A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer

Trial status:Recruiting
Trial ID:
BNT323-03
NCT ID:
NCT06827236
EudraCT ID:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Recruiting

Trial Details

This is a Phase I/II, multi-site, open-label, two-part study designed to evaluate the efficacy, safety, optimized dose and contribution of components of BNT323 in combination with BNT327 in participants with hormone receptor-positive (HR+) or hormone receptor-negative (HR-), Human epidermal growth factor receptor (HER)2-low (immunohistochemistry \[IHC\] 1+ or IHC 2+/in situ hybridization -), HER2-ultralow (IHC 0, with membrane staining), or HER2-null breast cancer (BC).

Medical Condition
  • Breast Cancer
    • Trial Drug
  • BNT323
    • See more
  • BNT327
    • Phase
    Phase 1/Phase 2
    Type
    Interventional
    Estimated Enrolment
    320
    Estimated Trial Date
    Apr 2025 - Mar 2028

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No

    Trial Locations

    Location
    Status
    Location
    Hematology - Oncology Associates of the Treasure Coast
    Port Saint Lucie, Florida, United States, 34952
    Status
    Recruiting
    Location
    Institute of Oncology Arensia Exploratory Medicine
    Chisinau, Republic of Moldova, 2025
    Status
    Recruiting