NCT04707248Active, not recruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 179 (actual)
- First submitted
- 16 Dec 2020
- Start date
- Dec 2020
- Primary completion date
- Dec 2026
- Lead sponsor
- Daiichi Sankyo
- Diseases
- Kidney cancer, Ovarian cancer
- NCT number
- NCT04707248
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 179
- From Dec 2020 to the primary completion date, Dec 2026
- 13 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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, datopotamab deruxtecan, ifinatamab deruxtecan, DS-3939)
- Has history or current presence of CNS metastases except for participants who have completed radiotherapy or surgery ≥2 weeks before the start of study 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 study treatment
- Has a history of myocardial infarction or unstable angina within 6 months before start of study treatment
Other illness
- Has a medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a cardiac arrhythmia requiring treatment
- Lung-specific intercurrent clinically significant illnesses
- Has an uncontrolled infection requiring systemic therapy
Age
- 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)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chuo Ku | Japan | Unknown status |
| National Hospital Organization Kyusyu Cancer Center Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Unknown status |
| The Cancer Institute Hospital of Japanese Foundation for Cancer Research Coordinator of this site? Confirm its status | Kōtoku | Japan | Unknown status |
| National Hospital Organization Shikoku Cancer Center Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| Shizuoka Cancer Center Coordinator of this site? Confirm its status | Nakatogari | Japan | Unknown status |
| Saitama Medical University International Medical Center Coordinator of this site? Confirm its status | Saitama | Japan | Unknown status |
| Rocky Mountain Cancer Center Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Florida Cancer Lake Mary Coordinator of this site? Confirm its status | Lake Mary | United States | Unknown status |
| Vanderbilt-Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Oklahoma University Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Arizona Oncology Associates, PC HOPE (A)A HOPE) Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.