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Clinical Trials in the USA / NCT06340568
Recruiting Phase 3

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

NCT06340568 · tracked via the Priya Life Science USA tracker
Sponsor
BioNTech SE
Phase
Phase 3
Started
2025-06-10
Last updated
2026-09-17

Condition(s) studied

Endometrial Cancer

Investigational drug(s) / intervention(s)

BNT323/DB-1303DoxorubicinPaclitaxelDocetaxel

BNT323/DB-1303: intravenous (IV) infusion

Doxorubicin: IV bolus or infusion

Paclitaxel: IV infusion

Docetaxel: IV infusion

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (191)

FacilityCityRegionStatus
Yale University School of Medicine New Haven Connecticut Recruiting
MedStar Washington Hospital Center Washington D.C. District of Columbia Recruiting
Broward Health Medical Center Fort Lauderdale Florida Recruiting
OSF Saint Francis Medical Center Peoria Illinois Recruiting
Carle Cancer Institute Urbana Illinois Recruiting
WK Cancer Center Shreveport Louisiana Recruiting
The Center of Hope Reno Reno Nevada Recruiting
NYU Langone Hospital - Long Island Mineola New York Recruiting
NYU Langone Health New York New York Recruiting
SUNY Upstate Medical University Syracuse New York Recruiting
Miami Valley Hospital South Centerville Ohio Recruiting
Ohio State University Hilliard Ohio Recruiting
Peggy & Charles Stephenson Oklahoma Cancer Center Oklahoma City Oklahoma Recruiting
Sanford Cancer Center Sioux Falls South Dakota Recruiting
Texas Oncology, P.A. Tyler Texas Recruiting
Intermountain Healthcare Murray Utah Recruiting
Centro de Oncologia Dr. Doreski - Fundación Respirar Buenos Aires Argentina Recruiting
Centro de Investigaciones Medicas Mar del Plata Buenos Aires Argentina Recruiting
Hospital Británico de Buenos Aires Buenos Aires Argentina Recruiting
Investigaciones CORI S.R.L. La Rioja Argentina Recruiting
Hospital Provincial del Centenario Rosario Argentina Recruiting
Centro Oncológico de Excelencia San Juan Argentina Recruiting
Adelaide Oncology & Haematology Adelaide Australia Recruiting
Cancer Research SA Adelaide Australia Recruiting
Monash Health Clinical Trial Center Clayton Australia Recruiting
Gosford Hospital Gosford Australia Recruiting
Peter MacCallum Cancer Centre Melbourne Australia Recruiting
Frankston Hospital Melbourne Australia Recruiting
Shoalhaven Cancer Care Centre Nowra Australia Recruiting
Sunshine Hospital Saint Albans Australia Recruiting
Mater Hospital Brisbane South Brisbane Australia Recruiting
Wollongong Hospital Wollongong Australia Recruiting
Institut Jules Bordet Brussels Belgium Recruiting
Cliniques Universitaires Saint-Luc Brussels Belgium Recruiting
Universitair Ziekenhuis Antwerpen (UZA) Edegem Belgium Recruiting
Universitair Ziekenhuis Gent Ghent Belgium Recruiting
AZ Groeninge VZW Kortrijk Belgium Recruiting
UZ Leuven Leuven Belgium Recruiting
CHU UCL Namur-Sainte-Elisabeth Namur Belgium Recruiting
Fundação Sao Francisco Xavier Ipatinga Brazil Recruiting

+ 151 more sites — see the full list on the official registry below.

More BioNTech SE trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06340568 on ClinicalTrials.gov ↗ ← All trials in the USA