R-DXd for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+82 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Daiichi Sankyo, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This study will evaluate the safety and efficacy of R-DXd therapy in participants with ovarian, peritoneal, or fallopian tube cancer

Eligibility Criteria

This trial is for adults with high-grade ovarian, primary peritoneal, or fallopian tube cancer that's resistant to platinum-based treatments. Participants must have a tumor suitable for biopsy and agree to provide tissue samples. They should have had prior therapy including bevacizumab unless unsuitable due to intolerance.

Inclusion Criteria

I am at least 18 years old or the legal adult age in my country.

Required baseline local laboratory data (within 7 days before start of study drug administration)

Sign and date the informed consent form prior to the start of any study-specific qualification procedures

+12 more

Exclusion Criteria

Inadequate washout period before Cycle 1 Day 1

My ovarian cancer is of a specific type (clear cell, mucinous, sarcomatous, mixed, or low-grade).

I do not have active brain tumors, spinal cord compression, or cancer in the lining of my brain and spinal cord.

+17 more

Participant Groups

The study tests R-DXd's safety and effectiveness against other drugs like Gemcitabine, Paclitaxel, Topotecan, PLD in patients with certain types of cancer. It aims to see if R-DXd can help where standard treatments haven't worked well.

5Treatment groups

Experimental Treatment

Active Control

Group I: Part B: R-DXd RP3D Q3WExperimental Treatment1 Intervention

Participants will be randomized to receive intravenous R-DXd administered at the Recommended Phase 3 Dose (RP3D) every 3 weeks (Q3W).

Group II: Part A: R-DXd 6.4 mg/kg Q3WExperimental Treatment1 Intervention

Participants will be randomized to receive intravenous R-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).

Group III: Part A: R-DXd 5.6 mg/kg Q3WExperimental Treatment1 Intervention

Participants will be randomized to receive intravenous R-DXd administered at a dose of 5.6 mg/kg every 3 weeks (Q3W).

Group IV: Part A: R-DXd 4.8mg/kg Q3WExperimental Treatment1 Intervention

Participants will be randomized to receive intravenous R-DXd administered at a dose of 4.8 mg/kg every 3 weeks (Q3W).

Group V: Part B: Investigator's ChoiceActive Control4 Interventions

Participants will be randomized to receive intravenous treatment with investigator's choice of paclitaxel, pegylated liposomal doxorubicin (PLD), gemcitabine, or topotecan.