Safety and Preliminary Efficacy of BNT314 with or Without an Immune Checkpoint Inhibitor in Cancer Patients with Malignant Solid Tumors

Trial status:Recruiting
Trial ID:
BNT314-01
NCT ID:
NCT06150183
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

The purpose of this first-in-human study is to find out if BNT314 is safe when it is used alone and when it is used together with another antibody cancer drug (pembrolizumab) in patients with different types of cancer. Patients will receive either BNT314 alone or BNT314 combined with pembrolizumab. Phase 1 of the study consists of a dose escalation part, and a safety run-in (SRI) and expansion part: Dose escalation: In this part of the study, patients will be assigned to multiple dose levels (DLs) of BNT314 given alone. By escalating the dose with a small group of patients, the Maximum Tolerated Dose (MTD) which is the highest dose with acceptable safety and manageable side effects, or the maximum administered dose (MAD) will be investigated. At the end of this part, the Recommended Phase 2 Dose (RP2D) which is the dose to be tested in Phase 2 will be decided. Safety Run-In: In this part of the study, BNT314 will be combined with pembrolizumab. Before starting the expansion part, the combination will be tested in another small group of participants (12-28) to find out how safe this combination is. Expansion: In this part of the study, BNT314 will be combined with pembrolizumab. After the SRI is completed, the study will continue with the expansion part where up to 199 participants with different types of cancer will be included. The Phase 2 part of the study will be introduced via an amendment to the study protocol.

Medical Condition
  • Solid Tumors
    • Trial Drug
  • BNT314
    • See more
  • Pembrolizumab
    • Phase
    Phase 1/Phase 2
    Type
    Interventional
    Estimated Enrolment
    360
    Estimated Trial Date
    Nov 2023 - Jul 2027

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No

    Trial Locations

    Location
    Status
    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
    Cleveland Clinic
    Cleveland, Ohio, United States, 44195
    Status
    Recruiting
    Location
    GZA Ziekenhuizen
    Antwerpen, Belgium, 2018
    Status
    Recruiting
    Location
    CHU de Liège
    Liege, Belgium, 4000
    Status
    Recruiting
    Location
    Rigshospitalet
    Copenhagen, Denmark, DK-2100
    Status
    Recruiting