Actively Recruiting
A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer
Led by BioNTech SE · Updated on 2026-04-24
480
Participants Needed
132
Research Sites
229 weeks
Total Duration
On this page
Sponsors
B
BioNTech SE
Lead Sponsor
D
DualityBio Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female adults aged 18 years or older who provide informed consent
- Histologically confirmed recurrent endometrial cancer with HER2 IHC score of 1+, 2+ (Cohort 1) or 3+ (Cohort 2) by central lab testing
- Tumors not classified as true sarcomas; uterine carcinosarcoma allowed
- Measurable disease as defined by RECIST v1.1
- ECOG Performance Status of 0, 1, or 2
- Recurrence within 12 months after platinum-based adjuvant chemotherapy for Stage I-III disease or recurrence after platinum-based chemotherapy in recurrent/metastatic setting
- Prior treatment with immune checkpoint inhibitors
- Life expectancy of at least 12 weeks at screening
You will not qualify if you...
- Ineligibility for all chemotherapy options in investigator's choice arm (Cohort 1 only)
- History of small bowel obstruction requiring hospitalization within 3 months before first treatment dose
- Uncontrolled intercurrent illness limiting study compliance or increasing risk of adverse events
- Clinically uncontrolled pleural effusion, ascites, pericardial effusion requiring drainage, or peritoneal shunt within 2 weeks before first treatment dose
- History or current interstitial lung disease or pneumonitis requiring steroids, or suspected but unruled-out ILD/pneumonitis at screening
- Use of immunosuppressive medication within 14 days before first treatment dose, except certain corticosteroids
- Lung-specific illnesses or autoimmune disorders with lung involvement, or prior complete pneumonectomy
- Uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks before treatment
- Unresolved toxicities from previous anti-cancer therapy above Grade 1 or baseline except controlled alopecia, fatigue, or endocrinopathies
- Pregnancy, breastfeeding, or plans for pregnancy during the study or within 7 months after last treatment dose
- History of allergies or intolerance to study treatments or monoclonal antibodies unless desensitization was successful
- Prior treatment with topoisomerase I inhibitors including ADCs
- Left ventricular ejection fraction below 55% or tissue doppler E/e' ratio greater than 15 within 28 days before first treatment dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 132 locations
1
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
2
Broward Health Medical Center
Fort Lauderdale, Florida, United States, 33316
Actively Recruiting
3
The Center of Hope Reno
Reno, Nevada, United States, 89511
Actively Recruiting
4
Laura & Isaac Perlmutter Cancer Center
New York, New York, United States, 10016
Actively Recruiting
5
Miami Valley Hospital South
Centerville, Ohio, United States, 45459
Actively Recruiting
6
Ohio State University
Hilliard, Ohio, United States, 43026
Actively Recruiting
7
Hospital Británico de Buenos Aires
Buenos Aires, Argentina, C1280AEB
Actively Recruiting
8
Investigaciones CORI S.R.L.
La Rioja, Argentina, F5300COE
Actively Recruiting
9
Hospital Provincial del Centenario
Rosario, Argentina, S2002KDS
Actively Recruiting
10
Centro Oncológico de Excelencia
San Juan, Argentina, 5400
Actively Recruiting
11
Adelaide Oncology & Haematology
Adelaide, Australia, 5000
Actively Recruiting
12
Cancer Research SA
Adelaide, Australia, 5000
Actively Recruiting
13
Gosford Hospital
Gosford, Australia, 2250
Actively Recruiting
14
Frankston Hospital
Melbourne, Australia, VIC 3199
Actively Recruiting
15
Shoalhaven Cancer Care Centre
Nowra, Australia, 2541
Actively Recruiting
16
Sunshine Hospital
Saint Albans, Australia, 3021
Actively Recruiting
17
Mater Hospital Brisbane
South Brisbane, Australia, 4001
Actively Recruiting
18
Wollongong Hospital
Wollongong, Australia, 2500
Actively Recruiting
19
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
20
AZ Groeninge VZW
Kortrijk, Belgium, 8500
Actively Recruiting
21
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
22
CHU UCL Namur-Sainte-Elisabeth
Namur, Belgium, B5000
Actively Recruiting
23
Fundação Sao Francisco Xavier
Ipatinga, Brazil, 35162-189
Actively Recruiting
24
Hospital de Clínicas de Passo Fundo
Passo Fundo, Brazil, 99010-260
Actively Recruiting
25
Instituto de Pesquisa Clínica - Hospital Moinhos de Vento
Porto Alegre, Brazil, 90035-000
Actively Recruiting
26
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil, 90035-903
Actively Recruiting
27
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil, 90050-170
Actively Recruiting
28
HPT São Lucas da PUCRS - UBEA
Porto Alegre, Brazil, 90610-000
Actively Recruiting
29
Fundação Faculdade Regional de Medicina de São José do Rio Petro
São José do Rio Preto, Brazil, 15090-000
Actively Recruiting
30
Hospital Sirio Libanês
São Paulo, Brazil, 01308-050
Actively Recruiting
31
Inst D'Or de Pesquisa E Ensino
São Paulo, Brazil, 01401-002
Actively Recruiting
32
Jewish General Hospital
Montreal, Canada, H3T 1E2
Actively Recruiting
33
Health Sciences Centre
St. John's, Canada, A1V 3V6
Actively Recruiting
34
Princess Margaret Cancer C
Toronto, Canada, M5G 2M9
Actively Recruiting
35
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
Actively Recruiting
36
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
37
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010
Actively Recruiting
38
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China, 350014
Actively Recruiting
39
First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
40
Gansu Provincial Maternity and Child-care Hospital
Lanzhou, Gansu, China, 730050
Actively Recruiting
41
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Actively Recruiting
42
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China, 515063
Actively Recruiting
43
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, China, 530200
Actively Recruiting
44
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150091
Actively Recruiting
45
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450014
Actively Recruiting
46
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Actively Recruiting
47
Xiangyang Central Hospital
Xiangyang, Hubei, China, 441138
Actively Recruiting
48
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Actively Recruiting
49
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China, 330006
Actively Recruiting
50
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
51
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
52
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250117
Actively Recruiting
53
Affiliated Hospital of Jining Medical University
Jining, Shandong, China, 272029
Actively Recruiting
54
Linyi Cancer Hospital
Linyi, Shandong, China, 276001
Actively Recruiting
55
Yantai Yuhuangding Hospital
Yantai, Shandong, China, 264000
Actively Recruiting
56
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
57
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
58
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Actively Recruiting
59
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
60
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
61
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325015
Actively Recruiting
62
Fakultní nemocnice Motol a Homolka
Prague, Czechia, 15000
Actively Recruiting
63
Fakultní nemocnice Bulovka
Prague, Czechia, 18081
Actively Recruiting
64
Aalborg Universit Hospital
Aalborg, Denmark, 9000
Actively Recruiting
65
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
66
Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
67
Kuopio University HPT
Kuopio, Finland, 70210
Actively Recruiting
68
OYS Naisten poliklinikka
Oulu, Finland, 90029
Actively Recruiting
69
ICO - Site Paul Papin
Angers, France, 49055
Actively Recruiting
70
CHU Besançon Service Oncologie
Besançon, France, 25000
Actively Recruiting
71
Centre François Baclesse
Caen, France, 14000
Actively Recruiting
72
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, France, 72000
Actively Recruiting
73
Hôpital Nord Bâtiment Mistral
Marseille, France, 13015
Actively Recruiting
74
Hôpital Saint Louis
Paris, France, 75010
Actively Recruiting
75
ICO - Site René Gauducheau
Saint-Herblain, France, 44800
Actively Recruiting
76
Institut de Cancérologie de Strasbourg Europe - ICANS
Strasbourg, France, 67000
Actively Recruiting
77
Alexandra General Hospital of Athens
Athens, Greece, 11528
Actively Recruiting
78
Aretaieio Hospital
Athens, Greece, 11528
Actively Recruiting
79
University General Hospital Attikon
Chaïdári, Greece, 124 62
Actively Recruiting
80
General Hospital of Kalamata
Kalamata, Greece, 24100
Actively Recruiting
81
IASO General Clinic
Marousi, Greece, 151 23
Actively Recruiting
82
Debreceni Egyetem
Debrecen, Hungary, 4032
Actively Recruiting
83
Bács-Kiskun Vármegyei Oktatókórház
Kecskemét, Hungary, 6000
Actively Recruiting
84
Lady Davis Carmel Medical Center
Haifa, Israel, 3436212
Actively Recruiting
85
Hadassah Ein Kerem Medical Center
Jerusalem, Israel, 9112001
Actively Recruiting
86
Rabin Medical Center-Beilinson Campus
Petah Tikva, Israel, 4941492
Actively Recruiting
87
Sheba Medical Center
Ramat Gan, Israel, 5265601
Actively Recruiting
88
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
Bari, Italy, 70124
Actively Recruiting
89
Azienda Ospedaliera Cannizzaro - Oncologia
Catania, Italy, 95126
Actively Recruiting
90
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST)
Meldola, Italy, 47014
Actively Recruiting
91
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
92
Humanitas San Pio X
Milan, Italy, 20159
Actively Recruiting
93
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
94
Azienda Ospedaliera Ordine Mauriziano Umberto I di Torino
Torino, Italy, 10128
Actively Recruiting
95
Radboud UMC
Nijmegen, Netherlands, 6525 GA
Actively Recruiting
96
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 AA
Actively Recruiting
97
Stavanger University Hospital
Stavanger, Norway, 4011
Actively Recruiting
98
Samsung Changwon Hospital
Changwon, South Korea, 51353
Actively Recruiting
99
Keimyung Univty Dongsan Hospital
Daegu, South Korea, 42601
Actively Recruiting
100
National Cancer Center
Goyang, South Korea, 10408
Actively Recruiting
101
Seoul National University Bundang Hospital
Seongnam, South Korea, 13620
Actively Recruiting
102
CHA Bundang Medical Center
Seongnam-si, South Korea, 13496
Actively Recruiting
103
Korea University Anam Hospital
Seoul, South Korea, 02841
Actively Recruiting
104
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
105
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
106
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
107
Gangnam Severance Hospital, Yonsei University Health System
Seoul, South Korea, 06273
Actively Recruiting
108
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
109
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea, 06591
Actively Recruiting
110
Ewha Womans University Seoul Hospital
Seoul, South Korea, 07804
Actively Recruiting
111
Hospital Universitario Reina Sofia
Córdoba, Spain, 14004
Actively Recruiting
112
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
113
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
114
Skånes Universitetssjukhus Lund
Lund, Sweden, 222 42
Actively Recruiting
115
Karolinska University Hospital
Stockholm, Sweden, 17176
Actively Recruiting
116
China Medical University Hospital
Taichung, Taiwan, 40447
Actively Recruiting
117
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
118
Kuang Tien General Hospital
Taichung, Taiwan, 433004
Actively Recruiting
119
National Cheng Kung University Hospital
Tainan, Taiwan, 70457
Actively Recruiting
120
MacKay Memorial Hospital_ Taipei Branch
Taipei, Taiwan, 10449
Actively Recruiting
121
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
122
Royal Sussex County Hospital
Brighton, United Kingdom, BN2 1ES
Actively Recruiting
123
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Actively Recruiting
124
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
125
Castle Hill Hospital
Cottingham, United Kingdom, HU165JQ
Actively Recruiting
126
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Actively Recruiting
127
Royal Devon & Exeter HPT
Exeter, United Kingdom, EX2 5DW
Actively Recruiting
128
University College London Hospitals
London, United Kingdom, NW1 2PG
Actively Recruiting
129
Mount Vermont Cancer Center
Middlesex, United Kingdom, HA6 2RN
Actively Recruiting
130
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG5 1PB
Actively Recruiting
131
Singleton Hospital
Swansea, United Kingdom, SA2 8QA
Actively Recruiting
132
Royal Cornwall Hospital
Truro, United Kingdom, TR1 3LJ
Actively Recruiting
Research Team
B
BioNTech clinical trials patient information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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