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

Conditions

• Endometrial Cancer
• Recurrent or Progressive Endometrial Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rina-S — DRUG
  Intravenous (IV) infusion.
• IC — DRUG
  * Paclitaxel: IV infusion * Doxorubicin: IV bolus injection/infusion

Study Details

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).

Key Dates

First listed

Sep 10, 2025

Start date

Nov 28, 2025

Status verified

Jul 2026

Primary completion

Aug 31, 2029

Completion

Nov 30, 2029

Study Design

Enrollment

660 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Rina-S
  Participants will receive Rina-S on Day 1 once every 3 weeks (Q3W).
• Active Comparator: 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 Measure

Progression-free Survival (PFS) per Response Criteria in Solid Tumors (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 3 years ]

Central Contacts

• Genmab Trial Information
  +4570202728
  [email protected]

Locations (50)

Find similar trials in Phoenix, AZ

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