Un estudio clínico de los efectos anticancerígenos de una terapia en investigación o quimioterapia en pacientes con cáncer de útero recurrente (Fern-EC-01)
9 de noviembre de 2026 actualizado por: BioNTech SE
Un ensayo de fase III, aleatorizado, en múltiples sitios y abierto de BNT323 / DB-1303 versus la quimioterapia elegida por el investigador en pacientes previamente tratados con cáncer de endometrio recurrente que expresa HER2
The study is divided into two cohorts (Cohort 1 and Cohort 2), to which participants will be enrolled based on the amount of human epidermal growth factor receptor 2 (HER2) in their tumor sample.
In Cohort 1, the main goal is to assess how well BNT323 (also known as DB-1303) or chemotherapy (doxorubicin or paclitaxel [or docetaxel, if participants cannot take paclitaxel]) works by determining the progression-free survival (PFS) of participants who have been previously treated with immune checkpoint inhibitors (ICIs).
In Cohort 2, the main goal is to assess how well BNT323 works by determining the objective response rate (ORR), that is, the percentage of participants whose tumor shrinks (partial response) or disappears (complete response) after treatment.
The safety of BNT323 will also be assessed by following the occurrence of unfavorable/adverse effects that are seen after treatment. Other measures include the pharmacokinetics of BNT323 (or how BNT323 moves through and out of the body), the body's immune response, and the impact on quality of life.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
This is an open-label, randomized, multi-site, Phase III, interventional clinical study designed to determine the efficacy and safety of BNT323 compared with investigator's choice of single agent chemotherapy in previously treated participants with recurrent endometrial cancer (including HER2 1+ or 2+ score as determined using a centralized immunohistochemistry [IHC] analysis method), whose disease has progressed on at least one line of platinum-based therapy and ICI (Cohort 1). In addition, participants with recurrent endometrial cancer with HER2 IHC 3+ score will be enrolled in a BNT323 monotherapy arm (Cohort 2) to further investigate the efficacy and safety of BNT323.
In Cohort 1, participants will be randomized 2:1 to receive either BNT323/DB-1303 or investigator's choice of single agent chemotherapy, preferably doxorubicin or paclitaxel (or docetaxel if contraindicated to paclitaxel and available at the site) until Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) defined progressive disease (PD) unless there is unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met.
In Cohort 2, participants will receive BNT323 monotherapy until RECIST v1.1 defined PD unless there is unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met.
The study consists of a screening period, a treatment period, a safety follow-up period, an efficacy follow-up period, and a long-term survival follow-up. The expected treatment duration per participant is ~6 months, followed by an anticipated long-term survival follow-up period of up to 53 months.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
480
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: BioNTech clinical trials patient information
- Número de teléfono: +49 6131 9084
- Correo electrónico: patients@biontech.de
Ubicaciones de estudio
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Berlin, Alemania, 13353
- Reclutamiento
- Charité - Campus Virchow-Klinikum
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Essen, Alemania, 45136
- Reclutamiento
- Kliniken Essen-Mitte
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Kassel, Alemania, 34125
- Reclutamiento
- Klinkum Kassel
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München, Alemania, 81377
- Reclutamiento
- LMU-Campus Innenstadt
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Tübingen, Alemania, 72076
- Reclutamiento
- Universitaets-Frauenklinik, Tübingen
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Buenos Aires, Argentina, C1280AEB
- Reclutamiento
- Hospital Británico de Buenos Aires
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Buenos Aires, Argentina, 01426
- Reclutamiento
- Centro de Oncologia Dr. Doreski - Fundación Respirar
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Buenos Aires, Argentina, B7600FYK
- Reclutamiento
- Centro de Investigaciones Medicas Mar del Plata
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Córdoba, Argentina, X5008AAC
- Reclutamiento
- CEMAIC - Centro Medico Privado
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La Rioja, Argentina, F5300COE
- Reclutamiento
- Investigaciones CORI S.R.L.
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Mendoza, Argentina, M5500AYB
- Reclutamiento
- COIR Fundacion Centro Oncologi, de Integracion Regional
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Mendoza, Argentina, M5500
- Reclutamiento
- Fundación Oncológica Mendoza
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Rosario, Argentina, S2002KDS
- Reclutamiento
- Hospital Provincial del Centenario
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San Juan, Argentina, 5400
- Reclutamiento
- Centro Oncológico de Excelencia
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San Miguel de Tucumán, Argentina, 4000
- Reclutamiento
- Clinica Mayo de Urgencias
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Adelaide, Australia, 5000
- Reclutamiento
- Cancer Research SA
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Adelaide, Australia, 5000
- Reclutamiento
- Adelaide Oncology & Haematology
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Clayton, Australia, 3168
- Reclutamiento
- Monash Health Clinical Trial Center
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Gosford, Australia, 2250
- Reclutamiento
- Gosford Hospital
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Melbourne, Australia, 3000
- Reclutamiento
- Peter MacCallum Cancer Centre
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Melbourne, Australia, VIC 3199
- Reclutamiento
- Frankston Hospital
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Nowra, Australia, 2541
- Reclutamiento
- Shoalhaven Cancer Care Centre
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Saint Albans, Australia, 3021
- Reclutamiento
- Sunshine Hospital
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South Brisbane, Australia, 4001
- Reclutamiento
- Mater Hospital Brisbane
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Wollongong, Australia, 2500
- Reclutamiento
- Wollongong Hospital
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Innsbruck, Austria, 6020
- Reclutamiento
- Medizinische Universität Innsbruck
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Vienna, Austria, A-1090
- Reclutamiento
- Medical University of Vienna
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Ipatinga, Brasil, 35162-189
- Reclutamiento
- Fundação Sao Francisco Xavier
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Passo Fundo, Brasil, 99010-260
- Reclutamiento
- Hospital de Clínicas de Passo Fundo
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Porto Alegre, Brasil, 90050-170
- Reclutamiento
- Irmandade da Santa Casa de Misericórdia de Porto Alegre
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Porto Alegre, Brasil, 90035-000
- Reclutamiento
- Instituto de Pesquisa Clínica - Hospital Moinhos de Vento
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Porto Alegre, Brasil, 90610-000
- Reclutamiento
- HPT São Lucas da PUCRS - UBEA
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Porto Alegre, Brasil, 90035-903
- Reclutamiento
- Hospital de Clínicas de Porto Alegre
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São José do Rio Preto, Brasil, 15090-000
- Reclutamiento
- Fundação Faculdade Regional de Medicina de São José do Rio Petro
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São Paulo, Brasil, 01308-050
- Reclutamiento
- Hospital Sirio Libanês
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São Paulo, Brasil, 01401-002
- Reclutamiento
- Inst D'Or de Pesquisa E Ensino
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Brussels, Bélgica, 1070
- Reclutamiento
- Institut Jules Bordet
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Brussels, Bélgica, 1200
- Reclutamiento
- Cliniques Universitaires Saint-Luc
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Edegem, Bélgica, 2650
- Reclutamiento
- Universitair Ziekenhuis Antwerpen (UZA)
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Ghent, Bélgica, 9000
- Reclutamiento
- Universitair Ziekenhuis Gent
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Ghent, Bélgica, 9000
- Reclutamiento
- AZ Maria Middelares
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Kortrijk, Bélgica, 8500
- Reclutamiento
- AZ Groeninge VZW
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Leuven, Bélgica, 3000
- Reclutamiento
- UZ Leuven
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Liège, Bélgica, 4000
- Reclutamiento
- Centre Hospitalier Universitaire de Liège
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Namur, Bélgica, B5000
- Reclutamiento
- CHU UCL Namur-Sainte-Elisabeth
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Montreal, Canadá, H3T 1E2
- Reclutamiento
- Jewish General Hospital
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St. John's, Canadá, A1V 3V6
- Reclutamiento
- Health Sciences Centre
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Toronto, Canadá, M5G 2M9
- Reclutamiento
- Princess Margaret Cancer C
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Brno, Chequia, 60200
- Reclutamiento
- Gynekologicko-porodnická klinika, Fakultni nemocnice Brno
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Olomouc, Chequia, 77900
- Reclutamiento
- University Hospital Olomouc - Onkologická klinika- Fakultni
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Ostrava, Chequia, 01790
- Reclutamiento
- Fakultní nemocnice Ostrava
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Prague, Chequia, 12808
- Reclutamiento
- Vseobecna fakultni nemocnice v Praze
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Prague, Chequia, 15000
- Reclutamiento
- Fakultní nemocnice Motol a Homolka
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Prague, Chequia, 18081
- Reclutamiento
- Fakultní nemocnice Bulovka
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Changwon, Corea del Sur, 51353
- Reclutamiento
- Samsung Changwon Hospital
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Daegu, Corea del Sur, 42601
- Reclutamiento
- Keimyung Univty Dongsan Hospital
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Goyang, Corea del Sur, 10408
- Reclutamiento
- National Cancer Center
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Seongnam, Corea del Sur, 13620
- Reclutamiento
- Seoul National University Bundang Hospital
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Seongnam-si, Corea del Sur, 13496
- Reclutamiento
- CHA Bundang Medical Center
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Seoul, Corea del Sur, 05505
- Reclutamiento
- Asan Medical Center
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Seoul, Corea del Sur, 03080
- Reclutamiento
- Seoul National University Hospital
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Seoul, Corea del Sur, 03722
- Reclutamiento
- Severance Hospital, Yonsei University Health System
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Seoul, Corea del Sur, 06351
- Reclutamiento
- Samsung Medical Center
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Seoul, Corea del Sur, 02841
- Reclutamiento
- Korea University Anam Hospital
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Seoul, Corea del Sur, 06591
- Reclutamiento
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Seoul, Corea del Sur, 07804
- Reclutamiento
- Ewha Womans University Seoul Hospital
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Seoul, Corea del Sur, 06273
- Reclutamiento
- Gangnam Severance Hospital, Yonsei University Health System
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Aalborg, Dinamarca, 9000
- Reclutamiento
- Aalborg Universit Hospital
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Copenhagen, Dinamarca, 2100
- Reclutamiento
- Rigshospitalet
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Herlev, Dinamarca, 2730
- Reclutamiento
- Herlev og Gentofte Hospital
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Odense, Dinamarca, 5000
- Reclutamiento
- Odense University Hospital
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A Coruña, España, 15006
- Reclutamiento
- Complejo Hospitalario Universitario A Coruña
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Barcelona, España, 08036
- Reclutamiento
- Hospital Clinic de Barcelona
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Barcelona, España, 08035
- Reclutamiento
- Hospital Universitari Vall, d'Hebron
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Córdoba, España, 14004
- Reclutamiento
- Hospital Universitario Reina Sofia
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Donostia / San Sebastian, España, 20014
- Reclutamiento
- Hospital Universitar Donostia
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Girona, España, 17007
- Reclutamiento
- Institut Català d'Oncologia (ICO) Hospital Universitari de Girona Dr. Josep Trueta
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Jaén, España, 23007
- Reclutamiento
- Hospital Universitario de Jaén
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Madrid, España, 28041
- Reclutamiento
- Hospital Universitario 12 de Octubre
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Madrid, España, 28046
- Reclutamiento
- Hospital Universitario La Paz
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Madrid, España, 28034
- Reclutamiento
- Hospital Universitario Ramón y Cajal
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Palma de Mallorca, España, 07120
- Reclutamiento
- Hospital Universit Son Espases
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Valencia, España, 46009
- Reclutamiento
- Instituto Valenciano de Oncología - Valencia
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Valencia, España, 46026
- Reclutamiento
- Hospital Univers Politec La Fe
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California
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Los Angeles, California, Estados Unidos, 90033
- Reclutamiento
- USC/Norris Cancer Center
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Reclutamiento
- University of Colorado Cancer Center
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06520
- Reclutamiento
- Yale University School of Medicine
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20010
- Reclutamiento
- MedStar Washington Hospital Center
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Florida
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Fort Lauderdale, Florida, Estados Unidos, 33316
- Reclutamiento
- Broward Health Medical Center
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Illinois
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Peoria, Illinois, Estados Unidos, 61637
- Reclutamiento
- OSF Saint Francis Medical Center
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Urbana, Illinois, Estados Unidos, 61801
- Reclutamiento
- Carle Cancer Institute
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40503
- Reclutamiento
- Baptist Health Lexington
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Louisiana
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Shreveport, Louisiana, Estados Unidos, 71103
- Reclutamiento
- WK Cancer Center
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55404
- Reclutamiento
- Minnesota Oncology
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Nevada
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Reno, Nevada, Estados Unidos, 89511
- Reclutamiento
- The Center of Hope Reno
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New York
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Mineola, New York, Estados Unidos, 11501
- Reclutamiento
- NYU Langone Hospital - Long Island
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New York, New York, Estados Unidos, 10016
- Reclutamiento
- NYU Langone Health
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Syracuse, New York, Estados Unidos, 13210
- Reclutamiento
- SUNY Upstate Medical University
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Ohio
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Centerville, Ohio, Estados Unidos, 45459
- Reclutamiento
- Miami Valley Hospital South
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Hilliard, Ohio, Estados Unidos, 43026
- Reclutamiento
- Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- Reclutamiento
- Peggy & Charles Stephenson Oklahoma Cancer Center
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Pennsylvania
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Willow Grove, Pennsylvania, Estados Unidos, 19090
- Reclutamiento
- Asplundh Cancer Pavilion
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos, 57104
- Reclutamiento
- Sanford Cancer Center
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Texas
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Tyler, Texas, Estados Unidos, 75702
- Reclutamiento
- Texas Oncology, P.A.
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Utah
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Murray, Utah, Estados Unidos, 84107-5701
- Reclutamiento
- Intermountain Healthcare
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Virginia
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Norfolk, Virginia, Estados Unidos, 23502
- Reclutamiento
- Virginia Oncology Associates
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Kuopio, Finlandia, 70210
- Reclutamiento
- Kuopio University HPT
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Oulu, Finlandia, 90029
- Reclutamiento
- OYS Naisten poliklinikka
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Turku, Finlandia, 20521
- Reclutamiento
- Turun yliopistollinen keskussairaala
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Angers, Francia, 49055
- Reclutamiento
- ICO - Site Paul Papin
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Besançon, Francia, 25000
- Reclutamiento
- CHU Besançon Service Oncologie
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Caen, Francia, 14000
- Reclutamiento
- Centre François Baclesse
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Le Mans, Francia, 72000
- Reclutamiento
- Clinique Victor Hugo - Centre Jean Bernard
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Marseille, Francia, 13015
- Reclutamiento
- Hôpital Nord Bâtiment Mistral
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Paris, Francia, 75010
- Reclutamiento
- Hôpital Saint Louis
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Saint-Herblain, Francia, 44800
- Reclutamiento
- ICO - Site René Gauducheau
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Strasbourg, Francia, 67000
- Reclutamiento
- Institut de Cancérologie de Strasbourg Europe - ICANS
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Vandœuvre-lès-Nancy, Francia, 54519
- Reclutamiento
- Institut de Cancérologie de Lorraine
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Athens, Grecia, 11528
- Reclutamiento
- Alexandra General Hospital of Athens
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Athens, Grecia, 11528
- Reclutamiento
- Aretaieio Hospital
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Chaïdári, Grecia, 124 62
- Reclutamiento
- University General Hospital Attikon
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Kalamata, Grecia, 24100
- Reclutamiento
- General Hospital of Kalamata
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Marousi, Grecia, 151 23
- Reclutamiento
- IASO General Clinic
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Budapest, Hungría, 1088
- Reclutamiento
- Semmelweis Egyetem
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Budapest, Hungría, 1122
- Reclutamiento
- Országos Onkológiai Intézet
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Debrecen, Hungría, 4032
- Reclutamiento
- Debreceni Egyetem
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Kecskemét, Hungría, 6000
- Reclutamiento
- Bács-Kiskun Vármegyei Oktatókórház
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Zalaegerszeg, Hungría, 8900
- Reclutamiento
- Zala Varmegyei Szent Rafael Korhaz
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Hadera, Israel, 382302
- Reclutamiento
- Hillel Yaffe Medical Center
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Haifa, Israel, 3436212
- Reclutamiento
- Lady Davis Carmel Medical Center
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Jerusalem, Israel, 9103102
- Reclutamiento
- Shaare Zedek Medical Center
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Jerusalem, Israel, 9112001
- Reclutamiento
- Hadassah Ein Kerem Medical Center
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Jerusalem, Israel, 9103102
- Reclutamiento
- Shaare Zedek
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Petah Tikva, Israel, 4941492
- Reclutamiento
- Rabin Medical Center-Beilinson Campus
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Ramat Gan, Israel, 5265601
- Reclutamiento
- Sheba Medical Center
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Tel Aviv, Israel, 642390
- Reclutamiento
- Sourasky Medical Centre
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Bari, Italia, 70124
- Reclutamiento
- Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
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Bologna, Italia, 40138
- Reclutamiento
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
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Catania, Italia, 95126
- Reclutamiento
- Azienda Ospedaliera Cannizzaro - Oncologia
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Meldola, Italia, 47014
- Reclutamiento
- IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST)
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Milan, Italia, 20132
- Reclutamiento
- Ospedale San Raffaele
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Milan, Italia, 20133
- Reclutamiento
- Istituto Nazionale dei Tumori
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Milan, Italia, 20141
- Reclutamiento
- Istituto Europeo di Oncologia
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Milan, Italia, 20159
- Reclutamiento
- Humanitas San Pio X
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Naples, Italia, 80131
- Reclutamiento
- Istituto Nazionale Tumori Fondazione G. Pascale
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Roma, Italia, 00168
- Reclutamiento
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Torino, Italia, 10128
- Reclutamiento
- Azienda Ospedaliera Ordine Mauriziano Umberto I di Torino
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Oslo, Noruega, 0379
- Reclutamiento
- Oslo University Hospital
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Stavanger, Noruega, 4011
- Reclutamiento
- Stavanger University Hospital
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Nijmegen, Países Bajos, 6525 GA
- Reclutamiento
- Radboud UMC
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Rotterdam, Países Bajos, 3015 AA
- Reclutamiento
- Erasmus Medisch Centrum
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Bialystok, Polonia, 15-027
- Reclutamiento
- Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie
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Poznan, Polonia, 60-569
- Reclutamiento
- Uniwersytecki Szpital Kliniczny w Poznaniu
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Siedlce, Polonia, 08-110
- Reclutamiento
- Siedleckie Centrum Onkologii
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Wuhan, Porcelana, 430048
- Reclutamiento
- Union Hospital
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Anhui
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Hefei, Anhui, Porcelana, 230001
- Reclutamiento
- Anhui Provincial Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100142
- Reclutamiento
- Beijing Cancer Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Porcelana, 400010
- Reclutamiento
- The Second Affiliated Hospital of Chongqing Medical University
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Fujian
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Fuzhou, Fujian, Porcelana, 350014
- Reclutamiento
- Fujian Provincial Cancer Hospital
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Xiamen, Fujian, Porcelana, 361003
- Reclutamiento
- First Affiliated Hospital of Xiamen University
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Gansu
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Lanzhou, Gansu, Porcelana, 730050
- Reclutamiento
- Gansu Provincial Maternity and Child-care Hospital
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510080
- Reclutamiento
- The First Affiliated Hospital of Sun Yat-sen University
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Shantou, Guangdong, Porcelana, 515063
- Reclutamiento
- Cancer Hospital of Shantou University Medical College
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Guangxi
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Nanning, Guangxi, Porcelana, 530200
- Reclutamiento
- Guangxi Medical University Affiliated Tumor Hospital
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Heilongjiang
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Harbin, Heilongjiang, Porcelana, 150091
- Reclutamiento
- Harbin Medical University Cancer Hospital
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Henan
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Henan, Henan, Porcelana, 450003
- Reclutamiento
- Henan Cancer Hospital
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Zhengzhou, Henan, Porcelana, 450014
- Reclutamiento
- The Second Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan, Hubei, Porcelana, 430079
- Reclutamiento
- Hubei Cancer Hospital
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Xiangyang, Hubei, Porcelana, 441138
- Reclutamiento
- Xiangyang Central Hospital
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Jiangsu
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Nanjing, Jiangsu, Porcelana, 210008
- Reclutamiento
- The Affiliated Hospital of Nanjing University Medical School
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Jiangxi
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Nanchang, Jiangxi, Porcelana, 330006
- Reclutamiento
- Jiangxi Maternal and Child Health Hospital
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Jilin
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Changchun, Jilin, Porcelana, 130021
- Reclutamiento
- The First Hospital of Jilin University
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Shaanxi
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Xi'an, Shaanxi, Porcelana, 710061
- Reclutamiento
- The First Affiliated Hospital of Xian Jiaotong University
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Shandong
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Jinan, Shandong, Porcelana, 250117
- Reclutamiento
- Cancer Hospital of Shandong First Medical University
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Jining, Shandong, Porcelana, 272029
- Reclutamiento
- Affiliated Hospital of Jining Medical University
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Linyi, Shandong, Porcelana, 276001
- Reclutamiento
- Linyi Cancer Hospital
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Yantai, Shandong, Porcelana, 264000
- Reclutamiento
- Yantai Yuhuangding Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200032
- Reclutamiento
- Fudan University Shanghai Cancer Center
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Shanghai, Shanghai Municipality, Porcelana, 200011
- Reclutamiento
- Obstetrics & Gynecology Hospital of Fudan University
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Sichuan
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Chengdu, Sichuan, Porcelana, 610072
- Reclutamiento
- Sichuan Provincial People's Hospital
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Porcelana, 300060
- Reclutamiento
- Tianjin Medical University Cancer Institute & Hospital
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310022
- Reclutamiento
- Zhejiang Cancer Hospital
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Wenzhou, Zhejiang, Porcelana, 325015
- Reclutamiento
- The First Affiliated Hospital of Wenzhou Medical University
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Brighton, Reino Unido, BN2 1ES
- Reclutamiento
- Royal Sussex County Hospital
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Bristol, Reino Unido, BS2 8ED
- Reclutamiento
- Bristol Haematology and Oncology Centre
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Cambridge, Reino Unido, CB2 0QQ
- Reclutamiento
- Addenbrooke's Hospital
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Cottingham, Reino Unido, HU165JQ
- Reclutamiento
- Castle Hill Hospital
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Coventry, Reino Unido, CV2 2DX
- Reclutamiento
- Warwick Hospital
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Edinburgh, Reino Unido, EH4 2XU
- Reclutamiento
- Western General Hospital
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Exeter, Reino Unido, EX2 5DW
- Reclutamiento
- Royal Devon & Exeter HPT
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London, Reino Unido, SE1 9RT
- Reclutamiento
- Guy's Hospital
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London, Reino Unido, NW1 2PG
- Reclutamiento
- University College London Hospitals
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Middlesex, Reino Unido, HA6 2RN
- Reclutamiento
- Mount Vermont Cancer Center
-
Nottingham, Reino Unido, NG5 1PB
- Reclutamiento
- Nottingham University Hospitals NHS Trust
-
Swansea, Reino Unido, SA2 8QA
- Reclutamiento
- Singleton Hospital
-
Truro, Reino Unido, TR1 3LJ
- Reclutamiento
- Royal Cornwall Hospital
-
-
-
-
-
Singapore, Singapur, 168583
- Reclutamiento
- National Cancer Centre Singapore
-
Singapore, Singapur, 258499
- Reclutamiento
- OncoCare Cancer Centre
-
-
-
-
-
Lund, Suecia, 222 42
- Reclutamiento
- Skånes Universitetssjukhus Lund
-
Stockholm, Suecia, 17176
- Reclutamiento
- Karolinska University Hospital
-
Uppsala, Suecia, 75185
- Reclutamiento
- Akademiska Sjukhuset
-
-
-
-
-
Taichung, Taiwán, 40705
- Reclutamiento
- Taichung Veterans General Hospital
-
Taichung, Taiwán, 40447
- Reclutamiento
- China Medical University Hospital
-
Taichung, Taiwán, 433004
- Reclutamiento
- Kuang Tien General Hospital
-
Tainan, Taiwán, 70457
- Reclutamiento
- National Cheng Kung University Hospital
-
Taipei, Taiwán, 11217
- Reclutamiento
- Taipei Veterans General Hospital
-
Taipei, Taiwán, 10449
- Reclutamiento
- MacKay Memorial Hospital_ Taipei Branch
-
-
-
-
-
Adana, Turquía (Türkiye), 01120
- Reclutamiento
- Baskent University Adana Application and Research Center
-
Ankara, Turquía (Türkiye), 06490
- Reclutamiento
- Baskent University Ankara Hospital
-
Ankara, Turquía (Türkiye), 06200
- Reclutamiento
- Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
-
Ankara, Turquía (Türkiye), 06230
- Reclutamiento
- Hacettepe University
-
Bayraklı, Turquía (Türkiye), 35540
- Reclutamiento
- İzmir City Hospital
-
Istanbul, Turquía (Türkiye), 34093
- Reclutamiento
- Istanbul University Istanbul Medical Faculty
-
Istanbul, Turquía (Türkiye), 34093
- Reclutamiento
- Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Key Inclusion Criteria:
-
Are female adults (defined as ≥18 years of age or acceptable age according to local regulations at the time of voluntarily giving informed consent).
-
Have histologically confirmed endometrial cancer that:
- Is recurrent,
- Has a HER2 IHC score of 1+, 2+ (Cohort 1), or 3+ (Cohort 2) as determined by central laboratory testing for HER2 expression, and
- Is not defined as a true sarcoma (i.e., leiomyosarcoma or endometrial stromal sarcoma). Note: Uterine carcinosarcoma is allowed.
-
Have measurable disease defined by RECIST v1.1.
-
Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
-
Have recurrent endometrial cancer and meet any of the following:
- developed recurrence <12 months from completing platinum-based chemotherapy given as adjuvant therapy for Stage I to III disease, or
- developed recurrence after platinum-based chemotherapy in the recurrent/metastatic setting.
-
Have received prior ICI treatment (i.e., anti-programmed death 1/anti-programmed death-ligand 1)
-
Have a life expectancy of ≥12 weeks at screening.
Key Exclusion Criteria:
- Are ineligible for all options in the investigator's choice of chemotherapy arm, per local prescribing information and institutional guidelines (applicable to Cohort 1 only).
- Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior the first dose of study treatment.
- Have an uncontrolled intercurrent illness that would limit compliance with study requirement or substantially increase risk of incurring adverse events.
- Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, or peritoneal shunt within 2 weeks prior to the first dose of study treatment.
- Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- Participants with prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment, except for intranasal and inhaled corticosteroids or systemic corticosteroids at doses of less than 10 mg/day of prednisone or equivalent, and topical corticosteroids. Participants receiving corticosteroids may continue if the dose is stable upon giving main informed consent.
- Have a lung-specific intercurrent clinically significant illness including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months prior to the first dose of study treatment, severe asthma, chronic obstructive pulmonary disorder with moderate acute exacerbations, restrictive lung disease, pulmonary fibrosis, radiation pneumonitis, significant pleural effusion etc.), or any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (i.e., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis etc.), and/or prior pneumonectomy (complete).
- Have uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to the first dose of study treatment.
- Have unresolved toxicities from previous anti-cancer therapy, defined as toxicities (other than alopecia, fatigue, or endocrinopathies that are well controlled) not yet resolved to Grade ≤1 or baseline.
- Are pregnant or breastfeeding or are planning pregnancy during the study or within 7 months after the last dose of study treatment.
- Have a history of allergies, hypersensitivities, or intolerance to study treatments (investigational medicinal products and auxiliary medicinal product) including any excipients thereof or to other monoclonal antibodies. Participants who have successfully undergone a desensitization process and are able to tolerate the drug are eligible.
- Had prior treatment with topoisomerase I inhibitors, including ADCs.
- Have left ventricular ejection fraction <55% by either echocardiography or multiple-gated acquisition within 28 days prior to the first dose of study treatment. This includes participants with tissue doppler E/e' ratio >15.
NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Cohorte 1 (puntuación IHC HER2 1+ o 2+): BNT323/DB-1303
|
intravenous (IV) infusion
Otros nombres:
|
|
Experimental: Cohorte 2 (puntuación IHC de HER2 3+) - BNT323/DB-1303
|
intravenous (IV) infusion
Otros nombres:
|
|
Comparador activo: Cohort 1 - Doxorubicin or paclitaxel (or docetaxel)
Single agent chemotherapy (either doxorubicin or paclitaxel) per investigator's choice. Participants with contraindications to paclitaxel may receive docetaxel as an alternative (if available at the site). |
IV infusion IV infusion IV bolus or infusion |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cohort 1: PFS assessed by blinded independent central review (BICR) in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
Periodo de tiempo: Up to approximately 53 months
|
By treatment arm. Defined as the time from randomization to the first objective tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first. |
Up to approximately 53 months
|
|
Cohort 2: ORR assessed by BICR in participants with HER2 IHC 3+ recurrent endometrial cancer
Periodo de tiempo: Up to approximately 53 months
|
Defined as the proportion of participants with a CR or PR (per RECIST v1.1) as best overall response with confirmation. |
Up to approximately 53 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cohorte 2: Porcentaje de participantes con cáncer de endometrio recurrente HER2 IHC 3+ con aparición de TEAEs que condujeron a la interrupción del fármaco, reducción de la dosis o interrupción del tratamiento del estudio.
Periodo de tiempo: Hasta 35 días después de la última dosis del tratamiento en estudio
|
Hasta 35 días después de la última dosis del tratamiento en estudio
|
|
|
Cohort 1: Overall survival (OS) in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
Periodo de tiempo: Up to approximately 53 months
|
By treatment arm. Defined as the time from randomization to death from any cause. |
Up to approximately 53 months
|
|
Cohort 1: PFS assessed by the investigator in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
Periodo de tiempo: Up to approximately 53 months
|
By treatment arm. Defined as the time from randomization to the first objective tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first. |
Up to approximately 53 months
|
|
Cohort 1: ORR assessed by BICR in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
Periodo de tiempo: Up to approximately 53 months
|
By treatment arm. Defined as the proportion of participants with a CR or PR (per RECIST v1.1) as best overall response with confirmation. |
Up to approximately 53 months
|
|
Cohort 1: ORR assessed by the investigator in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
Periodo de tiempo: Up to approximately 53 months
|
By treatment arm. Defined as the proportion of participants with a CR or PR (per RECIST v1.1) as best overall response with confirmation. |
Up to approximately 53 months
|
|
Cohort 1: Duration of response (DoR) assessed by BICR in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
Periodo de tiempo: Up to approximately 53 months
|
By treatment arm. Defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (PD per RECIST v1.1) or death from any cause, whichever occurs first. |
Up to approximately 53 months
|
|
Cohort 1: DoR assessed by the investigator in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
Periodo de tiempo: Up to approximately 53 months
|
By treatment arm. Defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (PD per RECIST v1.1) or death from any cause, whichever occurs first. |
Up to approximately 53 months
|
|
Cohort 1: Percentage of participants with HER2 IHC 1+/2+ recurrent endometrial cancer with occurrence of treatment-emergent adverse events (TEAEs)
Periodo de tiempo: Up to 35 days after the last dose of study treatment
|
By treatment arm. TEAEs including Grade ≥3, serious, and fatal TEAEs by relationship. |
Up to 35 days after the last dose of study treatment
|
|
Cohort 1: Percentage of participants with HER2 IHC 1+/2+ recurrent endometrial cancer with occurrence of TEAEs leading to drug interruption, dose reduction, or discontinuation of study treatment.
Periodo de tiempo: Up to 35 days after the last dose of study treatment
|
By treatment arm. |
Up to 35 days after the last dose of study treatment
|
|
Cohort 2: ORR assessed by the investigator participants with HER2 IHC 3+ recurrent endometrial cancer
Periodo de tiempo: Up to approximately 53 months
|
Defined as the proportion of participants in whom a CR or PR (per RECIST v1.1) is observed as best overall response with confirmation. |
Up to approximately 53 months
|
|
Cohort 2: DoR assessed by BICR in participants with HER2 IHC 3+ recurrent endometrial cancer
Periodo de tiempo: Up to approximately 53 months
|
Defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (PD per RECIST v1.1) or death from any cause, whichever occurs first. |
Up to approximately 53 months
|
|
Cohort 2: DoR assessed by the investigator in participants with HER2 IHC 3+ recurrent endometrial cancer
Periodo de tiempo: Up to approximately 53 months
|
Defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (PD per RECIST v1.1) or death from any cause, whichever occurs first. |
Up to approximately 53 months
|
|
Cohort 2: PFS assessed by BICR in participants with HER2 IHC 3+ recurrent endometrial cancer
Periodo de tiempo: Up to approximately 53 months
|
Defined as the time from the first dose of study treatment to the first objective tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first. |
Up to approximately 53 months
|
|
Cohort 2: PFS assessed by the investigator in participants with HER2 IHC 3+ recurrent endometrial cancer
Periodo de tiempo: Up to approximately 53 months
|
Defined as the time from the first dose of study treatment to the first objective tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first. |
Up to approximately 53 months
|
|
Cohort 2: OS in participants with HER2 IHC 3+ recurrent endometrial cancer
Periodo de tiempo: Up to approximately 53 months
|
Defined as the time from the first dose of trial treatment to death from any cause. |
Up to approximately 53 months
|
|
Cohort 2: Percentage of participants with HER2 IHC 3+ recurrent endometrial cancer with occurrence of TEAEs
Periodo de tiempo: Up to 35 days after the last dose of study treatment
|
BNT323 monotherapy. TEAEs including Grade ≥3, serious, and fatal TEAEs by relationship. |
Up to 35 days after the last dose of study treatment
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: BioNTech Responsible Person, BioNTech SE
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
10 de junio de 2025
Finalización primaria (Estimado)
1 de marzo de 2028
Finalización del estudio (Estimado)
1 de noviembre de 2029
Fechas de registro del estudio
Enviado por primera vez
25 de marzo de 2024
Primero enviado que cumplió con los criterios de control de calidad
25 de marzo de 2024
Publicado por primera vez (Actual)
1 de abril de 2024
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de noviembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de noviembre de 2026
Última verificación
1 de noviembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
- Inhibidor del punto de control inmunitario
- Conjugado de anticuerpo y fármaco (ADC)
- Terapia a base de platino
- Receptor 2 del factor de crecimiento epidérmico humano (HER2)
- Tumores que expresan HER2
- Cáncer de endometrio recurrente
- Puntuaciones IHC 1+, 2+ y 3+
- Expresión de la proteína HER2
- Cáncer de endometrio que expresa HER2
- Receptor ErbB-2
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades uterinas
- Enfermedades Genitales Femeninas
- Neoplasias Genitales Femeninas
- Neoplasias Uterinas
- Neoplasias Endometriales
- Químicos orgánicos
- Hidrocarburos
- Cicloparafinas
- Hidrocarburos, alicíclicos
- Hidrocarburos, cíclico
- Terpenos
- Carbohidratos
- Hidrocarburos aromáticos policíclicos
- Hidrocarburos, aromáticos
- Compuestos policíclicos
- Glucósidos
- Taxaides
- Ciclodecanos
- Diterpenos
- Antraciclinas
- Naftacenos
- Aminoglucósidos
- Daunorrubicina
- Docetaxel
- Doxorrubicina
- Paclitaxel
Otros números de identificación del estudio
- BNT323-01
- GOG-3105 (Otro identificador: Gynecologic Oncology Group Foundation)
- ENGOT- EN25/NSGO-CTU (Otro identificador: European Network for Gynaecological Oncological Trial and Nordic Society of Gynaecological Oncology Clinical Trial Unit)
- 2023 (Subvención/contrato del NIH de EE. UU.)
- 2023-507525-42-00 (Ctis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .