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

Not Applicable

Not yet recruiting

• Conditions: Endometrial Cancer; Recurrent or Progressive Endometrial Cancer
• Interventions: Drug: Rina-S; Drug: IC

• Registration Number: NCT07166094
• Lead Sponsor: Genmab

Brief 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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-09
• Study First Submitted QC: 2025-09-09
• Study First Posted: 2025-09-10
• Last Update Submitted: 2025-09-12
• Last Update Posted: 2025-09-15
• Study Start: 2025-10-15
• Primary Completion: 2028-11
• Study Completion: 2029-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 544

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rina-S	Rina-S	Participants will receive Rina-S on Day 1 once every 3 weeks (Q3W).
IC	IC	Participants will receive one of the following chemotherapies at the discretion of the investigator: * Paclitaxel on Days 1, 8, and 15 every 4 weeks (Q4W). * Doxorubicin on Day 1 Q3W.

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) per Response Criteria in Solid Tumors (RECIST) v1.1, as Determined by Investigator Assessment	Up to approximately 3 years
Overall Survival (OS)	Up to approximately 3 years

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR), per RECIST v1.1, as Determined by Investigator Assessment	Up to approximately 3 years
ORR, per RECIST v1.1, as Determined by BICR	Up to approximately 3 years
PFS, per RECIST v1.1, as Determined by Blinded Independent Central Review (BICR)	Up to approximately 3 years
Duration of Objective Response (DOR), per RECIST v1.1, as Determined by Investigator Assessment	Up to approximately 3 years
DOR, per RECIST v1.1, as Determined by BICR	Up to approximately 3 years
Number of Participants with Treatment-emergent Adverse Events (TEAEs)	Up to approximately 3 years
Change from Baseline in Global Health Status/Quality of Life (GHS/Qol)	Baseline up to approximately 3 years
Time to Deterioration (TTD) in GHS/Qol	Up to approximately 3 years