NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors
A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors
Active Not RecruitingPhase 1
Sponsor: Daiichi Sankyo
Conditions: Renal Cell Carcinoma, Ovarian Tumor
Interventions: DS-6000a, DS-6000a
Countries: United States, Japan
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 overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
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
Locations (13)
- Tucson, Arizona, United States
- Denver, Colorado, United States
- Lake Mary, Florida, United States
- Oklahoma City, Oklahoma, United States
- Nashville, Tennessee, United States
- Nashville, Tennessee, United States
- Chuo Ku, Tokyo, Japan
- Kashiwa-shi, Tokyo, Japan
- Fukuoka, Japan
- Kōtoku, Japan
- Matsuyama, Japan
- Nakatogari, Japan
- Saitama, Japan