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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: BioNTech SE • ClinicalTrials.gov ID: NCT06340568

Registry updated: 2026-10-16
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Description

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.

Interventions

  • BNT323/DB-1303 (Drug)
    intravenous (IV) infusion
  • Doxorubicin (Drug)
    IV bolus or infusion
  • Paclitaxel (Drug)
    IV infusion
  • Docetaxel (Drug)
    IV infusion

Eligibility criteria

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.

Conditions

Endometrial Cancer

Locations

  • USC/Norris Cancer Center — Los Angeles, California, United States
  • University of Colorado Cancer Center — Aurora, Colorado, United States
  • Yale University School of Medicine — New Haven, Connecticut, United States
  • MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
  • Broward Health Medical Center — Fort Lauderdale, Florida, United States
  • OSF Saint Francis Medical Center — Peoria, Illinois, United States
  • Carle Cancer Institute — Urbana, Illinois, United States
  • Baptist Health Lexington — Lexington, Kentucky, United States
  • WK Cancer Center — Shreveport, Louisiana, United States
  • Minnesota Oncology — Minneapolis, Minnesota, United States
  • The Center of Hope Reno — Reno, Nevada, United States
  • NYU Langone Hospital - Long Island — Mineola, New York, United States
  • NYU Langone Health — New York, New York, United States
  • SUNY Upstate Medical University — Syracuse, New York, United States
  • Miami Valley Hospital South — Centerville, Ohio, United States
  • Ohio State University — Hilliard, Ohio, United States
  • Peggy & Charles Stephenson Oklahoma Cancer Center — Oklahoma City, Oklahoma, United States
  • Asplundh Cancer Pavilion — Willow Grove, Pennsylvania, United States
  • Sanford Cancer Center — Sioux Falls, South Dakota, United States
  • Texas Oncology, P.A. — Tyler, Texas, United States
  • Intermountain Healthcare — Murray, Utah, United States
  • Virginia Oncology Associates — Norfolk, Virginia, United States
  • Centro de Oncologia Dr. Doreski - Fundación Respirar — Buenos Aires, Argentina
  • Centro de Investigaciones Medicas Mar del Plata — Buenos Aires, Argentina
  • Hospital Británico de Buenos Aires — Buenos Aires, Argentina
  • CEMAIC - Centro Medico Privado — Córdoba, Argentina
  • Investigaciones CORI S.R.L. — La Rioja, Argentina
  • Fundación Oncológica Mendoza — Mendoza, Argentina
  • Hospital Provincial del Centenario — Rosario, Argentina
  • Centro Oncológico de Excelencia — San Juan, Argentina
  • Clinica Mayo de Urgencias — San Miguel de Tucumán, Argentina
  • Adelaide Oncology & Haematology — Adelaide, Australia
  • Cancer Research SA — Adelaide, Australia
  • Monash Health Clinical Trial Center — Clayton, Australia
  • Gosford Hospital — Gosford, Australia
  • Peter MacCallum Cancer Centre — Melbourne, 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
  • Medical University of Vienna — Vienna, Austria
  • Institut Jules Bordet — Brussels, Belgium
  • Cliniques Universitaires Saint-Luc — Brussels, Belgium
  • Universitair Ziekenhuis Antwerpen (UZA) — Edegem, Belgium
  • Universitair Ziekenhuis Gent — Ghent, Belgium
  • AZ Groeninge VZW — Kortrijk, Belgium
  • UZ Leuven — Leuven, Belgium
  • Centre Hospitalier Universitaire de Liège — Liège, 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
  • Union Hospital — Wuhan, China
  • Gynekologicko-porodnická klinika, Fakultni nemocnice Brno — Brno, Czechia
  • University Hospital Olomouc - Onkologická klinika- Fakultni — Olomouc, Czechia
  • Fakultní nemocnice Ostrava — Ostrava, Czechia
  • Vseobecna fakultni nemocnice v Praze — Prague, Czechia
  • Fakultní nemocnice Motol a Homolka — Prague, Czechia
  • Fakultní nemocnice Bulovka — Prague, Czechia
  • Aalborg Universit Hospital — Aalborg, Denmark
  • Rigshospitalet — Copenhagen, Denmark
  • Herlev og Gentofte Hospital — Herlev, Denmark
  • Odense University Hospital — Odense, Denmark
  • Kuopio University HPT — Kuopio, Finland
  • OYS Naisten poliklinikka — Oulu, Finland
  • Turun yliopistollinen keskussairaala — Turku, 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
  • Charité - Campus Virchow-Klinikum — Berlin, Germany
  • Kliniken Essen-Mitte — Essen, Germany
  • Klinkum Kassel — Kassel, Germany
  • LMU-Campus Innenstadt — München, Germany
  • Universitaets-Frauenklinik, Tübingen — Tübingen, Germany
  • Alexandra General Hospital of Athens — Athens, Greece
  • Aretaieio Hospital — Athens, Greece
  • University General Hospital Attikon — Chaïdári, Greece
  • General Hospital of Kalamata — Kalamata, Greece
  • IASO General Clinic — Marousi, Greece
  • Semmelweis Egyetem — Budapest, Hungary
  • Országos Onkológiai Intézet — Budapest, Hungary
  • Debreceni Egyetem — Debrecen, Hungary
  • Bács-Kiskun Vármegyei Oktatókórház — Kecskemét, Hungary
  • Zala Varmegyei Szent Rafael Korhaz — Zalaegerszeg, Hungary
  • Hillel Yaffe Medical Center — Hadera, Israel
  • Lady Davis Carmel Medical Center — Haifa, Israel
  • Shaare Zedek Medical Center — Jerusalem, Israel
  • Shaare Zedek — Jerusalem, Israel
  • Hadassah Ein Kerem Medical Center — Jerusalem, Israel
  • Rabin Medical Center-Beilinson Campus — Petah Tikva, Israel
  • Sheba Medical Center — Ramat Gan, Israel
  • Sourasky Medical Centre — Tel Aviv, Israel
  • Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari — Bari, Italy
  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS — Bologna, Italy
  • Azienda Ospedaliera Cannizzaro - Oncologia — Catania, Italy
  • IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) — Meldola, Italy
  • Ospedale San Raffaele — Milan, Italy
  • Istituto Nazionale dei Tumori — Milan, Italy
  • Istituto Europeo di Oncologia — Milan, Italy
  • Humanitas San Pio X — Milan, Italy
  • Istituto Nazionale Tumori Fondazione G. Pascale — Naples, Italy
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy
  • Azienda Ospedaliera Ordine Mauriziano Umberto I di Torino — Torino, Italy
  • Radboud UMC — Nijmegen, Netherlands
  • Erasmus Medisch Centrum — Rotterdam, Netherlands
  • Oslo University Hospital — Oslo, Norway
  • Stavanger University Hospital — Stavanger, Norway
  • Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie — Bialystok, Poland
  • Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan, Poland
  • Siedleckie Centrum Onkologii — Siedlce, Poland
  • National Cancer Centre Singapore — Singapore, Singapore
  • OncoCare Cancer Centre — Singapore, Singapore
  • 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
  • Hospital Universitari Vall, d'Hebron — Barcelona, Spain
  • Hospital Clinic de Barcelona — Barcelona, Spain
  • Hospital Universitario Reina Sofia — Córdoba, Spain
  • Hospital Universitar Donostia — Donostia / San Sebastian, Spain
  • Institut Català d'Oncologia (ICO) Hospital Universitari de Girona Dr. Josep Trueta — Girona, Spain
  • Hospital Universitario Ramón y Cajal — Madrid, Spain
  • Hospital Universitario 12 de Octubre — Madrid, Spain
  • Hospital Universitario La Paz — Madrid, Spain
  • Hospital Universit Son Espases — Palma de Mallorca, Spain
  • Instituto Valenciano de Oncología - Valencia — Valencia, Spain
  • Skånes Universitetssjukhus Lund — Lund, Sweden
  • Karolinska University Hospital — Stockholm, Sweden
  • Akademiska Sjukhuset — Uppsala, 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
  • Baskent University Adana Application and Research Center — Adana, Turkey (Türkiye)
  • Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital — Ankara, Turkey (Türkiye)
  • Hacettepe University — Ankara, Turkey (Türkiye)
  • Baskent University Ankara Hospital — Ankara, Turkey (Türkiye)
  • İzmir City Hospital — Bayraklı, Turkey (Türkiye)
  • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi — Istanbul, Turkey (Türkiye)
  • Istanbul University Istanbul Medical Faculty — Istanbul, Turkey (Türkiye)
  • 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
  • Warwick Hospital — Coventry, United Kingdom
  • Western General Hospital — Edinburgh, United Kingdom
  • Royal Devon & Exeter HPT — Exeter, United Kingdom
  • University College London Hospitals — London, United Kingdom
  • Guy's Hospital — 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record