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RECRUITING

NCT06340568

PHASE3

A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer

Sponsor: BioNTech SE

View on ClinicalTrials.gov

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.

Official title: A Phase III, Randomized, Multi-site, Open-label Trial of BNT323/DB-1303 Versus Investigator's Choice of Chemotherapy in Previously Treated Patients With HER2- Expressing Recurrent Endometrial Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

480

Start Date

2025-06-10

Completion Date

2029-11

Last Updated

2026-03-31

Healthy Volunteers

Conditions

Endometrial Cancer

Interventions

DRUG

BNT323/DB-1303

intravenous (IV) infusion

DRUG

Doxorubicin

IV bolus or infusion

DRUG

Paclitaxel

IV infusion

DRUG

Docetaxel

IV infusion

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.

Locations (112)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Broward Health Medical Center

Fort Lauderdale, Florida, 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

Shoalhaven Cancer Care Centre

Nowra, Australia

Sunshine Hospital

Saint Albans, Australia

Mater Hospital Brisbane

South Brisbane, Australia

Wollongong Hospital

Wollongong, Australia

AZ Groeninge VZW

Kortrijk, Belgium

UZ Leuven

Leuven, Belgium

CHU UCL Namur-Sainte-Elisabeth

Namur, Belgium

Fundação Sao Francisco Xavier

Ipatinga, Brazil

Hospital de Clínicas de Passo Fundo

Passo Fundo, Brazil

Instituto de Pesquisa Clínica - Hospital Moinhos de Vento

Porto Alegre, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Brazil

HPT São Lucas da PUCRS - UBEA

Porto Alegre, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Petro

São José do Rio Preto, Brazil

Hospital Sirio Libanês

São Paulo, Brazil

Inst D'Or de Pesquisa E Ensino

São Paulo, 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

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

First Affiliated Hospital of Xiamen University

Xiamen, 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

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 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

Fakultní nemocnice Motol a Homolka

Prague, Czechia

Fakultní nemocnice Bulovka

Prague, Czechia

Aalborg Universit Hospital

Aalborg, Denmark

Rigshospitalet

Copenhagen, Denmark

Odense University Hospital

Odense, Denmark

Kuopio University HPT

Kuopio, Finland

OYS Naisten poliklinikka

Oulu, Finland

ICO - Site Paul Papin

Angers, France

CHU Besançon Service Oncologie

Besançon, France

Centre François Baclesse

Caen, France

Clinique Victor Hugo - Centre Jean Bernard

Le Mans, France

Hôpital Nord Bâtiment Mistral

Marseille, France

Hôpital Saint Louis

Paris, France

ICO - Site René Gauducheau

Saint-Herblain, France

Institut de Cancérologie de Strasbourg Europe - ICANS

Strasbourg, France

Lady Davis Carmel Medical Center

Haifa, Israel

Hadassah Ein Kerem Medical Center

Jerusalem, Israel

Sheba Medical Center

Ramat Gan, Israel

Azienda Ospedaliera Cannizzaro - Oncologia

Catania, Italy

IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST)

Meldola, Italy

Istituto Europeo di Oncologia

Milan, Italy

Azienda Ospedaliera Ordine Mauriziano Umberto I di Torino

Torino, Italy

Radboud UMC

Nijmegen, Netherlands

Samsung Changwon Hospital

Changwon, South Korea

Keimyung Univty Dongsan Hospital

Daegu, South Korea

National Cancer Center

Goyang, South Korea

Seoul National University Bundang Hospital

Seongnam, South Korea

CHA Bundang Medical Center

Seongnam-si, 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

Karolinska University Hospital

Stockholm, Sweden

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

Clinical Research Directory

A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (112)