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

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 determin

Trial Details

NCT ID
NCT06340568
Phase
PHASE3
Sponsor
BioNTech SE
Status
RECRUITING
Cancer Type
Uterine Cancer
Interventions
  • BNT323/DB-1303
  • Doxorubicin
  • Paclitaxel
  • Docetaxel
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Aurora, Colorado, United States|39.72943,-104.83192
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • Fort Lauderdale, Florida, United States|26.12231,-80.14338

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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