A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors
Phase I, Two-Part, Multi-Center, First-in-Human Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors
Sponsor: Daiichi Sankyo + Merck Sharp & Dohme LLC
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Number of Participants With Dose-limiting toxicities (DLTs)
Time frame: Day 1 to Day 21 in Cycle 1 (each cycle is 21 days)
Number of Participants Reporting Treatment-emergent Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest
Time frame: From start of treatment up to 40 days after last dose, up to approximately 52 months
Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (Dose Expansion)
Time frame: From start of treatment (Cycle 1, Day 1) up to disease progression, up to approximately 52 months (each cycle is 21 days)
Secondary Endpoints
Pharmacokinetic Analysis Area Under the Plasma Concentration-Time Curve from Time Zero to 21 Days (AUC 21d) for R-DXd and its Metabolites
Pharmacokinetic Analysis Area Under the Plasma Concentration-Time Curve Up to the Last Quantifiable Time (AUClast) for R-DXd and its Metabolites
Pharmacokinetic Analysis Maximum Plasma Concentration (Cmax) for R-DXd and its Metabolites
Eligibility Criteria
Inclusion Criteria: * Written informed consent * At least 18 years of age * Eastern Cooperative Oncology Group Performance Status score of 0 or 1 * Availability of archived tumor tissue samples * Has a left ventricular ejection fraction (LVEF) ≥50% by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before start of study treatment * Has adequate organ function within 7 days before the start of study treatment * Has an adequate treatment washout period prior to start of study treatment * 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: * Has had prior treatment with other CDH6-targeted agents * Has had prior treatment with an ADC that…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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