A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
DS-6000a: Intravenous administration at doses starting at 1.6 mg/kg on Day 1 of Cycle 1
DS-6000a: Intravenous administration at RDE on Day 1 of Cycle 1
Study summary
This clinical trial will evaluate raludotatug deruxtecan (R-DXd; 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 R-DXd that can be given safely to participants, assess the adverse events of R-DXd, and evaluate the effectiveness of R-DXd.
Eligibility
Primary outcome measure(s)
- Number of Participants With Dose-limiting toxicities (DLTs) — 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 — 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) — From start of treatment (Cycle 1, Day 1) up to disease progression, up to approximately 52 months (each cycle is 21 days)
ORR is defined as the proportion of participants with best overall response (BOR) of complete response (CR) or partial response (PR).
Trial sites (13)
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Oncology Associates, PC HOPE (A)A HOPE) | Tucson | Arizona | |
| Rocky Mountain Cancer Center | Denver | Colorado | |
| Florida Cancer Lake Mary | Lake Mary | Florida | |
| Oklahoma University | Oklahoma City | Oklahoma | |
| SCRI Oncology Partners | Nashville | Tennessee | |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | |
| National Cancer Center Hospital | Chuo Ku | Tokyo | |
| National Cancer Center Hospital East | Kashiwa-shi | Tokyo | |
| National Hospital Organization Kyusyu Cancer Center | Fukuoka | Japan | |
| The Cancer Institute Hospital of Japanese Foundation for Cancer Research | Kōtoku | Japan | |
| National Hospital Organization Shikoku Cancer Center | Matsuyama | Japan | |
| Shizuoka Cancer Center | Nakatogari | Japan | |
| Saitama Medical University International Medical Center | Saitama | Japan |
More Daiichi Sankyo trials in Japan
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04707248 on ClinicalTrials.gov ↗ ← All trials in Japan