A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer
NCT ID: NCT06340568
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
480 participants
INTERVENTIONAL
2025-06-10
2029-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1 (HER2 IHC score 1+ or 2+): BNT323/DB-1303
BNT323/DB-1303
intravenous (IV) infusion
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).
Doxorubicin
IV bolus or infusion
Paclitaxel
IV infusion
Docetaxel
IV infusion
Cohort 2 (HER2 IHC score 3+) - BNT323/DB-1303
BNT323/DB-1303
intravenous (IV) infusion
Interventions
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BNT323/DB-1303
intravenous (IV) infusion
Doxorubicin
IV bolus or infusion
Paclitaxel
IV infusion
Docetaxel
IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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DualityBio Inc.
INDUSTRY
BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
UNKNOWN
BioNTech SE
INDUSTRY
Responsible Party
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Principal Investigators
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BioNTech Responsible Person
Role: STUDY_DIRECTOR
BioNTech SE
Locations
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MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
The Center of Hope Reno
Reno, Nevada, United States
Miami Valley Hospital South
Centerville, Ohio, United States
Hospital Británico de Buenos Aires
Buenos Aires, , Argentina
Investigaciones CORI S.R.L.
La Rioja, , Argentina
Hospital Provincial del Centenario
Rosario, , Argentina
Centro Oncológico de Excelencia
San Juan, , Argentina
Adelaide Oncology & Haematology
Adelaide, , Australia
Cancer Research SA
Adelaide, , Australia
Gosford Hospital
Gosford, , Australia
Frankston Hospital
Melbourne, , Australia
Sunshine Hospital
Saint Albans, , Australia
Mater Hospital Brisbane
South Brisbane, , Australia
Wollongong Hospital
Wollongong, , Australia
UZ Leuven
Leuven, , Belgium
CHU UCL Namur-Sainte-Elisabeth
Namur, , Belgium
Hospital de Clínicas de Passo Fundo
Passo Fundo, , Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, , Brazil
Jewish General Hospital
Montreal, , Canada
Health Sciences Centre
St. John's, , Canada
Princess Margaret Cancer C
Toronto, , Canada
Anhui Provincial Hospital
Hefei, Anhui, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Gansu Provincial Maternity and Child-care Hospital
Lanzhou, Gansu, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Beijing Cancer Hospital
Beijing, , China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, , China
Aalborg Universit Hospital
Aalborg, , Denmark
Rigshospitalet
Copenhagen, , Denmark
ICO - Site Paul Papin
Angers, , France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, , France
Institut de Cancérologie de Strasbourg Europe - ICANS
Strasbourg, , France
Radboud UMC
Nijmegen, , Netherlands
Keimyung Univty Dongsan Hospital
Daegu, , South Korea
National Cancer Center
Goyang, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Ewha Womans University Seoul Hospital
Seoul, , South Korea
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Kuang Tien General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
MacKay Memorial Hospital_ Taipei Branch
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Royal Sussex County Hospital
Brighton, , United Kingdom
Bristol Haematology and Oncology Centre
Bristol, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
Castle Hill Hospital
Cottingham, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Royal Devon & Exeter HPT
Exeter, , United Kingdom
University College London Hospitals
London, , United Kingdom
Mount Vermont Cancer Center
Middlesex, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Singleton Hospital
Swansea, , United Kingdom
Royal Cornwall Hospital
Truro, , United Kingdom
Countries
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Central Contacts
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References
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Secord AA, Powell MA, McAlpine J. Molecular Characterization and Clinical Implications of Endometrial Cancer. Obstet Gynecol. 2025 Nov 1;146(5):660-671. doi: 10.1097/AOG.0000000000006080. Epub 2025 Sep 18.
Other Identifiers
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GOG-3105
Identifier Type: OTHER
Identifier Source: secondary_id
2023-507525-42-00
Identifier Type: CTIS
Identifier Source: secondary_id
ENGOT- EN25/NSGO-CTU
Identifier Type: OTHER
Identifier Source: secondary_id
BNT323-01
Identifier Type: -
Identifier Source: org_study_id
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