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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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
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
Official registry record
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.
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