A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer
Start Date
6/10/2025
Completion Date
11/1/2029
Summary
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.
Detailed Description
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
BNT323/DB-1303
Doxorubicin
Paclitaxel
Docetaxel
Conditions
Locations
MedStar Washington Hospital Center
Washington D.C., District of Columbia 20010
United States
Broward Health Medical Center
Fort Lauderdale, Florida 33316
United States
The Center of Hope Reno
Reno, Nevada 89511
United States
NYU Langone Hospital - Long Island
Mineola, New York 11501
United States
NYU Langone Health
New York, New York 10016
United States
Miami Valley Hospital South
Centerville, Ohio 45459
United States
Ohio State University
Hilliard, Ohio 43026
United States
Sanford Cancer Center
Sioux Falls, South Dakota 57104
United States
Hospital Británico de Buenos Aires
Buenos Aires, C1280AEB
Argentina
Investigaciones CORI S.R.L.
La Rioja, F5300COE
Argentina
Hospital Provincial del Centenario
Rosario, S2002KDS
Argentina
Centro Oncológico de Excelencia
San Juan, 5400
Argentina
Adelaide Oncology & Haematology
Adelaide, 5000
Australia
Cancer Research SA
Adelaide, 5000
Australia
Monash Health Clinical Trial Center
Clayton, 3168
Australia
Gosford Hospital
Gosford, 2250
Australia
Peter MacCallum Cancer Centre
Melbourne, 3000
Australia
Frankston Hospital
Melbourne, VIC 3199
Australia
Shoalhaven Cancer Care Centre
Nowra, 2541
Australia
Sunshine Hospital
Saint Albans, 3021
Australia
Mater Hospital Brisbane
South Brisbane, 4001
Australia
Wollongong Hospital
Wollongong, 2500
Australia
Institut Jules Bordet
Brussels, 1070
Belgium
Universitair Ziekenhuis Gent
Ghent, 9000
Belgium
AZ Groeninge VZW
Kortrijk, 8500
Belgium
UZ Leuven
Leuven, 3000
Belgium
CHU UCL Namur-Sainte-Elisabeth
Namur, B5000
Belgium
Fundação Sao Francisco Xavier
Ipatinga, 35162-189
Brazil
Hospital de Clínicas de Passo Fundo
Passo Fundo, 99010-260
Brazil
Instituto de Pesquisa Clínica - Hospital Moinhos de Vento
Porto Alegre, 90035-000
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, 90035-903
Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, 90050-170
Brazil
HPT São Lucas da PUCRS - UBEA
Porto Alegre, 90610-000
Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Petro
São José do Rio Preto, 15090-000
Brazil
Hospital Sirio Libanês
São Paulo, 01308-050
Brazil
Inst D'Or de Pesquisa E Ensino
São Paulo, 01401-002
Brazil
Jewish General Hospital
Montreal, H3T 1E2
Canada
Health Sciences Centre
St. John's, A1V 3V6
Canada
Princess Margaret Cancer C
Toronto, M5G 2M9
Canada
Anhui Provincial Hospital
Hefei, Anhui 230001
China
Beijing Cancer Hospital
Beijing, Beijing Municipality 100142
China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality 400010
China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian 350014
China
First Affiliated Hospital of Xiamen University
Xiamen, Fujian 361003
China
Gansu Provincial Maternity and Child-care Hospital
Lanzhou, Gansu 730050
China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong 510080
China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong 515063
China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi 530200
China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang 150091
China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450014
China
Hubei Cancer Hospital
Wuhan, Hubei 430079
China
Xiangyang Central Hospital
Xiangyang, Hubei 441138
China
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu 210008
China
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi 330006
China
The First Hospital of Jilin University
Changchun, Jilin 130021
China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi 710061
China
Cancer Hospital of Shandong First Medical University
Jinan, Shandong 250117
China
Affiliated Hospital of Jining Medical University
Jining, Shandong 272029
China
Linyi Cancer Hospital
Linyi, Shandong 276001
China
Yantai Yuhuangding Hospital
Yantai, Shandong 264000
China
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality 200011
China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality 200032
China
Sichuan Provincial People's Hospital
Chengdu, Sichuan 610072
China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality 300060
China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang 310022
China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang 325015
China
Gynekologicko-porodnická klinika, Fakultni nemocnice Brno
Brno, 60200
Czechia
University Hospital Olomouc - Onkologická klinika- Fakultni
Olomouc, 77900
Czechia
Fakultní nemocnice Ostrava
Ostrava, 01790
Czechia
Fakultní nemocnice Motol a Homolka
Prague, 15000
Czechia
Fakultní nemocnice Bulovka
Prague, 18081
Czechia
Aalborg Universit Hospital
Aalborg, 9000
Denmark
Rigshospitalet
Copenhagen, 2100
Denmark
Herlev og Gentofte Hospital
Herlev, 2730
Denmark
Odense University Hospital
Odense, 5000
Denmark
Kuopio University HPT
Kuopio, 70210
Finland
OYS Naisten poliklinikka
Oulu, 90029
Finland
Turun yliopistollinen keskussairaala
Turku, 20521
Finland
ICO - Site Paul Papin
Angers, 49055
France
CHU Besançon Service Oncologie
Besançon, 25000
France
Centre François Baclesse
Caen, 14000
France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, 72000
France
Hôpital Nord Bâtiment Mistral
Marseille, 13015
France
Hôpital Saint Louis
Paris, 75010
France
ICO - Site René Gauducheau
Saint-Herblain, 44800
France
Institut de Cancérologie de Strasbourg Europe - ICANS
Strasbourg, 67000
France
Alexandra General Hospital of Athens
Athens, 11528
Greece
Aretaieio Hospital
Athens, 11528
Greece
University General Hospital Attikon
Chaïdári, 124 62
Greece
General Hospital of Kalamata
Kalamata, 24100
Greece
IASO General Clinic
Marousi, 151 23
Greece
Debreceni Egyetem
Debrecen, 4032
Hungary
Bács-Kiskun Vármegyei Oktatókórház
Kecskemét, 6000
Hungary
Lady Davis Carmel Medical Center
Haifa, 3436212
Israel
Hadassah Ein Kerem Medical Center
Jerusalem, 9112001
Israel
Rabin Medical Center-Beilinson Campus
Petah Tikva, 4941492
Israel
Sheba Medical Center
Ramat Gan, 5265601
Israel
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
Bari, 70124
Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna, 40138
Italy
Azienda Ospedaliera Cannizzaro - Oncologia
Catania, 95126
Italy
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST)
Meldola, 47014
Italy
Ospedale San Raffaele
Milan, 20132
Italy
Istituto Nazionale dei Tumori
Milan, 20133
Italy
Istituto Europeo di Oncologia
Milan, 20141
Italy
Humanitas San Pio X
Milan, 20159
Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, 80131
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Italy
Azienda Ospedaliera Ordine Mauriziano Umberto I di Torino
Torino, 10128
Italy
Radboud UMC
Nijmegen, 6525 GA
Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 AA
Netherlands
Oslo University Hospital
Oslo, 0379
Norway
Stavanger University Hospital
Stavanger, 4011
Norway
Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie
Bialystok, 15-027
Poland
Siedleckie Centrum Onkologii
Siedlce, 08-110
Poland
National Cancer Centre Singapore
Singapore, 168583
Singapore
Samsung Changwon Hospital
Changwon, 51353
South Korea
Keimyung Univty Dongsan Hospital
Daegu, 42601
South Korea
National Cancer Center
Goyang, 10408
South Korea
Seoul National University Bundang Hospital
Seongnam, 13620
South Korea
CHA Bundang Medical Center
Seongnam-si, 13496
South Korea
Korea University Anam Hospital
Seoul, 02841
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
South Korea
Ewha Womans University Seoul Hospital
Seoul, 07804
South Korea
Hospital Universitari Vall, d'Hebron
Barcelona, 08035
Spain
Hospital Clinic de Barcelona
Barcelona, 08036
Spain
Hospital Universitario Reina Sofia
Córdoba, 14004
Spain
Hospital Universitar Donostia
Donostia / San Sebastian, 20014
Spain
Institut Català d'Oncologia (ICO) Hospital Universitari de Girona Dr. Josep Trueta
Girona, 17007
Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Hospital Universitario La Paz
Madrid, 28046
Spain
Instituto Valenciano de Oncología - Valencia
Valencia, 46009
Spain
Skånes Universitetssjukhus Lund
Lund, 222 42
Sweden
Karolinska University Hospital
Stockholm, 17176
Sweden
China Medical University Hospital
Taichung, 40447
Taiwan
Taichung Veterans General Hospital
Taichung, 40705
Taiwan
Kuang Tien General Hospital
Taichung, 433004
Taiwan
National Cheng Kung University Hospital
Tainan, 70457
Taiwan
MacKay Memorial Hospital_ Taipei Branch
Taipei, 10449
Taiwan
Taipei Veterans General Hospital
Taipei, 11217
Taiwan
Baskent University Adana Application and Research Center
Adana, 01120
Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
Ankara, 06200
Turkey (Türkiye)
Hacettepe University
Ankara, 06230
Turkey (Türkiye)
Baskent University Ankara Hospital
Ankara, 06490
Turkey (Türkiye)
İzmir City Hospital
Bayraklı, 35540
Turkey (Türkiye)
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
Istanbul, 34093
Turkey (Türkiye)
Royal Sussex County Hospital
Brighton, BN2 1ES
United Kingdom
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED
United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 0QQ
United Kingdom
Castle Hill Hospital
Cottingham, HU165JQ
United Kingdom
Western General Hospital
Edinburgh, EH4 2XU
United Kingdom
Royal Devon & Exeter HPT
Exeter, EX2 5DW
United Kingdom
University College London Hospitals
London, NW1 2PG
United Kingdom
Guy's Hospital
London, SE1 9RT
United Kingdom
Mount Vermont Cancer Center
Middlesex, HA6 2RN
United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB
United Kingdom
Singleton Hospital
Swansea, SA2 8QA
United Kingdom
Royal Cornwall Hospital
Truro, TR1 3LJ
United Kingdom