A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors

Running, not enrolling · Phase 1

Conditions studied: Renal Cell Carcinoma, Ovarian Tumor

In brief

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.

Key facts

Study ID

NCT04707248

Run by

Daiichi Sankyo

People needed

179

Starts

2020-12-22

Expected to finish

2026-06-30

Last updated by the study team

2025-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 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 start of study treatment
• 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

Where it is running

• Arizona Oncology Associates, PC HOPE (A)A HOPE) — Tucson, Arizona, United States
• Rocky Mountain Cancer Center — Denver, Colorado, United States
• Florida Cancer Lake Mary — Lake Mary, Florida, United States
• Oklahoma University — Oklahoma City, Oklahoma, United States
• SCRI Oncology Partners — Nashville, Tennessee, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• National Cancer Center Hospital — Chuo Ku, Tokyo, Japan
• National Cancer Center Hospital East — Kashiwa-shi, Tokyo, Japan
• 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

Full record on ClinicalTrials.gov

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