Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors

Trial status:Recruiting
Trial ID:
BNT317-01
NCT ID:
NCT06750185
EudraCT ID:
N/A
EU Trial (CTIS) Number:
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 first-in-human (FIH), open-label, multiple-site, dose escalation study which will evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of increasing doses of BNT317 in participants with advanced solid tumors.

Medical Condition
  • Solid Tumors
    • Trial Drug
  • BNT317 DL1
    • See more
  • BNT317 DL2
  • BNT317 DL3
  • BNT317 DL4
  • BNT317 DL5 (intermediate)
  • BNT317 DL6 (intermediate)
  • BNT317 DL7 (additional)
    • Phase
    Phase 1
    Type
    Interventional
    Estimated Enrolment
    39
    Estimated Trial Date
    Jan 2025 - Jun 2028

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No

    Trial Locations

    Location
    Status
    Location
    Norton Cancer Institute PARENT
    Louisville, Kentucky, United States, 40202
    Status
    Recruiting
    Location
    START Midwest
    Grand Rapids, Michigan, United States, 49546
    Status
    Recruiting
    Location
    Carolina BioOncology Institute, LLC
    Huntersville, North Carolina, United States, 28078
    Status
    Recruiting
    Location
    Rhode Island Hospital
    East Providence, Rhode Island, United States, 02903
    Status
    Recruiting
    Location
    Mary Crowley Cancer Research
    Dallas, Texas, United States, 75230
    Status
    Recruiting
    Location
    South Texas Accelerated Research Therapeutics (START), LLC
    San Antonio, Texas, United States, 78229
    Status
    Recruiting
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