Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer
NCT07166094 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 660
Last updated 2026-05-06
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).
Conditions
- Endometrial Cancer
- Recurrent or Progressive Endometrial Cancer
Interventions
- DRUG
-
Rina-S
Intravenous (IV) infusion.
- DRUG
-
IC
* Paclitaxel: IV infusion * Doxorubicin: IV bolus injection/infusion
Sponsors & Collaborators
-
Genmab
lead INDUSTRY
Principal Investigators
-
Study Official · Genmab
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-28
- Primary Completion
- 2029-08-31
- Completion
- 2029-11-30
- FDA Drug
- Yes
Countries
- United States
- Australia
- Belgium
- Canada
- Finland
- Japan
- Norway
- Poland
- Puerto Rico
- Spain
Study Locations
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