A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer
Recruiting now · Phase 3
Conditions studied: Endometrial Cancer
In brief
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.
Key facts
- Study ID
- NCT06340568
- Run by
- BioNTech SE
- People needed
- 480
- Starts
- 2025-06-10
- Expected to finish
- 2029-11-01
- Last updated by the study team
- 2026-07-21
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
Where it is running
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
- Broward Health Medical Center — Fort Lauderdale, Florida, United States (enrolling)
- OSF Saint Francis Medical Center — Peoria, Illinois, United States (enrolling)
- The Center of Hope Reno — Reno, Nevada, United States (enrolling)
- NYU Langone Hospital - Long Island — Mineola, New York, United States (enrolling)
- NYU Langone Health — New York, New York, United States (enrolling)
- Miami Valley Hospital South — Centerville, Ohio, United States (enrolling)
- Ohio State University — Hilliard, Ohio, United States (enrolling)
- Sanford Cancer Center — Sioux Falls, South Dakota, United States (enrolling)
- Hospital Británico de Buenos Aires — Buenos Aires, Argentina (enrolling)
- Investigaciones CORI S.R.L. — La Rioja, Argentina (enrolling)
- Hospital Provincial del Centenario — Rosario, Argentina (enrolling)
- Centro Oncológico de Excelencia — San Juan, Argentina (enrolling)
- Adelaide Oncology & Haematology — Adelaide, Australia (enrolling)
- Cancer Research SA — Adelaide, Australia (enrolling)
- Monash Health Clinical Trial Center — Clayton, Australia (enrolling)
- Gosford Hospital — Gosford, Australia (enrolling)
- Peter MacCallum Cancer Centre — Melbourne, Australia (enrolling)
- Frankston Hospital — Melbourne, Australia (enrolling)
- Shoalhaven Cancer Care Centre — Nowra, Australia (enrolling)
- Sunshine Hospital — Saint Albans, Australia (enrolling)
- Mater Hospital Brisbane — South Brisbane, Australia (enrolling)
- Wollongong Hospital — Wollongong, Australia (enrolling)
- Institut Jules Bordet — Brussels, Belgium (enrolling)
- Yale University School of Medicine — New Haven, Connecticut, United States (enrolling)
Full record on ClinicalTrials.gov
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