A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors
NCT ID: NCT04707248
Last Updated: 2025-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
179 participants
INTERVENTIONAL
2020-12-22
2026-06-30
Brief Summary
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Detailed Description
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This study will evaluate R-DXd 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 R-DXd 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 R-DXd.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
Participants with ovarian cancer (OVC) or renal cell carcinoma (RCC) will receive an intravenous infusion of R-DXd (starting dose 1.6 mg/kg).
DS-6000a
Intravenous administration at doses starting at 1.6 mg/kg on Day 1 of Cycle 1
Dose Expansion: Cohort B-1
Participants with RCC will receive an intravenous infusion of R-DXd at the RDE. Enrollment has ended for this cohort.
DS-6000a
Intravenous administration at RDE on Day 1 of Cycle 1
Dose Expansion: Cohort B-2
Participants with OVC will receive an intravenous infusion of R-DXd at the RDE.
DS-6000a
Intravenous administration at RDE on Day 1 of Cycle 1
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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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
Countries
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Other Identifiers
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DS6000-A-U101
Identifier Type: -
Identifier Source: org_study_id
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