Molecular Characterization and Clinical Implications of Endometrial Cancer.
Angeles Alvarez Secord, Matthew A Powell, Jessica McAlpine
https://pubmed.ncbi.nlm.nih.gov/40966692Actively Recruiting
Phase 3
Age: 18Years +
FEMALE
ID06340568
Phase III Trial of BNT323/DB-1303 Versus Chemotherapy in Previously Treated Patients With HER2-Expressing Recurrent Endometrial Cancer
Led by BioNTech SE · Updated on 2026-05-20
480
Participants Needed
156
Research Sites
87 weeks
Total Duration
On this page
Sponsors
B
BioNTech SE
Lead Sponsor
D
DualityBio Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effects of BNT323 (also known as DB-1303) compared with chemotherapy in women with recurrent endometrial cancer that expresses the HER2 protein. The study is divided into two groups based on HER2 levels in tumor samples. The first group includes participants with lower HER2 expression who have previously received immune checkpoint inhibitors, while the second group includes participants with higher HER2 expression receiving BNT323 alone. The study also monitors safety, immune response, and quality of life. Participants in the first group will be randomly assigned to receive either BNT323 or chemotherapy drugs such as doxorubicin, paclitaxel, or docetaxel, depending on what is suitable. The second group will receive BNT323 alone. Treatments are given until the disease progresses, unacceptable side effects occur, or participants choose to stop. The study includes screening, treatment, safety follow-up, efficacy follow-up, and a long-term survival follow-up lasting up to 53 months. During the study, participants will undergo regular assessments to measure how well the treatments control cancer progression or shrink tumors. Safety is closely monitored by tracking side effects and how the body processes BNT323. Researchers will also evaluate overall survival and quality of life. The expected treatment period is about six months, with long-term follow-up to observe survival outcomes over several years.
CONDITIONS
Brief Title
A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Female adults aged 18 years or older
- Histologically confirmed recurrent endometrial cancer
- HER2 IHC score of 1+ or 2+ (Cohort 1) or 3+ (Cohort 2) by central laboratory testing
- Measurable disease by RECIST v1.1 criteria
- ECOG Performance Status of 0, 1, or 2
- Recurrence within 12 months after platinum-based chemotherapy for Stage I to 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...
- Ineligible for all chemotherapy options in investigator's choice arm (Cohort 1 only)
- History of small bowel obstruction requiring hospitalization within 3 months before first study dose
- Uncontrolled intercurrent illness limiting study compliance or increasing risk of adverse events
- Clinically uncontrolled pleural, pericardial, or abdominal effusions requiring drainage within 2 weeks before first study dose
- History or current interstitial lung disease or pneumonitis requiring steroids
- Use of immunosuppressive medication within 14 days before first study dose (exceptions apply)
- Significant lung disease or prior complete lung removal
- Uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks before first study dose
- Unresolved toxicities from prior anti-cancer therapy above Grade 1 except controlled exceptions
- Pregnant, breastfeeding, or planning pregnancy during study and up to 7 months after last dose
- History of allergies or intolerance to study treatments or monoclonal antibodies (unless desensitized)
- Prior treatment with topoisomerase I inhibitors including ADCs
- Left ventricular ejection fraction below 55% or tissue doppler E/e' ratio >15 within 28 days before first study dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 6 months
Participants receive either BNT323/DB-1303 or investigator's choice of single agent chemotherapy until disease progression, unacceptable toxicity, or withdrawal of consent.
Regular visits during treatment as per protocol
Safety Follow-up
Duration - Up to 35 days after last dose
Participants are monitored for safety and adverse events after completing treatment.
1 to 2 visits depending on safety assessments
Efficacy Follow-up
Duration - Up to approximately 53 months
Participants are monitored to assess the effectiveness of the treatment over time.
Periodic visits for efficacy assessments
Long-term Survival Follow-up
Duration - Up to approximately 53 months
Participants are followed to monitor long-term survival outcomes after treatment.
Periodic visits or contacts for survival status
Trial Site Locations
Total: 156 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
NYU Langone Health
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
Sanford Cancer Center
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
8
Hospital Británico de Buenos Aires
Buenos Aires, Argentina, C1280AEB
Actively Recruiting
9
Investigaciones CORI S.R.L.
La Rioja, Argentina, F5300COE
Actively Recruiting
10
Hospital Provincial del Centenario
Rosario, Argentina, S2002KDS
Actively Recruiting
11
Centro Oncológico de Excelencia
San Juan, Argentina, 5400
Actively Recruiting
12
Adelaide Oncology & Haematology
Adelaide, Australia, 5000
Actively Recruiting
13
Cancer Research SA
Adelaide, Australia, 5000
Actively Recruiting
14
Monash Health Clinical Trial Center
Clayton, Australia, 3168
Actively Recruiting
15
Gosford Hospital
Gosford, Australia, 2250
Actively Recruiting
16
Peter MacCallum Cancer Centre
Melbourne, Australia, 3000
Actively Recruiting
17
Frankston Hospital
Melbourne, Australia, VIC 3199
Actively Recruiting
18
Shoalhaven Cancer Care Centre
Nowra, Australia, 2541
Actively Recruiting
19
Sunshine Hospital
Saint Albans, Australia, 3021
Actively Recruiting
20
Mater Hospital Brisbane
South Brisbane, Australia, 4001
Actively Recruiting
21
Wollongong Hospital
Wollongong, Australia, 2500
Actively Recruiting
22
Institut Jules Bordet
Brussels, Belgium, 1070
Actively Recruiting
23
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
24
AZ Groeninge VZW
Kortrijk, Belgium, 8500
Actively Recruiting
25
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
26
CHU UCL Namur-Sainte-Elisabeth
Namur, Belgium, B5000
Actively Recruiting
27
Fundação Sao Francisco Xavier
Ipatinga, Brazil, 35162-189
Actively Recruiting
28
Hospital de Clínicas de Passo Fundo
Passo Fundo, Brazil, 99010-260
Actively Recruiting
29
Instituto de Pesquisa Clínica - Hospital Moinhos de Vento
Porto Alegre, Brazil, 90035-000
Actively Recruiting
30
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil, 90035-903
Actively Recruiting
31
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil, 90050-170
Actively Recruiting
32
HPT São Lucas da PUCRS - UBEA
Porto Alegre, Brazil, 90610-000
Actively Recruiting
33
Fundação Faculdade Regional de Medicina de São José do Rio Petro
São José do Rio Preto, Brazil, 15090-000
Actively Recruiting
34
Hospital Sirio Libanês
São Paulo, Brazil, 01308-050
Actively Recruiting
35
Inst D'Or de Pesquisa E Ensino
São Paulo, Brazil, 01401-002
Actively Recruiting
36
Jewish General Hospital
Montreal, Canada, H3T 1E2
Actively Recruiting
37
Health Sciences Centre
St. John's, Canada, A1V 3V6
Actively Recruiting
38
Princess Margaret Cancer C
Toronto, Canada, M5G 2M9
Actively Recruiting
39
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
Actively Recruiting
40
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
41
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010
Actively Recruiting
42
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China, 350014
Actively Recruiting
43
First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
44
Gansu Provincial Maternity and Child-care Hospital
Lanzhou, Gansu, China, 730050
Actively Recruiting
45
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Actively Recruiting
46
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China, 515063
Actively Recruiting
47
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, China, 530200
Actively Recruiting
48
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150091
Actively Recruiting
49
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450014
Actively Recruiting
50
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Actively Recruiting
51
Xiangyang Central Hospital
Xiangyang, Hubei, China, 441138
Actively Recruiting
52
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Actively Recruiting
53
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China, 330006
Actively Recruiting
54
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
55
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
56
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250117
Actively Recruiting
57
Affiliated Hospital of Jining Medical University
Jining, Shandong, China, 272029
Actively Recruiting
58
Linyi Cancer Hospital
Linyi, Shandong, China, 276001
Actively Recruiting
59
Yantai Yuhuangding Hospital
Yantai, Shandong, China, 264000
Actively Recruiting
60
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
61
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
62
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Actively Recruiting
63
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
64
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
65
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325015
Actively Recruiting
66
Gynekologicko-porodnická klinika, Fakultni nemocnice Brno
Brno, Czechia, 60200
Actively Recruiting
67
University Hospital Olomouc - Onkologická klinika- Fakultni
Olomouc, Czechia, 77900
Actively Recruiting
68
Fakultní nemocnice Motol a Homolka
Prague, Czechia, 15000
Actively Recruiting
69
Fakultní nemocnice Bulovka
Prague, Czechia, 18081
Actively Recruiting
70
Aalborg Universit Hospital
Aalborg, Denmark, 9000
Actively Recruiting
71
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
72
Herlev og Gentofte Hospital
Herlev, Denmark, 2730
Actively Recruiting
73
Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
74
Kuopio University HPT
Kuopio, Finland, 70210
Actively Recruiting
75
OYS Naisten poliklinikka
Oulu, Finland, 90029
Actively Recruiting
76
ICO - Site Paul Papin
Angers, France, 49055
Actively Recruiting
77
CHU Besançon Service Oncologie
Besançon, France, 25000
Actively Recruiting
78
Centre François Baclesse
Caen, France, 14000
Actively Recruiting
79
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, France, 72000
Actively Recruiting
80
Hôpital Nord Bâtiment Mistral
Marseille, France, 13015
Actively Recruiting
81
Hôpital Saint Louis
Paris, France, 75010
Actively Recruiting
82
ICO - Site René Gauducheau
Saint-Herblain, France, 44800
Actively Recruiting
83
Institut de Cancérologie de Strasbourg Europe - ICANS
Strasbourg, France, 67000
Actively Recruiting
84
Alexandra General Hospital of Athens
Athens, Greece, 11528
Actively Recruiting
85
Aretaieio Hospital
Athens, Greece, 11528
Actively Recruiting
86
University General Hospital Attikon
Chaïdári, Greece, 124 62
Actively Recruiting
87
General Hospital of Kalamata
Kalamata, Greece, 24100
Actively Recruiting
88
IASO General Clinic
Marousi, Greece, 151 23
Actively Recruiting
89
Debreceni Egyetem
Debrecen, Hungary, 4032
Actively Recruiting
90
Bács-Kiskun Vármegyei Oktatókórház
Kecskemét, Hungary, 6000
Actively Recruiting
91
Lady Davis Carmel Medical Center
Haifa, Israel, 3436212
Actively Recruiting
92
Hadassah Ein Kerem Medical Center
Jerusalem, Israel, 9112001
Actively Recruiting
93
Rabin Medical Center-Beilinson Campus
Petah Tikva, Israel, 4941492
Actively Recruiting
94
Sheba Medical Center
Ramat Gan, Israel, 5265601
Actively Recruiting
95
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
Bari, Italy, 70124
Actively Recruiting
96
Azienda Ospedaliera Cannizzaro - Oncologia
Catania, Italy, 95126
Actively Recruiting
97
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST)
Meldola, Italy, 47014
Actively Recruiting
98
Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
99
Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
100
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
101
Humanitas San Pio X
Milan, Italy, 20159
Actively Recruiting
102
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Italy, 80131
Actively Recruiting
103
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
104
Azienda Ospedaliera Ordine Mauriziano Umberto I di Torino
Torino, Italy, 10128
Actively Recruiting
105
Radboud UMC
Nijmegen, Netherlands, 6525 GA
Actively Recruiting
106
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 AA
Actively Recruiting
107
Oslo University Hospital
Oslo, Norway, 0379
Actively Recruiting
108
Stavanger University Hospital
Stavanger, Norway, 4011
Actively Recruiting
109
Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie
Bialystok, Poland, 15-027
Actively Recruiting
110
Siedleckie Centrum Onkologii
Siedlce, Poland, 08-110
Actively Recruiting
111
Samsung Changwon Hospital
Changwon, South Korea, 51353
Actively Recruiting
112
Keimyung Univty Dongsan Hospital
Daegu, South Korea, 42601
Actively Recruiting
113
National Cancer Center
Goyang, South Korea, 10408
Actively Recruiting
114
Seoul National University Bundang Hospital
Seongnam, South Korea, 13620
Actively Recruiting
115
CHA Bundang Medical Center
Seongnam-si, South Korea, 13496
Actively Recruiting
116
Korea University Anam Hospital
Seoul, South Korea, 02841
Actively Recruiting
117
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
118
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
119
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
120
Gangnam Severance Hospital, Yonsei University Health System
Seoul, South Korea, 06273
Actively Recruiting
121
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
122
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea, 06591
Actively Recruiting
123
Ewha Womans University Seoul Hospital
Seoul, South Korea, 07804
Actively Recruiting
124
Hospital Universitari Vall, d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
125
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
126
Hospital Universitario Reina Sofia
Córdoba, Spain, 14004
Actively Recruiting
127
Institut Català d'Oncologia (ICO) Hospital Universitari de Girona Dr. Josep Trueta
Girona, Spain, 17007
Actively Recruiting
128
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
129
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
130
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
131
Instituto Valenciano de Oncología - Valencia
Valencia, Spain, 46009
Actively Recruiting
132
Skånes Universitetssjukhus Lund
Lund, Sweden, 222 42
Actively Recruiting
133
Karolinska University Hospital
Stockholm, Sweden, 17176
Actively Recruiting
134
China Medical University Hospital
Taichung, Taiwan, 40447
Actively Recruiting
135
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
136
Kuang Tien General Hospital
Taichung, Taiwan, 433004
Actively Recruiting
137
National Cheng Kung University Hospital
Tainan, Taiwan, 70457
Actively Recruiting
138
MacKay Memorial Hospital_ Taipei Branch
Taipei, Taiwan, 10449
Actively Recruiting
139
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
140
Baskent University Adana Application and Research Center
Adana, Turkey (Türkiye), 01120
Actively Recruiting
141
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
Ankara, Turkey (Türkiye), 06200
Actively Recruiting
142
Hacettepe University
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
143
Baskent University Ankara Hospital
Ankara, Turkey (Türkiye), 06490
Actively Recruiting
144
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
Istanbul, Turkey (Türkiye), 34093
Actively Recruiting
145
Royal Sussex County Hospital
Brighton, United Kingdom, BN2 1ES
Actively Recruiting
146
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Actively Recruiting
147
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
148
Castle Hill Hospital
Cottingham, United Kingdom, HU165JQ
Actively Recruiting
149
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Actively Recruiting
150
Royal Devon & Exeter HPT
Exeter, United Kingdom, EX2 5DW
Actively Recruiting
151
University College London Hospitals
London, United Kingdom, NW1 2PG
Actively Recruiting
152
Guy's Hospital
London, United Kingdom, SE1 9RT
Actively Recruiting
153
Mount Vermont Cancer Center
Middlesex, United Kingdom, HA6 2RN
Actively Recruiting
154
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG5 1PB
Actively Recruiting
155
Singleton Hospital
Swansea, United Kingdom, SA2 8QA
Actively Recruiting
156
Royal Cornwall Hospital
Truro, United Kingdom, TR1 3LJ
Actively Recruiting
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Research Team
B
BioNTech clinical trials patient information
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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