DS-6000a for Kidney and Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+14 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Daiichi Sankyo

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing a new medicine called R-DXd for patients with advanced kidney and ovarian cancers. The medicine targets cancer cells, gets inside them, and releases a drug that stops their growth and kills them. The study aims to find the safest dose and see how well it works.

Eligibility Criteria

This trial is for adults with advanced kidney cancer or ovarian tumors who can consent, use effective contraception, have a good performance status (able to carry out daily activities), and proper heart function. They must not have had certain previous cancer treatments, multiple cancers unless cured over 3 years ago, recent serious heart issues, significant lung illnesses, uncontrolled infections or brain metastases.

Inclusion Criteria

I am fully active or can carry out light work.

Has an adequate treatment washout period prior to start of study treatment

I am 18 years old or older.

+5 more

Exclusion Criteria

I am currently fighting an infection that needs treatment.

I had a heart attack or unstable chest pain within the last 6 months.

I have been treated with a specific type of cancer drug related to trastuzumab.

+5 more

Participant Groups

The study tests DS-6000a (Raludotatug Deruxtecan) in patients with advanced renal cell carcinoma and ovarian cancer. It aims to find the safest dose of R-DXd that participants can take while also evaluating its side effects and effectiveness against these cancers.

3Treatment groups

Experimental Treatment

Group I: Dose Expansion: Cohort B-2Experimental Treatment1 Intervention

Participants with OVC will receive an intravenous infusion of R-DXd at the RDE.

Group II: Dose Expansion: Cohort B-1Experimental Treatment1 Intervention

Participants with RCC will receive an intravenous infusion of R-DXd at the RDE. Enrollment has ended for this cohort.

Group III: Dose EscalationExperimental Treatment1 Intervention

Participants with ovarian cancer (OVC) or renal cell carcinoma (RCC) will receive an intravenous infusion of R-DXd (starting dose 1.6 mg/kg).