Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy

Trial status:Recruiting
Trial ID:
BNT327-02
NCT ID:
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 study is a Phase II, multi-site, randomized, open-label clinical study to evaluate the safety, efficacy, and pharmacokinetics (PK) of BNT327 at two dose levels in combination with chemotherapeutic agents in the first- and second-line treatment of participants with locally advanced/metastatic triple-negative breast cancer (mTNBC).

Medical Condition
  • Breast Cancer
  • Trial Drug
  • BNT327 Dose Level 1 (DL1)
  • See more
  • BNT327 Dose Level 1 (DL2)
  • BNT327 Optimized Dose
  • BNT327 Equivalent Q3W Dose
  • Nab-placlitaxel
  • Carboplatin
  • Gemcitabine
  • Paclitaxel
  • Eribulin
  • Phase
    Phase 2
    Type
    Interventional
    Estimated Enrolment
    70
    Estimated Trial Date
    Aug 2024 - Mar 2025

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No

    Trial Locations

    Location
    Status
    Location
    Arizona Oncology Associates, PC
    Tucson, Arizona, United States, 85711
    Status
    Recruiting
    Location
    Beverly Hills Cancer Center
    Beverly Hills, California, United States, 90211
    Status
    Recruiting
    Location
    Valkyrie Clinical Trials
    Los Angeles, California, United States, 90067
    Status
    Recruiting
    Location
    Saint John's Health Center - John Wayne Cancer Institute (JWCI)
    Santa Monica, California, United States, 90404-2312
    Status
    Recruiting
    Location
    Rocky Mountain Cancer Centers (RMCC)
    Denver, Colorado, United States, 80220
    Status
    Recruiting
    Location
    Yale University - Yale Cancer Center
    New Haven, Connecticut, United States, 06520
    Status
    Recruiting