A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors
This clinical trial will evaluate DS-6000a in participants with advanced renal cell carcinoma (RCC) and ovarian cancer (OVC). The main goals of this study will be to investigate the recommended dose of DS-6000a that can be given safely to participants, assess the side effects of DS-6000a, and evaluate the effectiveness of DS-6000a.
- Renal Cell Carcinoma
- Ovarian Tumor
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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 study start - 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.
- Has had prior treatment with other CDH6-targeted agents - Has had prior treatment with an ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan, DS-1062a, DS-7300a) - Has history or current presence of CNS metastases except for participants who have completed radiotherapy or surgery ≥2 weeks before the start of treatment and have no evidence of disease progression in the CNS and no requirement for chronic corticosteroid therapy within 2 weeks before the start of treatment - Has multiple primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years) - Has a history of myocardial infarction or unstable angina within 6 months before study treatment - Has a medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a serious cardiac arrhythmia requiring treatment - Lung-specific intercurrent clinically significant illnesses - Has an uncontrolled infection requiring systemic therapy
- Phase 1
- Study Type
- Intervention Model
- Sequential Assignment
- Primary Purpose
- None (Open Label)
|Participants with ovarian cancer (OVC) or renal cell carcinoma (RCC) will receive an intravenous infusion of DS-6000a (starting dose 1.6 mg/kg).||
Dose Expansion: Cohort B-1
|Participants with RCC will receive an intravenous infusion of DS-6000a at the RDE.||
Dose Expansion: Cohort B-2
|Participants with OVC will receive an intravenous infusion of DS-6000a at the RDE.||
- Daiichi Sankyo, Inc.
Study Contact(US sites) Daiichi Sankyo Contact for Clinical Trial Information
DS-6000a is an antibody drug conjugate that specifically binds to CDH6 on the cell surface of target cells, which leads to the internalization of DS-6000a into the cells. MAAA-1181a that is released from DS-6000a in the target cells inhibits cell replication and induces cell apoptosis. This study will evaluate DS-6000a given as a single agent once every 21 days. The dose escalation phase will enroll participants with OVC and RCC, and is designed to assess the safety and tolerability of DS-6000a and to determine the maximum tolerated dose (MTD)/recommended dose for expansion (RDE). Following the selection of the RDE, the dose expansion phase will be initiated to evaluate clinical activity of DS-6000a.