drugset / Trial / NCT07166094

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

NCT07166094

Phase 3 Recruiting 660 enrolled Genmab
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2025-11-28
Primary completion
2029-08
Completion
2029-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxorubicin Other / unclassified Intravenous
Subject Paclitaxel Small molecule Intravenous
Subject Rina-S Unknown Intravenous

Indications