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
EU Trial (CTIS) Number:
2024-517979-20-00
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-positive, HER2-low (immunohistochemistry \[IHC\] 1+ or IHC 2+/in situ hybridization -), HER2-ultralow (IHC 0, with membrane staining) or HER2-null breast cancer (BC), or triple-negative breast cancer (TNBC).

Medical Condition
  • Breast Cancer
  • Unmapped
    • Trial Drug
  • BNT323
    • See more
  • BNT327
    • Phase
    Phase 1/Phase 2
    Type
    Interventional
    Estimated Enrolment
    380
    Estimated Trial Date
    Apr 2025 - May 2028

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No
    Inclusion and Exclusion Criteria
    Exclusion criteria

      Key Inclusion Criteria (applicable to all participants and all parts unless otherwise specified):

    • Have pathologically documented BC that:
      • Is locally advanced, unresectable or metastatic.
      • Has a confirmed HER2 status as determined by the local laboratory (Part 1, Part 2 Cohorts 2 and 4) or the central laboratory (Part 2, Cohorts 1 and 3) from the most recently collected pre-randomization tumor sample.
      • Has a documented history of HER2 expression consistent with the subgroup definitions (i.e., HER2-low, HER2-ultralow, HER2-null, HER2-positive, or TNBC) as per current American Society of Clinical Oncology/College of American Pathologists guidelines.
    • Have measurable disease defined by RECIST v1.1.
    • Has left ventricular ejection fraction ≥55% by either echocardiography or multi-gated acquisition (scanning) within 28 days before randomization/enrollment.
    • Have history of small bowel obstruction requiring hospitalization within the past 3 months prior to the first dose of IMP.
    • Have an uncontrolled intercurrent illness that would limit compliance with study requirement or substantially increase risk of incurring adverse events.
    • Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to randomization/enrollment.
    • Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
    • Had prior treatment with topoisomerase I inhibitors, including ADCs with topoisomerase I inhibitor payloads such as trastuzumab deruxtecan.
    • Have received any of the following therapies or drugs prior to the initiation of the study:
      • Participants who have previously been randomized to or received treatment in a previous study with BNT323, regardless of treatment assignment.
      • Participants who received prior treatment with a PD-L1/VEGF bispecific antibody. Note: Prior treatment with PD-1/VEGF bispecific antibodies, PD-1/PD-L1 inhibitors or anti-VEGF therapies are permitted.
      • Have received other systemic immunostimulatory agents or immunosuppressive therapies (such as interferon-α, interleukin-2, or methotrexate) within 4 weeks prior to the initiation of study treatment or are within five half-lives of the treatment drug (whichever is longer). Exception: excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens).
      • Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 3 weeks prior to the initiation of study treatment.

      • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

    Trial Locations

    Location
    Status
    Location
    Hematology - Oncology Associates of the Treasure Coast
    Port Saint Lucie, Florida, United States, 34952
    Status
    Recruiting
    Location
    START Midwest, LLC
    Grand Rapids, Michigan, United States, 49546
    Status
    Recruiting
    Location
    South Texas Accelerated Research Therapeutics (START), LLC
    San Antonio, Texas, United States, 78229
    Status
    Recruiting
    Location
    Sichuan Cancer Hospital
    Chengdu, China, 610072
    Status
    Recruiting
    Location
    Huizhou First Hospital
    Huizhou, China, 516003
    Status
    Recruiting
    Location
    Fudan University Shanghai Cancer
    Shanghai, China, 201315
    Status
    Recruiting
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