NCT07166094

Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer

A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 544 (estimated)
• Sponsor: Genmab · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare how well Rina-S (GEN1184) works compared to treatment of physician's choice (paclitaxel or doxorubicin) that are considered standard medical care for the treatment of recurrent or progressive endometrial cancer (EC) following prior therapy. There is an equal (50:50) chance of getting either Rina-S or a chemotherapy agent as treatment in this study. The study duration will be approximately 3 years. The treatment duration will be different for every participant, but an average of 4 to 6 months is expected. All participants will receive active drug; no one will be given placebo. Participation in the study will require visits to the study site(s).

Detailed description

This is a global, open-label, randomized Phase 3 study in approximately 544 participants with recurrent or progressive EC following prior therapy. Participants will be randomized in a 1:1 ratio to receive treatment with Rina-S vs investigator's choice (IC) (paclitaxel or doxorubicin). Investigators must select one of the IC treatment options for each participant prior to randomization so that this may be used for treatment assignment if the participant is randomized to the IC arm.

Conditions

• Endometrial Cancer
• Recurrent or Progressive Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Rina-S	Intravenous (IV) infusion.
DRUG	IC	* Paclitaxel: IV infusion * Doxorubicin: IV bolus injection/infusion

Timeline

• Start date: 2025-11-28
• Primary completion: 2028-11-01
• Completion: 2029-02-01
• First posted: 2025-09-10
• Last updated: 2026-03-03

Locations

51 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study