En klinisk studie av anti-cancereffekterna av en utredningsterapi eller kemoterapi hos patienter med återkommande livmodercancer (Fern-EC-01)
9 november 2026 uppdaterad av: BioNTech SE
En fas III, randomiserad, multi-site, öppen studie av BNT323/DB-1303 kontra utredarens val av kemoterapi hos tidigare behandlade patienter med HER2-uttryckande återkommande endometriecancer
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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
480
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: BioNTech clinical trials patient information
- Telefonnummer: +49 6131 9084
- E-post: patients@biontech.de
Studieorter
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Buenos Aires, Argentina, C1280AEB
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- Hospital Británico de Buenos Aires
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Buenos Aires, Argentina, 01426
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- Centro de Oncologia Dr. Doreski - Fundación Respirar
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Buenos Aires, Argentina, B7600FYK
- Rekrytering
- Centro de Investigaciones Medicas Mar del Plata
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Córdoba, Argentina, X5008AAC
- Rekrytering
- CEMAIC - Centro Medico Privado
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La Rioja, Argentina, F5300COE
- Rekrytering
- Investigaciones CORI S.R.L.
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Mendoza, Argentina, M5500AYB
- Rekrytering
- COIR Fundacion Centro Oncologi, de Integracion Regional
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Mendoza, Argentina, M5500
- Rekrytering
- Fundación Oncológica Mendoza
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Rosario, Argentina, S2002KDS
- Rekrytering
- Hospital Provincial del Centenario
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San Juan, Argentina, 5400
- Rekrytering
- Centro Oncológico de Excelencia
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San Miguel de Tucumán, Argentina, 4000
- Rekrytering
- Clinica Mayo de Urgencias
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Adelaide, Australien, 5000
- Rekrytering
- Cancer Research SA
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Adelaide, Australien, 5000
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- Adelaide Oncology & Haematology
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Clayton, Australien, 3168
- Rekrytering
- Monash Health Clinical Trial Center
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Gosford, Australien, 2250
- Rekrytering
- Gosford Hospital
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Melbourne, Australien, 3000
- Rekrytering
- Peter MacCallum Cancer Centre
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Melbourne, Australien, VIC 3199
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- Frankston Hospital
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Nowra, Australien, 2541
- Rekrytering
- Shoalhaven Cancer Care Centre
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Saint Albans, Australien, 3021
- Rekrytering
- Sunshine Hospital
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South Brisbane, Australien, 4001
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- Mater Hospital Brisbane
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Wollongong, Australien, 2500
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- Wollongong Hospital
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Brussels, Belgien, 1070
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- Institut Jules Bordet
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Brussels, Belgien, 1200
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- Cliniques Universitaires Saint-Luc
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Edegem, Belgien, 2650
- Rekrytering
- Universitair Ziekenhuis Antwerpen (UZA)
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Ghent, Belgien, 9000
- Rekrytering
- Universitair Ziekenhuis Gent
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Ghent, Belgien, 9000
- Rekrytering
- AZ Maria Middelares
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Kortrijk, Belgien, 8500
- Rekrytering
- AZ Groeninge VZW
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Leuven, Belgien, 3000
- Rekrytering
- UZ Leuven
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Liège, Belgien, 4000
- Rekrytering
- Centre Hospitalier Universitaire de Liège
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Namur, Belgien, B5000
- Rekrytering
- CHU UCL Namur-Sainte-Elisabeth
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Ipatinga, Brasilien, 35162-189
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- Fundação Sao Francisco Xavier
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Passo Fundo, Brasilien, 99010-260
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- Hospital de Clínicas de Passo Fundo
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Porto Alegre, Brasilien, 90050-170
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- Irmandade da Santa Casa de Misericórdia de Porto Alegre
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Porto Alegre, Brasilien, 90035-000
- Rekrytering
- Instituto de Pesquisa Clínica - Hospital Moinhos de Vento
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Porto Alegre, Brasilien, 90610-000
- Rekrytering
- HPT São Lucas da PUCRS - UBEA
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Porto Alegre, Brasilien, 90035-903
- Rekrytering
- Hospital de Clínicas de Porto Alegre
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São José do Rio Preto, Brasilien, 15090-000
- Rekrytering
- Fundação Faculdade Regional de Medicina de São José do Rio Petro
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São Paulo, Brasilien, 01308-050
- Rekrytering
- Hospital Sirio Libanês
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São Paulo, Brasilien, 01401-002
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- Inst D'Or de Pesquisa E Ensino
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Aalborg, Danmark, 9000
- Rekrytering
- Aalborg Universit Hospital
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Copenhagen, Danmark, 2100
- Rekrytering
- Rigshospitalet
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Herlev, Danmark, 2730
- Rekrytering
- Herlev og Gentofte Hospital
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Odense, Danmark, 5000
- Rekrytering
- Odense University Hospital
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Kuopio, Finland, 70210
- Rekrytering
- Kuopio University HPT
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Oulu, Finland, 90029
- Rekrytering
- OYS Naisten poliklinikka
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Turku, Finland, 20521
- Rekrytering
- Turun yliopistollinen keskussairaala
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Angers, Frankrike, 49055
- Rekrytering
- ICO - Site Paul Papin
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Besançon, Frankrike, 25000
- Rekrytering
- CHU Besançon Service Oncologie
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Caen, Frankrike, 14000
- Rekrytering
- Centre François Baclesse
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Le Mans, Frankrike, 72000
- Rekrytering
- Clinique Victor Hugo - Centre Jean Bernard
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Marseille, Frankrike, 13015
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- Hôpital Nord Bâtiment Mistral
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Paris, Frankrike, 75010
- Rekrytering
- Hôpital Saint Louis
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Saint-Herblain, Frankrike, 44800
- Rekrytering
- ICO - Site René Gauducheau
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Strasbourg, Frankrike, 67000
- Rekrytering
- Institut de Cancérologie de Strasbourg Europe - ICANS
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Vandœuvre-lès-Nancy, Frankrike, 54519
- Rekrytering
- Institut de Cancérologie de Lorraine
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California
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Los Angeles, California, Förenta staterna, 90033
- Rekrytering
- USC/Norris Cancer Center
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
- Rekrytering
- University of Colorado Cancer Center
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Connecticut
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New Haven, Connecticut, Förenta staterna, 06520
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- Yale University School of Medicine
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District of Columbia
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Washington D.C., District of Columbia, Förenta staterna, 20010
- Rekrytering
- MedStar Washington Hospital Center
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Florida
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Fort Lauderdale, Florida, Förenta staterna, 33316
- Rekrytering
- Broward Health Medical Center
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Illinois
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Peoria, Illinois, Förenta staterna, 61637
- Rekrytering
- OSF Saint Francis Medical Center
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Urbana, Illinois, Förenta staterna, 61801
- Rekrytering
- Carle Cancer Institute
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40503
- Rekrytering
- Baptist Health Lexington
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Louisiana
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Shreveport, Louisiana, Förenta staterna, 71103
- Rekrytering
- WK Cancer Center
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55404
- Rekrytering
- Minnesota Oncology
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Nevada
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Reno, Nevada, Förenta staterna, 89511
- Rekrytering
- The Center of Hope Reno
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New York
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Mineola, New York, Förenta staterna, 11501
- Rekrytering
- NYU Langone Hospital - Long Island
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New York, New York, Förenta staterna, 10016
- Rekrytering
- NYU Langone Health
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Syracuse, New York, Förenta staterna, 13210
- Rekrytering
- SUNY Upstate Medical University
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Ohio
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Centerville, Ohio, Förenta staterna, 45459
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- Miami Valley Hospital South
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Hilliard, Ohio, Förenta staterna, 43026
- Rekrytering
- Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73104
- Rekrytering
- Peggy & Charles Stephenson Oklahoma Cancer Center
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Pennsylvania
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Willow Grove, Pennsylvania, Förenta staterna, 19090
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- Asplundh Cancer Pavilion
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South Dakota
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Sioux Falls, South Dakota, Förenta staterna, 57104
- Rekrytering
- Sanford Cancer Center
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Texas
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Tyler, Texas, Förenta staterna, 75702
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- Texas Oncology, P.A.
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Utah
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Murray, Utah, Förenta staterna, 84107-5701
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- Intermountain Healthcare
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Virginia
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Norfolk, Virginia, Förenta staterna, 23502
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- Virginia Oncology Associates
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Athens, Grekland, 11528
- Rekrytering
- Alexandra General Hospital of Athens
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Athens, Grekland, 11528
- Rekrytering
- Aretaieio Hospital
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Chaïdári, Grekland, 124 62
- Rekrytering
- University General Hospital Attikon
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Kalamata, Grekland, 24100
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- General Hospital of Kalamata
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Marousi, Grekland, 151 23
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- IASO General Clinic
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Hadera, Israel, 382302
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- Hillel Yaffe Medical Center
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Haifa, Israel, 3436212
- Rekrytering
- Lady Davis Carmel Medical Center
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Jerusalem, Israel, 9103102
- Rekrytering
- Shaare Zedek Medical Center
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Jerusalem, Israel, 9112001
- Rekrytering
- Hadassah Ein Kerem Medical Center
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Jerusalem, Israel, 9103102
- Rekrytering
- Shaare Zedek
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Petah Tikva, Israel, 4941492
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- Rabin Medical Center-Beilinson Campus
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Ramat Gan, Israel, 5265601
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- Sheba Medical Center
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Tel Aviv, Israel, 642390
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- Sourasky Medical Centre
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Bari, Italien, 70124
- Rekrytering
- Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
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Bologna, Italien, 40138
- Rekrytering
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
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Catania, Italien, 95126
- Rekrytering
- Azienda Ospedaliera Cannizzaro - Oncologia
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Meldola, Italien, 47014
- Rekrytering
- IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST)
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Milan, Italien, 20132
- Rekrytering
- Ospedale San Raffaele
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Milan, Italien, 20133
- Rekrytering
- Istituto Nazionale dei Tumori
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Milan, Italien, 20141
- Rekrytering
- Istituto Europeo di Oncologia
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Milan, Italien, 20159
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- Humanitas San Pio X
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Naples, Italien, 80131
- Rekrytering
- Istituto Nazionale Tumori Fondazione G. Pascale
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Roma, Italien, 00168
- Rekrytering
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Torino, Italien, 10128
- Rekrytering
- Azienda Ospedaliera Ordine Mauriziano Umberto I di Torino
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Montreal, Kanada, H3T 1E2
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- Jewish General Hospital
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St. John's, Kanada, A1V 3V6
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- Health Sciences Centre
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Toronto, Kanada, M5G 2M9
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- Princess Margaret Cancer C
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Wuhan, Kina, 430048
- Rekrytering
- Union Hospital
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Anhui
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Hefei, Anhui, Kina, 230001
- Rekrytering
- Anhui Provincial Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100142
- Rekrytering
- Beijing Cancer Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina, 400010
- Rekrytering
- The Second Affiliated Hospital of Chongqing Medical University
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Fujian
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Fuzhou, Fujian, Kina, 350014
- Rekrytering
- Fujian Provincial Cancer Hospital
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Xiamen, Fujian, Kina, 361003
- Rekrytering
- First Affiliated Hospital of Xiamen University
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Gansu
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Lanzhou, Gansu, Kina, 730050
- Rekrytering
- Gansu Provincial Maternity and Child-care Hospital
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Guangdong
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Guangzhou, Guangdong, Kina, 510080
- Rekrytering
- The First Affiliated Hospital of Sun Yat-sen University
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Shantou, Guangdong, Kina, 515063
- Rekrytering
- Cancer Hospital of Shantou University Medical College
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Guangxi
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Nanning, Guangxi, Kina, 530200
- Rekrytering
- Guangxi Medical University Affiliated Tumor Hospital
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Heilongjiang
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Harbin, Heilongjiang, Kina, 150091
- Rekrytering
- Harbin Medical University Cancer Hospital
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Henan
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Henan, Henan, Kina, 450003
- Rekrytering
- Henan Cancer Hospital
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Zhengzhou, Henan, Kina, 450014
- Rekrytering
- The Second Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan, Hubei, Kina, 430079
- Rekrytering
- Hubei Cancer Hospital
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Xiangyang, Hubei, Kina, 441138
- Rekrytering
- Xiangyang Central Hospital
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Jiangsu
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Nanjing, Jiangsu, Kina, 210008
- Rekrytering
- The Affiliated Hospital of Nanjing University Medical School
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Jiangxi
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Nanchang, Jiangxi, Kina, 330006
- Rekrytering
- Jiangxi Maternal and Child Health Hospital
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Jilin
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Changchun, Jilin, Kina, 130021
- Rekrytering
- The First Hospital of Jilin University
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Shaanxi
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Xi'an, Shaanxi, Kina, 710061
- Rekrytering
- The First Affiliated Hospital of Xian Jiaotong University
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Shandong
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Jinan, Shandong, Kina, 250117
- Rekrytering
- Cancer Hospital of Shandong First Medical University
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Jining, Shandong, Kina, 272029
- Rekrytering
- Affiliated Hospital of Jining Medical University
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Linyi, Shandong, Kina, 276001
- Rekrytering
- Linyi Cancer Hospital
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Yantai, Shandong, Kina, 264000
- Rekrytering
- Yantai Yuhuangding Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200032
- Rekrytering
- Fudan University Shanghai Cancer Center
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Shanghai, Shanghai Municipality, Kina, 200011
- Rekrytering
- Obstetrics & Gynecology Hospital of Fudan University
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Sichuan
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Chengdu, Sichuan, Kina, 610072
- Rekrytering
- Sichuan Provincial People's Hospital
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina, 300060
- Rekrytering
- Tianjin Medical University Cancer Institute & Hospital
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310022
- Rekrytering
- Zhejiang Cancer Hospital
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Wenzhou, Zhejiang, Kina, 325015
- Rekrytering
- The First Affiliated Hospital of Wenzhou Medical University
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Nijmegen, Nederländerna, 6525 GA
- Rekrytering
- Radboud UMC
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Rotterdam, Nederländerna, 3015 AA
- Rekrytering
- Erasmus Medisch Centrum
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Oslo, Norge, 0379
- Rekrytering
- Oslo University Hospital
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Stavanger, Norge, 4011
- Rekrytering
- Stavanger University Hospital
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Bialystok, Polen, 15-027
- Rekrytering
- Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie
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Poznan, Polen, 60-569
- Rekrytering
- Uniwersytecki Szpital Kliniczny w Poznaniu
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Siedlce, Polen, 08-110
- Rekrytering
- Siedleckie Centrum Onkologii
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Singapore, Singapore, 168583
- Rekrytering
- National Cancer Centre Singapore
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Singapore, Singapore, 258499
- Rekrytering
- OncoCare Cancer Centre
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A Coruña, Spanien, 15006
- Rekrytering
- Complejo Hospitalario Universitario A Coruña
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Barcelona, Spanien, 08036
- Rekrytering
- Hospital Clinic de Barcelona
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Barcelona, Spanien, 08035
- Rekrytering
- Hospital Universitari Vall, d'Hebron
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Córdoba, Spanien, 14004
- Rekrytering
- Hospital Universitario Reina Sofia
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Donostia / San Sebastian, Spanien, 20014
- Rekrytering
- Hospital Universitar Donostia
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Girona, Spanien, 17007
- Rekrytering
- Institut Català d'Oncologia (ICO) Hospital Universitari de Girona Dr. Josep Trueta
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Jaén, Spanien, 23007
- Rekrytering
- Hospital Universitario de Jaén
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Madrid, Spanien, 28041
- Rekrytering
- Hospital Universitario 12 de Octubre
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Madrid, Spanien, 28046
- Rekrytering
- Hospital Universitario La Paz
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Madrid, Spanien, 28034
- Rekrytering
- Hospital Universitario Ramón y Cajal
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Palma de Mallorca, Spanien, 07120
- Rekrytering
- Hospital Universit Son Espases
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Valencia, Spanien, 46009
- Rekrytering
- Instituto Valenciano de Oncología - Valencia
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Valencia, Spanien, 46026
- Rekrytering
- Hospital Univers Politec La Fe
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Brighton, Storbritannien, BN2 1ES
- Rekrytering
- Royal Sussex County Hospital
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Bristol, Storbritannien, BS2 8ED
- Rekrytering
- Bristol Haematology and Oncology Centre
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Cambridge, Storbritannien, CB2 0QQ
- Rekrytering
- Addenbrooke's Hospital
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Cottingham, Storbritannien, HU165JQ
- Rekrytering
- Castle Hill Hospital
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Coventry, Storbritannien, CV2 2DX
- Rekrytering
- Warwick Hospital
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Edinburgh, Storbritannien, EH4 2XU
- Rekrytering
- Western General Hospital
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Exeter, Storbritannien, EX2 5DW
- Rekrytering
- Royal Devon & Exeter HPT
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London, Storbritannien, SE1 9RT
- Rekrytering
- Guy's Hospital
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London, Storbritannien, NW1 2PG
- Rekrytering
- University College London Hospitals
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Middlesex, Storbritannien, HA6 2RN
- Rekrytering
- Mount Vermont Cancer Center
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Nottingham, Storbritannien, NG5 1PB
- Rekrytering
- Nottingham University Hospitals NHS Trust
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Swansea, Storbritannien, SA2 8QA
- Rekrytering
- Singleton Hospital
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Truro, Storbritannien, TR1 3LJ
- Rekrytering
- Royal Cornwall Hospital
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Lund, Sverige, 222 42
- Rekrytering
- Skånes Universitetssjukhus Lund
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Stockholm, Sverige, 17176
- Rekrytering
- Karolinska University Hospital
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Uppsala, Sverige, 75185
- Rekrytering
- Akademiska Sjukhuset
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Changwon, Sydkorea, 51353
- Rekrytering
- Samsung Changwon Hospital
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Daegu, Sydkorea, 42601
- Rekrytering
- Keimyung Univty Dongsan Hospital
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Goyang, Sydkorea, 10408
- Rekrytering
- National Cancer Center
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Seongnam, Sydkorea, 13620
- Rekrytering
- Seoul National University Bundang Hospital
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Seongnam-si, Sydkorea, 13496
- Rekrytering
- CHA Bundang Medical Center
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Seoul, Sydkorea, 05505
- Rekrytering
- Asan Medical Center
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Seoul, Sydkorea, 03080
- Rekrytering
- Seoul National University Hospital
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Seoul, Sydkorea, 03722
- Rekrytering
- Severance Hospital, Yonsei University Health System
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Seoul, Sydkorea, 06351
- Rekrytering
- Samsung Medical Center
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Seoul, Sydkorea, 02841
- Rekrytering
- Korea University Anam Hospital
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Seoul, Sydkorea, 06591
- Rekrytering
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Seoul, Sydkorea, 07804
- Rekrytering
- Ewha Womans University Seoul Hospital
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Seoul, Sydkorea, 06273
- Rekrytering
- Gangnam Severance Hospital, Yonsei University Health System
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Taichung, Taiwan, 40705
- Rekrytering
- Taichung Veterans General Hospital
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Taichung, Taiwan, 40447
- Rekrytering
- China Medical University Hospital
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Taichung, Taiwan, 433004
- Rekrytering
- Kuang Tien General Hospital
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Tainan, Taiwan, 70457
- Rekrytering
- National Cheng Kung University Hospital
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Taipei, Taiwan, 11217
- Rekrytering
- Taipei Veterans General Hospital
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Taipei, Taiwan, 10449
- Rekrytering
- MacKay Memorial Hospital_ Taipei Branch
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Brno, Tjeckien, 60200
- Rekrytering
- Gynekologicko-porodnická klinika, Fakultni nemocnice Brno
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Olomouc, Tjeckien, 77900
- Rekrytering
- University Hospital Olomouc - Onkologická klinika- Fakultni
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Ostrava, Tjeckien, 01790
- Rekrytering
- Fakultní nemocnice Ostrava
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Prague, Tjeckien, 12808
- Rekrytering
- Vseobecna fakultni nemocnice v Praze
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Prague, Tjeckien, 15000
- Rekrytering
- Fakultní nemocnice Motol a Homolka
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Prague, Tjeckien, 18081
- Rekrytering
- Fakultní nemocnice Bulovka
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-
-
-
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Adana, Turkiet (Türkiye), 01120
- Rekrytering
- Baskent University Adana Application and Research Center
-
Ankara, Turkiet (Türkiye), 06490
- Rekrytering
- Baskent University Ankara Hospital
-
Ankara, Turkiet (Türkiye), 06200
- Rekrytering
- Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
-
Ankara, Turkiet (Türkiye), 06230
- Rekrytering
- Hacettepe University
-
Bayraklı, Turkiet (Türkiye), 35540
- Rekrytering
- İzmir City Hospital
-
Istanbul, Turkiet (Türkiye), 34093
- Rekrytering
- Istanbul University Istanbul Medical Faculty
-
Istanbul, Turkiet (Türkiye), 34093
- Rekrytering
- Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
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-
-
-
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Berlin, Tyskland, 13353
- Rekrytering
- Charité - Campus Virchow-Klinikum
-
Essen, Tyskland, 45136
- Rekrytering
- Kliniken Essen-Mitte
-
Kassel, Tyskland, 34125
- Rekrytering
- Klinkum Kassel
-
München, Tyskland, 81377
- Rekrytering
- LMU-Campus Innenstadt
-
Tübingen, Tyskland, 72076
- Rekrytering
- Universitaets-Frauenklinik, Tübingen
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-
-
-
-
Budapest, Ungern, 1088
- Rekrytering
- Semmelweis Egyetem
-
Budapest, Ungern, 1122
- Rekrytering
- Országos Onkológiai Intézet
-
Debrecen, Ungern, 4032
- Rekrytering
- Debreceni Egyetem
-
Kecskemét, Ungern, 6000
- Rekrytering
- Bács-Kiskun Vármegyei Oktatókórház
-
Zalaegerszeg, Ungern, 8900
- Rekrytering
- Zala Varmegyei Szent Rafael Korhaz
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-
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Innsbruck, Österrike, 6020
- Rekrytering
- Medizinische Universität Innsbruck
-
Vienna, Österrike, A-1090
- Rekrytering
- Medical University of Vienna
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Kohort 1 (HER2 IHC-poäng 1+ eller 2+): BNT323/DB-1303
|
intravenous (IV) infusion
Andra namn:
|
|
Experimentell: Kohort 2 (HER2 IHC-poäng 3+) - BNT323/DB-1303
|
intravenous (IV) infusion
Andra namn:
|
|
Aktiv komparator: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cohort 1: PFS assessed by blinded independent central review (BICR) in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Kohort 2: Andel deltagare med HER2 IHC 3+ återkommande endometriecancer med förekomst av TEAE:er som leder till avbrott i läkemedelsbehandlingen, dosreduktion eller avslut av studiebehandlingen.
Tidsram: Upp till 35 dagar efter den sista dosen av studibehandlingen
|
Upp till 35 dagar efter den sista dosen av studibehandlingen
|
|
|
Cohort 1: Overall survival (OS) in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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.
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: BioNTech Responsible Person, BioNTech SE
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
10 juni 2025
Primärt slutförande (Beräknad)
1 mars 2028
Avslutad studie (Beräknad)
1 november 2029
Studieregistreringsdatum
Först inskickad
25 mars 2024
Först inskickad som uppfyllde QC-kriterierna
25 mars 2024
Första postat (Faktisk)
1 april 2024
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 november 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 november 2026
Senast verifierad
1 november 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Neoplasmer
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Livmodersjukdomar
- Genitala sjukdomar, kvinnor
- Genitala neoplasmer, hona
- Uterina neoplasmer
- Endometriella neoplasmer
- Organiska kemikalier
- Kolväten
- Cykloparaffiner
- Kolväten, alicyklisk
- Kolväten, cykliska
- Terpener
- Kolhydrater
- Polycykliska aromatiska kolväten
- Kolväten, aromatisk
- Polycykliska föreningar
- Glykosider
- Taxoids
- Cyklodekaner
- Gentare
- Anthracykliner
- Naftakener
- Aminoglykosider
- Daunorubicin
- Docetaxel
- Doxorubicin
- Paklitaxel
Andra studie-ID-nummer
- BNT323-01
- GOG-3105 (Annan identifierare: Gynecologic Oncology Group Foundation)
- ENGOT- EN25/NSGO-CTU (Annan identifierare: European Network for Gynaecological Oncological Trial and Nordic Society of Gynaecological Oncology Clinical Trial Unit)
- 2023 (U.S.S. NIH-anslag/kontrakt)
- 2023-507525-42-00 (Ctis)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .