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

No results posted yet for this study

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07166094 on ClinicalTrials.gov