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

Trial status:Recruiting
Study Identifier:
BNT327-02
ClinicalTrials.gov Identifier:
NCT06449222
EudraCT Identifier:
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

Medical Condition
  • Breast Cancer
    • Study Drug
  • Drug: BNT327 Dose Level 1 (DL1)
  • Drug: BNT327 Dose Level 1 (DL2)
  • Drug: Taxane A
    • See more
  • Drug: Alkylating agent
  • Drug: Antimetabolite
  • Drug: Taxane B
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+
    Estimated Trial Date
    Aug 2024 - Mar 2025

    Protocol summary

    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).

    Trial locations

    Location
    Status
    Location
    Beverly Hills Cancer Center
    Beverly Hills, California, United States, 90211
    Status
    Not yet recruiting
    Location
    Valkyrie Clinical Trials
    Los Angeles, California, United States, 90067
    Status
    Recruiting
    Location
    Orchard Healthcare Research Inc.
    Skokie, Illinois, United States, 60077
    Status
    Recruiting
    Location
    Helen G. Nassif Community Cancer Center
    Cedar Rapids, Iowa, United States, 52403
    Status
    Not yet recruiting
    Location
    HealthPartners Frauenshuh Cancer Center
    Saint Louis Park, Minnesota, United States, 55426
    Status
    Not yet recruiting
    Location
    Clinical Research Alliance Inc.
    Westbury, New York, United States, 11590
    Status
    Recruiting