Een klinische studie naar de antikankereffecten van onderzoekstherapie of chemotherapie bij patiënten met terugkerende baarmoederkanker (Fern-EC-01)
9 november 2026 bijgewerkt door: BioNTech SE
Een fase III, gerandomiseerde, multi-site, open-label studie van BNT323/DB-1303 versus de keuze van de onderzoeker voor chemotherapie bij eerder behandelde patiënten met recidiverende endometriumkanker met HER2-expressie
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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
480
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: BioNTech clinical trials patient information
- Telefoonnummer: +49 6131 9084
- E-mail: patients@biontech.de
Studie Locaties
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Buenos Aires, Argentinië, C1280AEB
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- Hospital Británico de Buenos Aires
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Buenos Aires, Argentinië, 01426
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- Centro de Oncologia Dr. Doreski - Fundación Respirar
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Buenos Aires, Argentinië, B7600FYK
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- Centro de Investigaciones Medicas Mar del Plata
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Córdoba, Argentinië, X5008AAC
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- CEMAIC - Centro Medico Privado
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La Rioja, Argentinië, F5300COE
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- Investigaciones CORI S.R.L.
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Mendoza, Argentinië, M5500AYB
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- COIR Fundacion Centro Oncologi, de Integracion Regional
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Mendoza, Argentinië, M5500
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- Fundación Oncológica Mendoza
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Rosario, Argentinië, S2002KDS
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- Hospital Provincial del Centenario
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San Juan, Argentinië, 5400
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- Centro Oncológico de Excelencia
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San Miguel de Tucumán, Argentinië, 4000
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- Clinica Mayo de Urgencias
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Adelaide, Australië, 5000
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- Cancer Research SA
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Adelaide, Australië, 5000
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- Adelaide Oncology & Haematology
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Clayton, Australië, 3168
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- Monash Health Clinical Trial Center
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Gosford, Australië, 2250
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- Gosford Hospital
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Melbourne, Australië, 3000
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- Peter MacCallum Cancer Centre
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Melbourne, Australië, VIC 3199
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- Frankston Hospital
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Nowra, Australië, 2541
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- Shoalhaven Cancer Care Centre
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Saint Albans, Australië, 3021
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- Sunshine Hospital
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South Brisbane, Australië, 4001
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- Mater Hospital Brisbane
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Wollongong, Australië, 2500
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- Wollongong Hospital
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Brussels, België, 1070
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- Institut Jules Bordet
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Brussels, België, 1200
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- Cliniques Universitaires Saint-Luc
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Edegem, België, 2650
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- Universitair Ziekenhuis Antwerpen (UZA)
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Ghent, België, 9000
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- Universitair Ziekenhuis Gent
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Ghent, België, 9000
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- AZ Maria Middelares
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Kortrijk, België, 8500
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- AZ Groeninge VZW
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Leuven, België, 3000
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- UZ Leuven
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Liège, België, 4000
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- Centre Hospitalier Universitaire de Liège
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Namur, België, B5000
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- CHU UCL Namur-Sainte-Elisabeth
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Ipatinga, Brazilië, 35162-189
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- Fundação Sao Francisco Xavier
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Passo Fundo, Brazilië, 99010-260
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- Hospital de Clínicas de Passo Fundo
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Porto Alegre, Brazilië, 90050-170
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- Irmandade da Santa Casa de Misericórdia de Porto Alegre
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Porto Alegre, Brazilië, 90035-000
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- Instituto de Pesquisa Clínica - Hospital Moinhos de Vento
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Porto Alegre, Brazilië, 90610-000
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- HPT São Lucas da PUCRS - UBEA
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Porto Alegre, Brazilië, 90035-903
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- Hospital de Clínicas de Porto Alegre
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São José do Rio Preto, Brazilië, 15090-000
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- Fundação Faculdade Regional de Medicina de São José do Rio Petro
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São Paulo, Brazilië, 01308-050
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- Hospital Sirio Libanês
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São Paulo, Brazilië, 01401-002
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Montreal, Canada, H3T 1E2
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- Jewish General Hospital
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St. John's, Canada, A1V 3V6
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- Health Sciences Centre
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Toronto, Canada, M5G 2M9
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- Princess Margaret Cancer C
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Wuhan, China, 430048
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- Union Hospital
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Anhui
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Hefei, Anhui, China, 230001
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- Anhui Provincial Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100142
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- Beijing Cancer Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, China, 400010
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- The Second Affiliated Hospital of Chongqing Medical University
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Fujian
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Fuzhou, Fujian, China, 350014
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- Fujian Provincial Cancer Hospital
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Xiamen, Fujian, China, 361003
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- First Affiliated Hospital of Xiamen University
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Gansu
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Lanzhou, Gansu, China, 730050
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Guangdong
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Guangzhou, Guangdong, China, 510080
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- The First Affiliated Hospital of Sun Yat-sen University
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Shantou, Guangdong, China, 515063
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- Cancer Hospital of Shantou University Medical College
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Guangxi
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Nanning, Guangxi, China, 530200
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- Guangxi Medical University Affiliated Tumor Hospital
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Heilongjiang
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Harbin, Heilongjiang, China, 150091
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- Harbin Medical University Cancer Hospital
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Henan
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Henan, Henan, China, 450003
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- Henan Cancer Hospital
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Zhengzhou, Henan, China, 450014
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- The Second Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan, Hubei, China, 430079
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- Hubei Cancer Hospital
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Xiangyang, Hubei, China, 441138
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- Xiangyang Central Hospital
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Jiangsu
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Nanjing, Jiangsu, China, 210008
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- The Affiliated Hospital of Nanjing University Medical School
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Jiangxi
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Nanchang, Jiangxi, China, 330006
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- Jiangxi Maternal and Child Health Hospital
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Jilin
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Changchun, Jilin, China, 130021
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- The First Hospital of Jilin University
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Shaanxi
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Xi'an, Shaanxi, China, 710061
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- The First Affiliated Hospital of Xian Jiaotong University
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Shandong
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Jinan, Shandong, China, 250117
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- Cancer Hospital of Shandong First Medical University
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Jining, Shandong, China, 272029
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- Affiliated Hospital of Jining Medical University
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Linyi, Shandong, China, 276001
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- Linyi Cancer Hospital
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Yantai, Shandong, China, 264000
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- Yantai Yuhuangding Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200032
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- Fudan University Shanghai Cancer Center
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Shanghai, Shanghai Municipality, China, 200011
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- Obstetrics & Gynecology Hospital of Fudan University
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Sichuan
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Chengdu, Sichuan, China, 610072
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- Sichuan Provincial People's Hospital
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Tianjin Municipality
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Tianjin, Tianjin Municipality, China, 300060
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- Tianjin Medical University Cancer Institute & Hospital
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Zhejiang
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Hangzhou, Zhejiang, China, 310022
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- Zhejiang Cancer Hospital
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Wenzhou, Zhejiang, China, 325015
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- The First Affiliated Hospital of Wenzhou Medical University
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Aalborg, Denemarken, 9000
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- Aalborg Universit Hospital
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Copenhagen, Denemarken, 2100
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- Rigshospitalet
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Herlev, Denemarken, 2730
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- Herlev og Gentofte Hospital
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Odense, Denemarken, 5000
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- Odense University Hospital
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Berlin, Duitsland, 13353
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- Charité - Campus Virchow-Klinikum
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Essen, Duitsland, 45136
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- Kliniken Essen-Mitte
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Kassel, Duitsland, 34125
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- Klinkum Kassel
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München, Duitsland, 81377
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- LMU-Campus Innenstadt
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Tübingen, Duitsland, 72076
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- Universitaets-Frauenklinik, Tübingen
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Kuopio, Finland, 70210
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- Kuopio University HPT
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Oulu, Finland, 90029
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- OYS Naisten poliklinikka
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Turku, Finland, 20521
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- Turun yliopistollinen keskussairaala
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Angers, Frankrijk, 49055
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- ICO - Site Paul Papin
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Besançon, Frankrijk, 25000
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- CHU Besançon Service Oncologie
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Caen, Frankrijk, 14000
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- Centre François Baclesse
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Le Mans, Frankrijk, 72000
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- Clinique Victor Hugo - Centre Jean Bernard
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Marseille, Frankrijk, 13015
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- Hôpital Nord Bâtiment Mistral
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Paris, Frankrijk, 75010
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- Hôpital Saint Louis
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Saint-Herblain, Frankrijk, 44800
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- ICO - Site René Gauducheau
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Strasbourg, Frankrijk, 67000
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- Institut de Cancérologie de Strasbourg Europe - ICANS
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Vandœuvre-lès-Nancy, Frankrijk, 54519
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- Institut de Cancérologie de Lorraine
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Athens, Griekenland, 11528
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- Alexandra General Hospital of Athens
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Athens, Griekenland, 11528
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- Aretaieio Hospital
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Chaïdári, Griekenland, 124 62
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- University General Hospital Attikon
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Kalamata, Griekenland, 24100
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- General Hospital of Kalamata
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Marousi, Griekenland, 151 23
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- IASO General Clinic
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Budapest, Hongarije, 1088
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- Semmelweis Egyetem
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Budapest, Hongarije, 1122
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- Országos Onkológiai Intézet
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Debrecen, Hongarije, 4032
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- Debreceni Egyetem
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Kecskemét, Hongarije, 6000
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- Bács-Kiskun Vármegyei Oktatókórház
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Zalaegerszeg, Hongarije, 8900
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- Zala Varmegyei Szent Rafael Korhaz
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Hadera, Israël, 382302
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- Hillel Yaffe Medical Center
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Haifa, Israël, 3436212
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- Lady Davis Carmel Medical Center
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Jerusalem, Israël, 9103102
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- Shaare Zedek Medical Center
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Jerusalem, Israël, 9112001
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- Hadassah Ein Kerem Medical Center
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Jerusalem, Israël, 9103102
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- Shaare Zedek
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Petah Tikva, Israël, 4941492
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- Rabin Medical Center-Beilinson Campus
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Ramat Gan, Israël, 5265601
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- Sheba Medical Center
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Tel Aviv, Israël, 642390
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- Sourasky Medical Centre
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Bari, Italië, 70124
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- Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
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Bologna, Italië, 40138
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- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
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Catania, Italië, 95126
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- Azienda Ospedaliera Cannizzaro - Oncologia
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Meldola, Italië, 47014
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- IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST)
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Milan, Italië, 20132
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- Ospedale San Raffaele
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Milan, Italië, 20133
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- Istituto Nazionale dei Tumori
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Milan, Italië, 20141
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- Istituto Europeo di Oncologia
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Milan, Italië, 20159
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- Humanitas San Pio X
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Naples, Italië, 80131
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- Istituto Nazionale Tumori Fondazione G. Pascale
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Roma, Italië, 00168
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- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Torino, Italië, 10128
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- Azienda Ospedaliera Ordine Mauriziano Umberto I di Torino
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Nijmegen, Nederland, 6525 GA
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- Radboud UMC
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Rotterdam, Nederland, 3015 AA
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- Erasmus Medisch Centrum
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Oslo, Noorwegen, 0379
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- Oslo University Hospital
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Stavanger, Noorwegen, 4011
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- Stavanger University Hospital
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Innsbruck, Oostenrijk, 6020
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- Medizinische Universität Innsbruck
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Vienna, Oostenrijk, A-1090
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- Medical University of Vienna
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Bialystok, Polen, 15-027
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- Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie
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Poznan, Polen, 60-569
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- Uniwersytecki Szpital Kliniczny w Poznaniu
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Siedlce, Polen, 08-110
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- Siedleckie Centrum Onkologii
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Singapore, Singapore, 168583
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- National Cancer Centre Singapore
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Singapore, Singapore, 258499
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- OncoCare Cancer Centre
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A Coruña, Spanje, 15006
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- Complejo Hospitalario Universitario A Coruña
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Barcelona, Spanje, 08036
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- Hospital Clinic de Barcelona
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Barcelona, Spanje, 08035
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- Hospital Universitari Vall, d'Hebron
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Córdoba, Spanje, 14004
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- Hospital Universitario Reina Sofia
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Donostia / San Sebastian, Spanje, 20014
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- Hospital Universitar Donostia
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Girona, Spanje, 17007
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- Institut Català d'Oncologia (ICO) Hospital Universitari de Girona Dr. Josep Trueta
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Jaén, Spanje, 23007
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- Hospital Universitario de Jaén
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Madrid, Spanje, 28041
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- Hospital Universitario 12 de Octubre
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Madrid, Spanje, 28046
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- Hospital Universitario La Paz
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Madrid, Spanje, 28034
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Palma de Mallorca, Spanje, 07120
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- Hospital Universit Son Espases
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Valencia, Spanje, 46009
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- Instituto Valenciano de Oncología - Valencia
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Valencia, Spanje, 46026
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- Hospital Univers Politec La Fe
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Taichung, Taiwan, 40705
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- Taichung Veterans General Hospital
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Taichung, Taiwan, 40447
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- China Medical University Hospital
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Taichung, Taiwan, 433004
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- Kuang Tien General Hospital
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Tainan, Taiwan, 70457
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- National Cheng Kung University Hospital
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Taipei, Taiwan, 11217
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- Taipei Veterans General Hospital
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Taipei, Taiwan, 10449
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- MacKay Memorial Hospital_ Taipei Branch
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Brno, Tsjechië, 60200
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- Gynekologicko-porodnická klinika, Fakultni nemocnice Brno
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Olomouc, Tsjechië, 77900
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- University Hospital Olomouc - Onkologická klinika- Fakultni
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Ostrava, Tsjechië, 01790
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- Fakultní nemocnice Ostrava
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Prague, Tsjechië, 12808
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- Vseobecna fakultni nemocnice v Praze
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Prague, Tsjechië, 15000
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- Fakultní nemocnice Motol a Homolka
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Prague, Tsjechië, 18081
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Adana, Turkije (Türkiye), 01120
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- Baskent University Adana Application and Research Center
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Ankara, Turkije (Türkiye), 06490
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- Baskent University Ankara Hospital
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Ankara, Turkije (Türkiye), 06200
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- Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
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Ankara, Turkije (Türkiye), 06230
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- Hacettepe University
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Bayraklı, Turkije (Türkiye), 35540
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- İzmir City Hospital
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Istanbul, Turkije (Türkiye), 34093
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- Istanbul University Istanbul Medical Faculty
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Istanbul, Turkije (Türkiye), 34093
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Brighton, Verenigd Koninkrijk, BN2 1ES
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- Royal Sussex County Hospital
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Bristol, Verenigd Koninkrijk, BS2 8ED
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- Bristol Haematology and Oncology Centre
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Cambridge, Verenigd Koninkrijk, CB2 0QQ
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- Addenbrooke's Hospital
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Cottingham, Verenigd Koninkrijk, HU165JQ
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- Castle Hill Hospital
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Coventry, Verenigd Koninkrijk, CV2 2DX
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- Warwick Hospital
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Edinburgh, Verenigd Koninkrijk, EH4 2XU
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- Western General Hospital
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Exeter, Verenigd Koninkrijk, EX2 5DW
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- Royal Devon & Exeter HPT
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London, Verenigd Koninkrijk, SE1 9RT
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- Guy's Hospital
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London, Verenigd Koninkrijk, NW1 2PG
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- University College London Hospitals
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Middlesex, Verenigd Koninkrijk, HA6 2RN
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- Mount Vermont Cancer Center
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Nottingham, Verenigd Koninkrijk, NG5 1PB
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- Nottingham University Hospitals NHS Trust
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Swansea, Verenigd Koninkrijk, SA2 8QA
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- Singleton Hospital
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Truro, Verenigd Koninkrijk, TR1 3LJ
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- Royal Cornwall Hospital
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California
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Los Angeles, California, Verenigde Staten, 90033
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- USC/Norris Cancer Center
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045
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- University of Colorado Cancer Center
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Connecticut
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New Haven, Connecticut, Verenigde Staten, 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, Verenigde Staten, 20010
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- MedStar Washington Hospital Center
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Florida
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Fort Lauderdale, Florida, Verenigde Staten, 33316
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- Broward Health Medical Center
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Illinois
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Peoria, Illinois, Verenigde Staten, 61637
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- OSF Saint Francis Medical Center
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Urbana, Illinois, Verenigde Staten, 61801
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- Carle Cancer Institute
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Kentucky
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Lexington, Kentucky, Verenigde Staten, 40503
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- Baptist Health Lexington
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Louisiana
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Shreveport, Louisiana, Verenigde Staten, 71103
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- WK Cancer Center
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 55404
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- Minnesota Oncology
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Nevada
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Reno, Nevada, Verenigde Staten, 89511
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- The Center of Hope Reno
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New York
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Mineola, New York, Verenigde Staten, 11501
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- NYU Langone Hospital - Long Island
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New York, New York, Verenigde Staten, 10016
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- NYU Langone Health
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Syracuse, New York, Verenigde Staten, 13210
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- SUNY Upstate Medical University
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Ohio
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Centerville, Ohio, Verenigde Staten, 45459
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- Miami Valley Hospital South
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Hilliard, Ohio, Verenigde Staten, 43026
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- Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73104
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- Peggy & Charles Stephenson Oklahoma Cancer Center
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Pennsylvania
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Willow Grove, Pennsylvania, Verenigde Staten, 19090
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- Asplundh Cancer Pavilion
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South Dakota
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Sioux Falls, South Dakota, Verenigde Staten, 57104
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- Sanford Cancer Center
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Texas
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Tyler, Texas, Verenigde Staten, 75702
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- Texas Oncology, P.A.
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Utah
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Murray, Utah, Verenigde Staten, 84107-5701
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- Intermountain Healthcare
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Virginia
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Norfolk, Virginia, Verenigde Staten, 23502
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- Virginia Oncology Associates
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Changwon, Zuid -Korea, 51353
- Werving
- Samsung Changwon Hospital
-
Daegu, Zuid -Korea, 42601
- Werving
- Keimyung Univty Dongsan Hospital
-
Goyang, Zuid -Korea, 10408
- Werving
- National Cancer Center
-
Seongnam, Zuid -Korea, 13620
- Werving
- Seoul National University Bundang Hospital
-
Seongnam-si, Zuid -Korea, 13496
- Werving
- CHA Bundang Medical Center
-
Seoul, Zuid -Korea, 05505
- Werving
- Asan Medical Center
-
Seoul, Zuid -Korea, 03080
- Werving
- Seoul National University Hospital
-
Seoul, Zuid -Korea, 03722
- Werving
- Severance Hospital, Yonsei University Health System
-
Seoul, Zuid -Korea, 06351
- Werving
- Samsung Medical Center
-
Seoul, Zuid -Korea, 02841
- Werving
- Korea University Anam Hospital
-
Seoul, Zuid -Korea, 06591
- Werving
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
Seoul, Zuid -Korea, 07804
- Werving
- Ewha Womans University Seoul Hospital
-
Seoul, Zuid -Korea, 06273
- Werving
- Gangnam Severance Hospital, Yonsei University Health System
-
-
-
-
-
Lund, Zweden, 222 42
- Werving
- Skånes Universitetssjukhus Lund
-
Stockholm, Zweden, 17176
- Werving
- Karolinska University Hospital
-
Uppsala, Zweden, 75185
- Werving
- Akademiska Sjukhuset
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Cohort 1 (HER2 IHC score 1+ of 2+): BNT323/DB-1303
|
intravenous (IV) infusion
Andere namen:
|
|
Experimenteel: Cohort 2 (HER2 IHC score 3+) - BNT323/DB-1303
|
intravenous (IV) infusion
Andere namen:
|
|
Actieve vergelijker: 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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Cohort 1: PFS assessed by blinded independent central review (BICR) in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Cohort 2: Percentage van deelnemers met HER2 IHC 3+ recidiverend endometriumcarcinoom met optreden van TEAEs leidend tot onderbreking van medicatie, dosisvermindering of stopzetting van de studiebehandeling.
Tijdsspanne: Tot 35 dagen na de laatste dosis van de studiebehandeling
|
Tot 35 dagen na de laatste dosis van de studiebehandeling
|
|
|
Cohort 1: Overall survival (OS) in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: BioNTech Responsible Person, BioNTech SE
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
10 juni 2025
Primaire voltooiing (Geschat)
1 maart 2028
Studie voltooiing (Geschat)
1 november 2029
Studieregistratiedata
Eerst ingediend
25 maart 2024
Eerst ingediend dat voldeed aan de QC-criteria
25 maart 2024
Eerst geplaatst (Werkelijk)
1 april 2024
Updates van studierecords
Laatste update geplaatst (Werkelijk)
10 november 2026
Laatste update ingediend die voldeed aan QC-criteria
9 november 2026
Laatst geverifieerd
1 november 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
- Immuun checkpoint-remmer
- Antilichaamgeneesmiddelconjugaat (ADC)
- Op platina gebaseerde therapie
- Menselijke epidermale groeifactorreceptor 2 (HER2)
- Tumoren die HER2 tot expressie brengen
- Recidiverende endometriumkanker
- IHC scoort 1+, 2+ en 3+
- HER2-eiwitexpressie
- Endometriumkanker die HER2 tot expressie brengt
- ErbB-2-receptor
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Genitale ziekten
- Urogenitale neoplasmata
- Neoplasmata per site
- Neoplasmata
- Vrouwelijke urogenitale ziekten
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Baarmoeder Ziekten
- Genitale ziekten, vrouw
- Genitale neoplasmata, vrouwelijk
- Baarmoeder Neoplasmata
- Endometriumneoplasmata
- Organische chemicaliën
- Koolwaterstoffen
- Cycloparaffins
- Koolwaterstoffen, alicyclisch
- Koolwaterstoffen, cyclisch
- Terpenen
- Koolhydraten
- Polycyclische aromatische koolwaterstoffen
- Koolwaterstoffen, aromatisch
- Polycyclische verbindingen
- Glycosiden
- Taxoids
- Cyclodecanes
- Diterpenen
- Antracyclines
- Naftacenes
- Aminoglycosides
- Daunorubicine
- Docetaxel
- Doxorubicine
- Paclitaxel
Andere studie-ID-nummers
- BNT323-01
- GOG-3105 (Andere identificatie: Gynecologic Oncology Group Foundation)
- ENGOT- EN25/NSGO-CTU (Andere identificatie: European Network for Gynaecological Oncological Trial and Nordic Society of Gynaecological Oncology Clinical Trial Unit)
- 2023 (Subsidie/contract van de Amerikaanse NIH)
- 2023-507525-42-00 (Ctis)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .