A Phase 2/3, Multicenter, Randomized Study of Raludotatug Deruxtecan (R-DXd), a CDH6-directed Antibody-drug Conjugate, in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Daiichi Sankyo

Summary

This study will evaluate the safety and efficacy of R-DXd therapy in participants with ovarian, peritoneal, or fallopian tube cancer.

Description

This study will focus on R-DXd in participants with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer. R-DXd is an antibody-drug conjugate that specifically binds to CDH6, which is overexpressed in tumor cells. The Phase 2 dose-optimization part of the study (Part A) intends to define the recommended dose based on safety and efficacy, while the Phase 3 (Part B) part of the study will compare R-DXd with Investigator's choice of chemotherapy and further evaluate efficacy.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Sign and date the informed consent form prior to the start of any study-specific qualification procedures. * Age ≥18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed. * Participants with histologically or cytologically documented high-grade serous ovarian cancer (OVC), high-grade endometrioid OVC, primary peritoneal cancer, or fallopian tube cancer. * For Phase 2 (Part A) Participants must have at least 1 lesion, not previously irradiated, amenable to biopsy, and must consent to provide a pretreatment biopsy and…

Interventions

Drug
R-DXd
R-DXd will be administered as an intravenously (IV) infusion
Drug
Paclitaxel
Paclitaxel will be administered as an IV infusion
Drug
Topotecan
Topotecan will be administered as an IV infusion
Drug
PLD
PLD will be administered as an IV infusion

Locations (120)

Alaska Women's Cancer Care
Anchorage, Alaska
Yale University School of Medicine
New Haven, Connecticut
Sylvester Comprehensive Cancer Center at Lennar
Coral Gables, Florida
Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida
Florida Cancer Specialists
Lake Mary, Florida
Sylvester Cancer Center
Miami, Florida