NCT06161025

A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 860 (estimated)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Solid Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-02-27
• Primary completion: 2028-02-29
• Completion: 2030-04-30
• First posted: 2023-12-07
• Last updated: 2026-01-12

Locations

120 sites across 15 countries: United States, Australia, Canada, China, Czechia, France, Germany, Italy, Japan, Poland, Portugal, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study