6157a in participants with advanced gastrointestinal stromal tumors (GIST).
This study is a two-part, multicenter, open-label, multiple-dose, first-in-human study of the antibody-drug conjugate (ADC) DS-6157a given as a single agent to participants with gastrointestinal stromal tumor (GIST).
This study will include 2 parts:
Dose Escalation: Participants with histopathologically documented advanced GIST not amenable to curative therapy may be included in which the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of DS-6157a monotherapy will be determined.
Dose Expansion: Once the RDE(s) is established for DS-6157a (Part 1), enrollment in Dose Expansion (Part 2) will commence in 2 cohorts. Participants with GIST who have progressed on or are intolerant to imatinib (IM) and at least one post-IM treatment will be enrolled in Cohort 1, and participants with GIST who progressed on IM and had not received a post-IM treatment (2nd line) will be enrolled in Cohort 2.
The study was terminated after Dose Escalation and the study never proceeded to the Dose Expansion part.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation: DS-6157a | Experimental | Participants with advanced gastrointestinal stromal tumor (GIST) who will receive an intravenous infusion of DS-6157a (escalating doses starting at 1.6 mg/kg). |
|
| Dose Expansion: Cohort 1 (3rd line or later) treated at RDE | Experimental | Participants with advanced gastrointestinal stromal tumor (GIST) who have progressed on or are intolerant to imatinib (IM) and at least one post-IM treatment will receive DS-6157a at the recommended dose for expansion (RDE) based on the Dose Escalation phase. |
|
| Dose Expansion: Cohort 2 (2nd line) treated at RDE | Experimental | Participants with advanced gastrointestinal stromal tumor (GIST) who have progressed on imatinib (IM) and had not received a post-IM treatment (2nd line) will receive DS-6157a at the recommended dose for expansion (RDE) based on the Dose Escalation phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS-6157a | Drug | Administered as a single agent intravenously (IV) every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-limiting Toxicities (DLT) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | For hematologic toxicities, a DLT is defined as: Grade (Gr) 4 neutrophil count decreased lasting >7 days, Gr ≥3 febrile neutropenia, Gr ≥3 anemia requiring transfusion, Gr 4 anemia, Gr 4 platelet count decreased, Gr ≥3 platelet count decreased lasting >7 days or associated with clinically significant hemorrhage and/or requiring transfusion, and Gr 4 lymphocyte count decreased lasting ≥14 days. For non-hematologic, non-hepatic major organ toxicities, a DLT is all TEAEs of Gr ≥3 except: Gr 3 fatigue lasting <7 days, Gr 3 nausea, vomiting, diarrhea, or anorexia that has resolved to Gr ≤2 within 3 days with maximal medical management, Gr 3 isolated lab findings not associated with signs or symptoms including alkaline phosphatase increased, hyperuricemia, serum amylase increased, and lipase increased, and Gr 3 hyponatremia lasting <72 hours developed from Gr 1 at baseline. Symptomatic Gr 4 events were considered DLTs unless there was evidence it was associated with disease progression. | Cycle 1 Day 1 to Day 21 (each cycle is 21 days) |
| Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Treatment-emergent AEs (TEAEs) are adverse events with an onset date during the on-treatment period. Adverse events will be graded according to NCI CTCAE Version 5.0 and coded using the current version of Medical Dictionary for Regulatory Activities (MedDRA) version 24.1. | Baseline up to 30 days after end of treatment, up to approximately 1 year 10 months post-treatment |
| Objective Response Rate (ORR) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Expansion) | Baseline up to 5 years post-treatment | |
| Duration of Response (DoR) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Expansion) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | The plasma PK parameters were estimated using standard noncompartmental methods. | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) |
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Inclusion Criteria:
Written informed consent
At least 20 years old in Japan or 18 years old in other countries at the time of signature of the informed consent form (ICF), following local regulatory requirements
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Has histopathologically documented unresectable and/or metastatic GIST meeting the criteria below:
Dose Escalation (Part 1): Participants should meet one of the following criteria:
Dose Expansion (Part 2) Cohort 1: Participants with GIST who have progressed on or are intolerant to IM and at least one post-IM treatment
Dose Expansion (Part 2) Cohort 2: Participants with GIST who have progressed on IM and had not received a post-IM treatment (2nd line)
Consents to provide fresh tumor biopsy tissue samples both before and on DS-6157a treatment for the measurement of GPR20 levels by immunohistochemistry and other biomarkers
Has a left ventricular ejection fraction (LVEF) ≥50% by either echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) within 28 days before study treatment
Has at least 1 measurable lesion based on RECIST Version 1.1 as assessed by the Investigator
Has adequate organ function within 7 days before the start of study treatment, defined as:
Has an adequate treatment washout period prior to start of study treatment, defined as:
Major surgery: ≥4 weeks (or 2 weeks for minor surgeries)
Radiation therapy: ≥3 weeks (or 2 weeks for palliative radiation excluding pelvic radiation)
Systemic anti-cancer therapy (except for anti-androgen for prostate cancer and bisphosphonate, denosumab, or medroxyprogesterone acetate for bone metastases):
Male participants with female partners of childbearing potential and female participants of child-bearing potential must agree to use a highly effective form of contraception, or avoid intercourse during and upon completion of the study and for at least 4 months (for males) and for at least 7 months (for females) after the last dose of study drug.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States | ||
| Washington University of St. Louis |
De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Dose Escalation (Part 1) was designed to establish the maximum tolerated dose and recommended dose of expansion (RDE) for DS-6157a. Dose-Expansion (Part 2) was expected to start at the RDE to further characterize the safety and tolerability, pharmacokinetics profile, and efficacy of DS-6157a; however, due to lower than anticipated efficacy in Part 1, the Sponsor decided to terminate the study prior to Dose Expansion. Efficacy analyses were limited in Part 1; no analyses in Part 2 were conducted.
A total of 34 participants who met all inclusion and no exclusion criteria were enrolled and received treatment at 5 clinic sites in the United States and Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Escalation: DS-6157a 1.6 mg/kg | Participants with advanced gastrointestinal stromal tumor (GIST) who received an intravenous (IV) infusion of DS-6157a 1.6 mg/kg every 3 weeks. |
| FG001 | Dose Escalation: DS-6157a 3.2 mg/kg | Participants with advanced GIST who received an IV infusion of DS-6157a 3.2 mg/kg every 3 weeks. |
| FG002 | Dose Escalation: DS-6157a 4.8 mg/kg | Participants with advanced GIST who received an IV infusion of DS-6157a 4.8 mg/kg every 3 weeks. |
| FG003 | Dose Escalation: DS-6157a 6.4 mg/kg | Participants with advanced GIST who received an IV infusion of DS-6157a 6.4 mg/kg every 3 weeks. |
| FG004 | Dose Escalation: DS-6157a 9.6 mg/kg | Participants with advanced GIST who received an IV infusion of DS-6157a 9.6 mg/kg every 3 weeks. |
| FG005 | Dose Escalation: DS-6157a 12.8 mg/kg | Participants with advanced GIST who received an IV infusion of DS-6157a 12.8 mg/kg every 3 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Demographic and baseline characteristics were assessed in the Safety Analysis Set.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Escalation: DS-6157a 1.6 mg/kg | Participants with advanced gastrointestinal stromal tumor (GIST) who received an intravenous (IV) infusion of DS-6157a 1.6 mg/kg every 3 weeks. |
| BG001 | Dose Escalation: DS-6157a 3.2 mg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Dose-limiting Toxicities (DLT) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | For hematologic toxicities, a DLT is defined as: Grade (Gr) 4 neutrophil count decreased lasting >7 days, Gr ≥3 febrile neutropenia, Gr ≥3 anemia requiring transfusion, Gr 4 anemia, Gr 4 platelet count decreased, Gr ≥3 platelet count decreased lasting >7 days or associated with clinically significant hemorrhage and/or requiring transfusion, and Gr 4 lymphocyte count decreased lasting ≥14 days. For non-hematologic, non-hepatic major organ toxicities, a DLT is all TEAEs of Gr ≥3 except: Gr 3 fatigue lasting <7 days, Gr 3 nausea, vomiting, diarrhea, or anorexia that has resolved to Gr ≤2 within 3 days with maximal medical management, Gr 3 isolated lab findings not associated with signs or symptoms including alkaline phosphatase increased, hyperuricemia, serum amylase increased, and lipase increased, and Gr 3 hyponatremia lasting <72 hours developed from Gr 1 at baseline. Symptomatic Gr 4 events were considered DLTs unless there was evidence it was associated with disease progression. | Dose-limiting toxicities were assessed in the Dose Limiting Toxicity Evaluable Set. | Posted | Count of Participants | Participants | Cycle 1 Day 1 to Day 21 (each cycle is 21 days) |
Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
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| 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: DS-6157a 1.6 mg/kg | Participants with advanced gastrointestinal stromal tumor (GIST) who received an intravenous (IV) infusion of DS-6157a 1.6 mg/kg every 3 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Daiichi Sankyo | 908-992-6400 | CTRinfo@dsi.com |
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| 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 | Aug 17, 2021 | May 31, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Baseline up to 5 years post-treatment |
| Disease Control Rate (DCR) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Expansion) | Baseline up to 5 years post-treatment |
| Progression-free Survival (PFS) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Expansion) | Baseline up to 5 years post-treatment |
| Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for MAAA-1181a Following Intravenous Administration of DS-6157a | The plasma PK parameters were estimated using standard noncompartmental methods. | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) |
| Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | The plasma PK parameters were estimated using standard noncompartmental methods. | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) |
| Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for MAAA-1181a Following Intravenous Administration of DS-6157a | The plasma PK parameters were estimated using standard noncompartmental methods. | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) |
| Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | The plasma PK parameters were estimated using standard noncompartmental methods. | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) |
| Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | The plasma PK parameters were estimated using standard noncompartmental methods. | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) |
| Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for MAAA-1181a Following Intravenous Administration of DS-6157a | The plasma PK parameters were estimated using standard noncompartmental methods. | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) |
| Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | The plasma PK parameters were estimated using standard noncompartmental methods. | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) |
| Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for MAAA-1181a Following Intravenous Administration of DS-6157a | The plasma PK parameters were estimated using standard noncompartmental methods. | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) |
| Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | The plasma PK parameters were estimated using standard noncompartmental methods. | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) |
| Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Based on Response Evaluation Criteria In Solid Tumors guidelines, complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions). | Baseline up to long-term follow up (defined as until the start of a new anti-cancer treatment, PD, death, lost to follow up, withdrawal of consent, or at the discretion of the Investigator, whichever occurs first), up to approximately 1 year 10 months. |
| Progression-free Survival (PFS) Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Progression-free survival (PFS) is defined as the time from randomization/start of study treatment to the date of event defined as the first documented radiological progression or death due to any cause. | Baseline up to the date of the first documented radiological progression or death due to any cause, whichever occurs first, up to approximately 1 year 10 months |
| Objective Response Rate (ORR) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Baseline up to 5 years post-treatment |
| Duration of Response (DoR) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Baseline up to 5 years post-treatment |
| Disease Control Rate (DCR) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Baseline up to 5 years post-treatment |
| Number of Participants With Anti-drug Antibodies Against DS-6157a Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) | Baseline up to 5 years post-treatment |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| MD Anderson | Houston | Texas | 77030 | United States |
| National Cancer Center Hospital East | Tokyo | 277-8577 | Japan |
| Clinical progression |
|
| Other |
|
| Physician Decision |
|
| Progressive disease |
|
| Withdrawal by patient |
|
Participants with advanced GIST who received an IV infusion of DS-6157a 3.2 mg/kg every 3 weeks.
| BG002 | Dose Escalation: DS-6157a 4.8 mg/kg | Participants with advanced GIST who received an IV infusion of DS-6157a 4.8 mg/kg every 3 weeks. |
| BG003 | Dose Escalation: DS-6157a 6.4 mg/kg | Participants with advanced GIST who received an IV infusion of DS-6157a 6.4 mg/kg every 3 weeks. |
| BG004 | Dose Escalation: DS-6157a 9.6 mg/kg | Participants with advanced GIST who received an IV infusion of DS-6157a 9.6 mg/kg every 3 weeks. |
| BG005 | Dose Escalation: DS-6157a 12.8 mg/kg | Participants with advanced GIST who received an IV infusion of DS-6157a 12.8 mg/kg every 3 weeks. |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) | Treatment-emergent AEs (TEAEs) are adverse events with an onset date during the on-treatment period. Adverse events will be graded according to NCI CTCAE Version 5.0 and coded using the current version of Medical Dictionary for Regulatory Activities (MedDRA) version 24.1. | Treatment-emergent adverse events (TEAEs) were assessed in the Safety Analysis Set. | Posted | Count of Participants | Participants | Baseline up to 30 days after end of treatment, up to approximately 1 year 10 months post-treatment |
|
|
|
| Primary | Objective Response Rate (ORR) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Expansion) | This outcome measure was not assessed due to early study termination. | Posted | Baseline up to 5 years post-treatment |
|
|
| Primary | Duration of Response (DoR) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Expansion) | This outcome measure was not assessed due to early study termination. | Posted | Baseline up to 5 years post-treatment |
|
|
| Primary | Disease Control Rate (DCR) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Expansion) | This outcome measure was not assessed due to early study termination. | Posted | Baseline up to 5 years post-treatment |
|
|
| Primary | Progression-free Survival (PFS) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Expansion) | This outcome measure was not assessed due to early study termination. | Posted | Baseline up to 5 years post-treatment |
|
|
| Secondary | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | The plasma PK parameters were estimated using standard noncompartmental methods. | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | day*ug/mL | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) |
|
|
|
| Secondary | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for MAAA-1181a Following Intravenous Administration of DS-6157a | The plasma PK parameters were estimated using standard noncompartmental methods. | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | day*ng/mL | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) |
|
|
|
| Secondary | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | The plasma PK parameters were estimated using standard noncompartmental methods. | Pharmacokinetic parameters were assessed in participants with available data in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | day*ug/mL | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) |
|
|
|
| Secondary | Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for MAAA-1181a Following Intravenous Administration of DS-6157a | The plasma PK parameters were estimated using standard noncompartmental methods. | Pharmacokinetic parameters were assessed in participants with available data in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | day*ng/mL | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) |
|
|
|
| Secondary | Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | The plasma PK parameters were estimated using standard noncompartmental methods. | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | hours | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) |
|
|
|
| Secondary | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | The plasma PK parameters were estimated using standard noncompartmental methods. | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | ug/mL | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) |
|
|
|
| Secondary | Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for MAAA-1181a Following Intravenous Administration of DS-6157a | The plasma PK parameters were estimated using standard noncompartmental methods. | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) |
|
|
|
| Secondary | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a | The plasma PK parameters were estimated using standard noncompartmental methods. | Pharmacokinetic parameters were assessed in participants with available data in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | ug/mL | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) |
|
|
|
| Secondary | Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for MAAA-1181a Following Intravenous Administration of DS-6157a | The plasma PK parameters were estimated using standard noncompartmental methods. | Pharmacokinetic parameters were assessed in participants with available data in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) |
|
|
|
| Secondary | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a | The plasma PK parameters were estimated using standard noncompartmental methods. | Pharmacokinetic parameters were assessed in participants with available data in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | day | Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days) |
|
|
|
| Secondary | Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Based on Response Evaluation Criteria In Solid Tumors guidelines, complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions). | Best overall response was assessed in the Full Analysis Set. | Posted | Count of Participants | Participants | Baseline up to long-term follow up (defined as until the start of a new anti-cancer treatment, PD, death, lost to follow up, withdrawal of consent, or at the discretion of the Investigator, whichever occurs first), up to approximately 1 year 10 months. |
|
|
|
| Secondary | Progression-free Survival (PFS) Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | Progression-free survival (PFS) is defined as the time from randomization/start of study treatment to the date of event defined as the first documented radiological progression or death due to any cause. | Progression-free survival was assessed in participants with available data (events) in the Full Analysis Set. | Posted | Median | 95% Confidence Interval | months | Baseline up to the date of the first documented radiological progression or death due to any cause, whichever occurs first, up to approximately 1 year 10 months |
|
|
|
| Secondary | Objective Response Rate (ORR) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | This outcome measure was not assessed due to early study termination. | Posted | Baseline up to 5 years post-treatment |
|
|
| Secondary | Duration of Response (DoR) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | This outcome measure was not assessed due to early study termination. | Posted | Baseline up to 5 years post-treatment |
|
|
| Secondary | Disease Control Rate (DCR) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation) | This outcome measure was not assessed due to early study termination. | Posted | Baseline up to 5 years post-treatment |
|
|
| Secondary | Number of Participants With Anti-drug Antibodies Against DS-6157a Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) | This outcome measure was not assessed due to early study termination. | Posted | Baseline up to 5 years post-treatment |
|
|
| 1 |
| 4 |
| 1 |
| 4 |
| 4 |
| 4 |
| EG001 | Dose Escalation: DS-6157a 3.2 mg/kg | Participants with advanced GIST who received an IV infusion of DS-6157a 3.2 mg/kg every 3 weeks. | 0 | 4 | 1 | 4 | 4 | 4 |
| EG002 | Dose Escalation: DS-6157a 4.8 mg/kg | Participants with advanced GIST who received an IV infusion of DS-6157a 4.8 mg/kg every 3 weeks. | 2 | 5 | 1 | 5 | 5 | 5 |
| EG003 | Dose Escalation: DS-6157a 6.4 mg/kg | Participants with advanced GIST who received an IV infusion of DS-6157a 6.4 mg/kg every 3 weeks. | 2 | 13 | 2 | 13 | 13 | 13 |
| EG004 | Dose Escalation: DS-6157a 9.6 mg/kg | Participants with advanced GIST who received an IV infusion of DS-6157a 9.6 mg/kg every 3 weeks. | 1 | 6 | 3 | 6 | 6 | 6 |
| EG005 | Dose Escalation: DS-6157a 12.8 mg/kg | Participants with advanced GIST who received an IV infusion of DS-6157a 12.8 mg/kg every 3 weeks. | 0 | 2 | 1 | 2 | 2 | 2 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Varices oesophageal | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hyperparathyroidism | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 24.1 | Systematic Assessment |
|
| Eye disorder | Eye disorders | MedDRA 24.1 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 24.1 | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Varices oesophageal | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Infusion site extravasation | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Portal hypertension | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Alanine aminotransferase | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Aspartate aminotransferase | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Bilirubin conjugated increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Muscle fatigue | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Taste disorder | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
Not provided
Not provided
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| Anemia |
|
| Febrile neutropenia |
|
| Neutropenia |
|
| Palpitations |
|
| Sinus tachycardia |
|
| Tachycardia |
|
| Hypothyroidism |
|
| Eye disorder |
|
| Lacrimation increased |
|
| Vitreous floaters |
|
| Abdominal distension |
|
| Abdominal pain |
|
| Abdominal pain lower |
|
| Abdominal pain upper |
|
| Anal fissure |
|
| Ascites |
|
| Constipation |
|
| Diarrhea |
|
| Dyspepsia |
|
| Flatulence |
|
| Gastritis |
|
| Gastrooesophageal reflux disease |
|
| Haematemesis |
|
| Intestinal perforation |
|
| Nausea |
|
| Upper gastrointestinal haemorrhage |
|
| Varices oesophageal |
|
| Vomiting |
|
| Asthenia |
|
| Chest discomfort |
|
| Fatigue |
|
| Influenza like illness |
|
| Injection site reaction |
|
| Malaise |
|
| Mucosal inflammation |
|
| Oedema peripheral |
|
| Pyrexia |
|
| Hepatic function abnormal |
|
| Portal hypertension |
|
| Portal vein thrombosis |
|
| Bronchitis |
|
| COVID-19 |
|
| Eye infection |
|
| Herpes zoster |
|
| Pneumonia |
|
| Upper respiratory tract infection |
|
| Contusion |
|
| Fall |
|
| Infusion related reaction |
|
| Procedural pain |
|
| Alanine aminotransferase increased |
|
| Aspartate aminotransferase increased |
|
| Blood albumin decreased |
|
| Blood alkaline phosphatase increased |
|
| Blood creatinine increased |
|
| Blood potassium decreased |
|
| Electrocardiogram QT prolonged |
|
| Lymphocyte count decreased |
|
| Neutrophil count decreased |
|
| Platelet count decreased |
|
| Protein total decreased |
|
| Weight decreased |
|
| White blood cell count decreased |
|
| Decreased appetite |
|
| Dehydration |
|
| Hyperglycaemia |
|
| Hyperkalaemia |
|
| Hyperphosphataemia |
|
| Hyperuricaemia |
|
| Hypoalbuminaemia |
|
| Hypocalcaemia |
|
| Hypoglycaemia |
|
| Hypokalaemia |
|
| Hyponatraemia |
|
| Hypophosphataemia |
|
| Athralgia |
|
| Arthritis |
|
| Back pain |
|
| Flank pain |
|
| Muscle fatigue |
|
| Muscle spasms |
|
| Muscular weakness |
|
| Myalgia |
|
| Disturbance in attention |
|
| Dizziness |
|
| Dysarthria |
|
| Dysgeusia |
|
| Headache |
|
| Hyperaesthesia |
|
| Peripheral sensory neuropathy |
|
| Taste disorder |
|
| Anxiety |
|
| Confusional state |
|
| Delirium |
|
| Insomnia |
|
| Haematuria |
|
| Pollakiuria |
|
| Proteinuria |
|
| Renal disorder |
|
| Urinary tract obstruction |
|
| Pelvic pain |
|
| Cough |
|
| Dyspnoea |
|
| Dyspnoea exertional |
|
| Epistaxis |
|
| Hiccups |
|
| Pulmonary embolism |
|
| Rhinorrhoea |
|
| Sleep apnoea syndrome |
|
| Alopecia |
|
| Dry skin |
|
| Hyperhidrosis |
|
| Rash maculo-papular |
|
| Rash papular |
|
| Skin fissures |
|
| Deep vein thrombosis |
|
| Hot flush |
|
| Hypertension |
|
| Hypotension |
|
|
| DS-6157a: Cycle 3 |
|
|
| Total anti-GPR20 antibody: Cycle 1 |
|
|
| Total anti-GPR20 antibody: Cycle 3 |
|
|
|
| MAAA-1181a: Cycle 3 |
|
|
|
| DS-6157a: Cycle 3 |
|
|
| Total anti-GPR20 antibody: Cycle 1 |
|
|
| Total anti-GPR20 antibody: Cycle 3 |
|
|
|
| MAAA-1181a: Cycle 3 |
|
|
|
| DS-6157a: Cycle 3 |
|
|
| Total anti-GPR20 antibody: Cycle 1 |
|
|
| Total anti-GPR20 antibody: Cycle 3 |
|
|
| MAAA-1181a: Cycle 1 |
|
|
| MAAA-1181a: Cycle 3 |
|
|
|
| DS-6157a: Cycle 3 |
|
|
| Total anti-GPR20 antibody: Cycle 1 |
|
|
| Total anti-GPR20 antibody: Cycle 3 |
|
|
|
| MAAA-1181a: Cycle 3 |
|
|
|
| DS-6157a: Cycle 3 |
|
|
| Total anti-GPR20 antibody: Cycle 1 |
|
|
| Total anti-GPR20 antibody: Cycle 3 |
|
|
|
| MAAA-1181a: Cycle 3 |
|
|
|
| DS-6157a: Cycle 3 |
|
|
| Total anti-GPR20 antibody: Cycle 1 |
|
|
| Total anti-GPR20 antibody: Cycle 3 |
|
|
| MAAA-1181a: Cycle 1 |
|
|
| MAAA-1181a: Cycle 3 |
|
|
| Partial response (PR) |
|
| Stable disease (SD) |
|
| Progressive disease (PD) |
|
| Not evaluable (NE) |
|