Status:
ACTIVE_NOT_RECRUITING
A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors
Lead Sponsor:
Daiichi Sankyo
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Renal Cell Carcinoma
Ovarian Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 in...
Detailed Description
R-DXd is an antibody drug conjugate that specifically binds to CDH6 on the cell surface of target cells, which leads to the internalization of R-DXd into the cells. MAAA-1181a that is released from R-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT04707248
Start Date
December 22 2020
End Date
June 30 2026
Last Update
July 28 2025
Active Locations (13)
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1
Arizona Oncology Associates, PC HOPE (A)A HOPE)
Tucson, Arizona, United States, 85711
2
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
3
Florida Cancer Lake Mary
Lake Mary, Florida, United States, 32746
4
Oklahoma University
Oklahoma City, Oklahoma, United States, 73104