A study comparing Rinatabart Sesutecan to other treatments in patients with endometrial cancer who have previously received platinum-based chemotherapy and PD-L1 therapy

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What is this study about?

This study is being conducted to compare the effectiveness and safety of a new drug called rinatabart sesutecan against other treatments chosen by a doctor. The research focuses on individuals with endometrial cancer, which is a type of cancer that starts in the lining of the uterus. This study specifically involves patients whose cancer is advanced, has returned after previous treatment, or has spread to other parts of the body. The participants in this trial have previously received platinum-based chemotherapy and PD(L)-1 therapy, which are types of treatments used to kill cancer cells or help the immune system fight the disease.

In this study, participants will receive either rinatabart sesutecan or a treatment selected by their doctor, which may include medications such as doxorubicin or paclitaxel. These medications are administered through an IV infusion, a method where medicine is delivered directly into a vein through a small tube. The study aims to determine if the new drug works better than the standard options currently available for this condition.

During the course of the study, participants will undergo regular monitoring to track how the cancer responds to the medication and to observe any side effects. The researchers will look at how long the cancer remains stable without growing and the overall survival of the participants. This process involves continuous observation over several years to collect data on how the treatments affect the health and well-being of the individuals involved.

Who Can Join the Study?

  • You must be female.
  • You must have endometrial cancer (cancer of the lining of the uterus) that has returned or is getting worse after previous treatment.
  • The cancer must be a specific type, meaning it cannot be neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma (these are specific, different types of cancer cells).
  • The cancer must have been confirmed through a histology or cytology test (tests where a doctor looks at cells under a microscope to confirm the disease).
  • You must have had between 1 and 3 previous treatments for your cancer.
  • You must have previously received platinum-based chemotherapy (a type of cancer medicine that uses platinum) and a PD(L)-1 inhibitor (a type of immunotherapy, which is a drug that helps your immune system fight cancer).
  • If your cancer returned more than 12 months after your last platinum-based chemotherapy, you must receive more of this treatment unless it is not possible for you to have it.
  • If you are starting immunotherapy (treatment that uses the body’s immune system) for the returning cancer, you do not have to receive more platinum-based chemotherapy.
  • Your cancer must have shown growth or spreading on radiographic imaging (pictures of the inside of your body, such as a CT scan or MRI) since your last treatment.

Who Cannot Join the Study?

  • You have previously received treatment using an antibody-drug conjugate (a type of medicine that uses an antibody to deliver a drug directly to cancer cells) that contains a topoisomerase 1 inhibitor (a substance that stops cancer cells from multiplying).
  • You have a current or past malignancy (cancer) other than the specific type of cancer being studied, or you have signs that a previous cancer is still present in your body. Certain minor cancers that are unlikely to spread or cause death, such as some skin cancers or cancers that were cured more than 3 years ago, may be allowed.
  • You have active cancer that has spread to your central nervous system (the brain and spinal cord) or have carcinomatous meningitis (a condition where cancer cells spread to the membranes covering the brain and spinal cord). People with treated brain cancer may join if they have been stable for 4 weeks and are not taking specific medications for brain symptoms.
  • You have had a gastrointestinal obstruction (a blockage in your stomach or intestines) that required hospital care or caused symptoms within the last 91 days.
  • You show signs of a blockage in your stomach or intestines on medical imaging tests during your screening.
  • You currently require parenteral nutrition (nutrients delivered directly into your veins rather than through eating).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
Universitaet Leipzig Leipzig Germany
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Centr Georges Francois Leclerc Dijon France
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Oslo Universitetssykehus HF Oslo Norway
Hospital Universitario Hm Sanchinarro Madrid Spain
Hospital Universitario De Navarra Pamplona Spain
Centre Jean Perrin Clermont Ferrand France
Comite Entreprise Paul Papin Angers France

Other Sites

Site Name City Country Status
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Virgen del Rocío University Hospital Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
Alexandra Hospital Athens Greece
Hospital Clinic De Barcelona Barcelona Spain
Aalborg University Hospital Aalborg Denmark
Jessa Ziekenhuis Hasselt Belgium
Centre Hospitalier De La Cote Basque Bayonne France
General University Hospital Of Patras Patras Greece
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
HELIOS Klinikum Berlin-Buch GmbH Berlin Germany
Hospital Universitario 12 De Octubre Madrid Spain
Universita Degli Studi Di Brescia Brescia Italy
Servei De Salut De Les Illes Balears Palma Spain
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli Lublin Poland
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Vitaz Sint-Niklaas Belgium
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Hospital Universitario Virgen De La Victoria Malaga Spain
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Diakonie-Klinikum Schwaebisch Hall gGmbH Schwäbisch Hall Germany
Pohjois-Pohjanmaan hyvinvointialue Oulu Finland
Centre Hospitalier Universitaire d’Orléans Orléans France
Hospital Universitario Virgen De Valme Sevilla Spain
Azienda USL Toscana Centro Prato Italy
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Pohjois-Savon hyvinvointialue Kuopio Finland
Pirkanmaan hyvinvointialue Tampere Finland
Hospital Foch Suresnes France
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Grand Hopital De Charleroi Charleroi Belgium
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie Poznan Poland
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble Grenoble France
Immobiliere De Nancy Nancy France
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku Bialystok Poland
Institut Godinot Reims France
Clinique Tivoli Ducos Bordeaux France
Czzroysnv Uybcpculuaizwp Sertiifis Woluwe-Saint-Lambert Belgium
Hdegrftf Vdgt dfecmvyz Barcelona Spain
Hmsnrxgo Uypiguhbcxkly dz A Cgkhhk A Coruna Galicia Spain
Usyacvbsxe Hnoobmdi Cuscein Cologne Germany
Imsojwvt Rmtpdqwab Pwk Lv Srtswb Dis Tsnsds Djvu Arwtmme Ixvs Svnzme Meldola Italy
Hjeyv Brxjdx Hw Bergen Norway
Hzdcdlsh Ueejsgyuui Cskbhwe Hqgxpicx Helsinki Finland
Aastjgh Upalm Spsbunhwz Lhhbrb Dk Bztimrz Bologna Italy
Ukkpcwilwv Of Awhwnbc Edegem Belgium
Ikulkyof Cdnynn Dpezjqffgbfqrqwcz L'hospitalet De Llobregat Spain
Fhvuiscjy Psep Ly Idcxjximgpwtu Bhrovfqnv Drz Hxmoyosy Uukjqapgxeafc Ly Pxg Madrid Spain
Htsfupun Ubkwxrtitgdqsu Strwmtphfg &jwiwnp Hglbfjl dx Hfowompolwj STRASBOURG, Alsace France
Ikglmgpx Rvwjwfcw Dl Crklyo Dl Mxmizlxgqvh Montpellier France
Khdozcmu Llvfe Gzrd Detmold Germany
Vnffsxlmi iqfkfatb Vkghcuet uwygcaushwms lvcsxqadk Sxbehnze kqzbkru fidczkjk Nutcqneguiec vxwpd cmkqvqh Vilnius Lithuania
Usxtaczpmudtv Swfatqy Kgzfoqutw Na 2 Pgo W Scdsvxhqad Szczecin Poland
Avngztp Ofbtguvldgr Pao Lpxfduwpynywpmxbz Cpcsrhfiun Catania Italy
Abvvlyv Uwy Iabcw Di Rxpppp Epyylj Reggio Emilia Italy
Ahbqexm Hkyedoeh Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
27.02.2026
Denmark Denmark
Recruiting
27.02.2026
Finland Finland
Recruiting
27.02.2026
France France
Recruiting
27.02.2026
Germany Germany
Recruiting
27.02.2026
Greece Greece
Recruiting
27.02.2026
Italy Italy
Recruiting
27.02.2026
Lithuania Lithuania
Recruiting
27.02.2026
Norway Norway
Recruiting
27.02.2026
Poland Poland
Recruiting
27.02.2026
Spain Spain
Recruiting
27.02.2026

Trial locations

Rinatabart sesutecan is the experimental treatment being tested in this study to see how well it works against endometrial cancer.

Doxorubicin is a type of chemotherapy drug used as a comparison treatment to help evaluate the effectiveness of the study drug.

Paclitaxel is another chemotherapy drug used as a comparison treatment to help evaluate the effectiveness of the study drug.

Endometrial cancer – This disease occurs when abnormal cells begin to grow in the lining of the uterus. These cells can multiply uncontrollably and form a mass. The condition can start in one specific area or spread to other parts of the uterine lining. It may also progress to involve nearby tissues or move to distant parts of the body. Over time, the abnormal growth can continue to expand and change the structure of the uterine environment.

Trial ID:
2024-519818-31-01
Protocol code:
GCT1184-03
Trial Phase:
Therapeutic confirmatory (Phase III)

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