For Healthcare Professionals

A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors

clipboard-pencil

About the study

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 side effects of R-DXd, and evaluate the effectiveness of R-DXd.
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Written informed consent
  2. At least 18 years of age
  3. Eastern Cooperative Oncology Group Performance Status score of 0 or 1
  4. Availability of archived tumor tissue samples
  5. 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
  6. Has adequate organ function within 7 days before the start of study treatment
  7. Has an adequate treatment washout period prior to start of study treatment
  8. 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

Exclusion Criteria:

  1. Has had prior treatment with other CDH6-targeted agents
  2. Has had prior treatment with an ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan, DS-1062a, DS-7300a)
  3. 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
  4. 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)
  5. Has a history of myocardial infarction or unstable angina within 6 months before start of study treatment
  6. Has a medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a serious cardiac arrhythmia requiring treatment
  7. Lung-specific intercurrent clinically significant illnesses
  8. Has an uncontrolled infection requiring systemic therapy
pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Renal Cell Carcinoma,Ovarian Tumor

Age (in years)

18+

Phase

Phase 1

Participants needed

140

Est. Completion Date

Oct 31, 2024

Treatment type

Interventional


Sponsor

Daiichi Sankyo, Inc.

ClinicalTrials.gov identifier

NCT04707248

Study number

DS6000-A-U101

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
Vector

Interested?

Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.