RecruitingPhase 3NCT07166094

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

A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy


Sponsor

Genmab

Enrollment

544 participants

Start Date

Nov 28, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called Rina-S against other available treatments for women whose endometrial (uterine) cancer has come back or gotten worse after prior therapy. Researchers want to know if Rina-S works better than standard options. **You may be eligible if...** - You have endometrial cancer (uterine cancer) that has returned or progressed after treatment - You have received at least 1 but no more than 3 prior treatments, including both platinum-based chemotherapy and an immunotherapy drug (PD-1/PD-L1 inhibitor) - Your cancer is not a neuroendocrine tumor, carcinosarcoma, or sarcoma **You may NOT be eligible if...** - You have had more than 3 prior lines of cancer treatment - You have never received platinum-based chemotherapy or an immunotherapy drug - You have serious uncontrolled medical conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRina-S

Intravenous (IV) infusion.

DRUGIC

* Paclitaxel: IV infusion * Doxorubicin: IV bolus injection/infusion


Locations(51)

SMH - Sarasota - Main Campus

Sarasota, Florida, United States

Emory Winship Cancer Inst.

Atlanta, Georgia, United States

Emory Winship Cancer Inst.

Atlanta, Georgia, United States

Emory Winship Cancer Inst./Emory Decatur Hospital

Decatur, Georgia, United States

Trials365, LLC

Shreveport, Louisiana, United States

Sinai Hospital

Baltimore, Maryland, United States

William Kahlert Reg. Can. Ctr

Westminster, Maryland, United States

USOR - Minnesota Oncology/ Coon Rapids Clinic

Coon Rapids, Minnesota, United States

USOR - Minnesota Oncology/Edina Clinic

Edina, Minnesota, United States

USOR - Minnesota Oncology/ Maple Grove Clinic

Maple Grove, Minnesota, United States

USOR - Minnesota Oncology/ Maplewood Clinic

Maplewood, Minnesota, United States

USOR - Minnesota Oncology/ Minneapolis Clinic

Minneapolis, Minnesota, United States

USOR - Minnesota Oncology/ Woodbury Clinic

Woodbury, Minnesota, United States

Willamette Valley Cancer Institute and Research Center - Eugene

Eugene, Oregon, United States

NW Cancer Specs. P.C.

Happy Valley, Oregon, United States

USOR - NW Cancer Specs P.C.

Portland, Oregon, United States

USOR - NW Cancer Specs. P.C.

Tigard, Oregon, United States

TX Onc - Arlington North

Arlington, Texas, United States

USOR - Texas Oncology

Austin, Texas, United States

USOR - Texas Oncology

Austin, Texas, United States

USOR - Texas Oncology- Austin North

Austin, Texas, United States

TX Onc - Bedford

Bedford, Texas, United States

TX Onc - Methodist Dallas

Dallas, Texas, United States

TX Onc - Presbyterian Dallas

Dallas, Texas, United States

TX Onc - Methodist Charlton

Dallas, Texas, United States

TX Onc - Sammons

Dallas, Texas, United States

USOR - Texas Oncology - Dallas Fort Worth (DFW)

Fort Worth, Texas, United States

USOR - Texas Oncology

Harlingen, Texas, United States

USOR - Texas Oncology

McAllen, Texas, United States

USOR - TX Oncology - SA NE

San Antonio, Texas, United States

NEXT San Antonio

San Antonio, Texas, United States

USOR - Texas Oncology- Horizon Circle

Waco, Texas, United States

USOR - Texas Oncology- Waco

Waco, Texas, United States

USOR - Texas Oncology

Weslaco, Texas, United States

USOR - NW Cancer Specs P.C.

Vancouver, Washington, United States

Gunma Prefectural Cancer Center

Ōta, Gunma, Japan

Iwate Medical University Hosp

Shiwa-gun, Iwate, Japan

Kitasato University Hospital

Sagamihara-shi, Kanagawa, Japan

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Mie University Hospital

Tsu, Kansai, Japan

NUC Tohoku Univ. Hospital

Sendai, Miyagi, Japan

National Cancer Center Hospital East

Chiba, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Fukushima Medical University Hospital

Fukushima, Japan

Hyogo Cancer Center

Hyōgo, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Saitama Medical University - International Medical Center

Saitama, Japan

Sapporo Medical University Hospital

Sapporo, Japan

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Japan

Cancer Institute Hospital of JFCR

Tokyo, Japan

Yamagata University Hospital

Yamagata, Japan

View Full Details on ClinicalTrials.gov

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NCT07166094


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