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

660 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(147)

USAH Mitchell Cancer Inst

Mobile, Alabama, United States

HonorHealth Research Inst

Phoenix, Arizona, United States

Kaiser Permanente SoCal

Irvine, California, United States

Norwalk Hospital

Danbury, Connecticut, United States

Norwalk Hospital

Norwalk, Connecticut, United States

MedStar Washington Hospital

Washington D.C., District of Columbia, United States

SMH - Sarasota - Main Campus

Sarasota, Florida, United States

Women's Care - 9th Ave

St. Petersburg, Florida, United States

Women's Care - Armenia Ave

Tampa, Florida, United States

Emory Winship Cancer Inst.

Atlanta, Georgia, United States

Emory Winship Cancer Inst.

Atlanta, Georgia, United States

Northside Hospital Atlanta

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

UMass Memorial Medical Ctr

Worcester, Massachusetts, United States

Corewell Health

Grand Rapids, Michigan, United States

USOR - Minnesota Oncology-Coon Rapids Clinic

Coon Rapids, Minnesota, 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/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/ Maplewood Clinic

Maplewood, Minnesota, United States

USOR - Minnesota Oncology/ Minneapolis Clinic

Minneapolis, Minnesota, United States

USOR - Minnesota Oncology

Minneapolis, Minnesota, United States

USOR - Minnesota Oncology/ Woodbury Clinic

Woodbury, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Morristown Medical Center

Morristown, New Jersey, United States

Atlantic Health - Overlook MC

Summit, New Jersey, United States

Holy Name Medical Center

Teaneck, New Jersey, United States

NYU Laura and Isaac Perlmutter Cancer Center - 34th Street

New York, New York, United States

Perlmutter CC NYU Langone LI

New York, New York, United States

Duke Cancer Institute

Durham, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, 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

University of Virginia

Charlottesville, Virginia, United States

USOR - NW Cancer Specs P.C.

Vancouver, Washington, United States

GenesisCare Campbelltown

Campbelltown, New South Wales, Australia

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Austin Health

Heidelberg, Australia

Antwerp University Hospital

Edegem, Antwerp, Belgium

Saint-Luc University Clinics

Brussels, Brussels Capital, Belgium

Universitair Ziekenhuis Leuven

Leuven, Flanders, Belgium

Grand Hôpital de Charleroi

Gilly, Hainaut, Belgium

CHU UCL Namur/Ste Elisabeth

Namur, Wallonia, Belgium

VITAZ

Sint-Niklaas, Belgium

Arthur J E Child Cancer Comp

Calgary, Alberta, Canada

BC Cancer - Vancouver

Vancouver, British Columbia, Canada

MUHC - Glen Site

Montreal, Quebec, Canada

Aalborg University Hospital

Aalborg, Denmark

Oulu University Hospital

Oulu, North Ostrobothnia, Finland

Kuopio Univ. Hospital, PSHVA

Kuopio, Northern Savonia, Finland

Hus Ccc/Ctu

Helsinki, Finland

Tampere University Hospital

Tampere, Finland

Centre Jean Perrin

Clermont-Ferrand, Auvergne-Rhône-Alpes, France

GHM Grenoble

Grenoble, Auvergne-Rhône-Alpes, France

HUS Strasbourg

Strasbourg, Bas-Rhin, France

CGFL Dijon

Dijon, Bourgogne-Franche-Comté, France

CHU Brest - Cavale Blanche

Brest, Brittany Region, France

Clinique Tivoli Ducos

Bordeaux, Gironde, France

CHU Orléans - Pharmacie

Orléans, Loiret, France

Cancer Institute Jean Godinot

Reims, Marne, France

L'Hôpital Privé Nancy Lorraine

Nancy, Meurthe-Et-Moselle, France

ICM Montpellier

Montpellier, Occitanie, France

ICO Angers

Angers, Pays de la Loire Region, France

CH de la Côte Basque

Bayonne, Pyrénées-Atlantiques, France

Hôpital Foch

Suresnes, Île-de-France Region, France

Klinikum Lippe GmbH Pharmacy

Lemgo, North Rhine-Westphalia, Germany

Asklepios Hospital Barmbek

Hamburg, Germany

UGH Patras

Pátrai, RIO, Greece

Aretaieio Hospital

Athens, Greece

Alexandra General Hospital

Athens, Greece

Shaare Zedek Medical Center

Jerusalem, Israel

Galilee Medical Center

Nahariya, Israel

Irst Meldola

Meldola, FC, Italy

European Institute of Oncology

Milan, MI, Italy

Humanitas San Pio X

Milan, MI, Italy

Ospedale S Stefano

Prato, PO, Italy

Chiba University Hospital- Center for Outpatient

Chiba, Chiba, Japan

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

Osaka International Cancer Institute - Osaka - Otemae Acti

Osaka, Osaka, Japan

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka, Japan

Keio University Hospital

Tokyo, Tokyo, 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

LSMU Hospital Kauno klinikos

Kaunas, Central Lithuania, Lithuania

Dept., VUH Santaros Clinics

Vilnius, Lithuania

OUH Radium Hospital

Oslo, Oslofjord, Norway

Haukeland University Hospital

Bergen, Vestland, Norway

Siedleckie Centrum Onkologii

Siedlce, Masovian Voivodeship, Poland

Białystok Onc. Ctr. (MSC), GO

Bialystok, Podlaskie Voivodeship, Poland

UCH No. 2, PMU Szczecin

Szczecin, West Pomeranian Voivodeship, Poland

ŚCO SPZOZ Kielce

Kielce, Poland

ICZMP

Lodz, Poland

PR Cancer Specialists

San Juan, Puerto Rico

NUH Singapore

Singapore, Singapore

Curie Oncology (Farrer)

Singapore, Singapore

Hosp. Univ. Son Espases

Palma de Mallorca, Balearic Islands, Spain

Hospital Clínic BCN

Barcelona, Catalonia, Spain

Hospital Universitari de Girona Doctor Josep Trueta

Girona, GI, Spain

CHU A Coruña

A Coruña, La Coruña, Spain

CUN Pamplona

Pamplona, Navarre, Spain

IVO Valencia

Valencia, Valenciana, Comunidad, Spain

CUN Madrid

Madrid, Spain

Hospital La Paz

Madrid, Spain

HM Sanchinarro

Madrid, Spain

HU Virgen de la Victoria

Málaga, Spain

H.R.U. Málaga - Materno-Inf.

Málaga, Spain

HU Virgen del Rocío

Seville, Spain

HU Virgen de Valme

Seville, Spain

HU Miguel Servet

Zaragoza, Spain

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NCT07166094


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