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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

NCT04707248

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