BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors

Trial status:Recruitment Complete
Trial ID:
BNT151-01
NCT ID:
NCT04455620
EudraCT ID:
2019-003572-39
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
Recruitment Complete

Trial Details

This is an open-label, multicenter Phase I/IIa dose escalation, safety, pharmacokinetic (PK) and pharmacodynamic (PD) trial of BNT151 with expansion cohorts in various solid tumor indications. The trial consists of Part 1, Part 2A and Part 2B with adaptive design elements: The monotherapy dose escalation, (Part 1) of this clinical trial will enroll patients with various solid tumors that are metastatic or of advanced unresectable stage for whom there is no available standard therapy likely to confer clinical benefit, or patients who are not candidates for such available therapy. The Part 1 of the trial also plans to implement a dedicated biomarker cohort in BNT151 monotherapy: The Biomarker Cohort will recruit patients at selected sites in the US only. The objective of the cohort is to observe PD activity and drug-induced changes in the blood and tumor. During combination dose escalation (Part 2A), patients of different specific solid tumors (one cohort per indication) will be enrolled and treated with a combination of BNT151 and the respective standard of care (SoC) treatment. Part 2B is the expansion phase where a predefined number of patients in each indication cohort will be treated with the confirmed recommended phase II dose (RP2D) of BNT151 in combination with respective SoC.

Medical Condition
  • Solid Tumors
    • Trial Drug
  • BNT151
    • Phase
    Phase 1
    Type
    Interventional
    Estimated Enrolment
    84
    Estimated Trial Date
    Jan 2021 - May 2024

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No

    Trial Locations

    Location
    Status
    Location
    Yale Cancer Center
    New Haven, Connecticut, United States, 06510
    Status
    Location
    Sarah Cannon Research Institute at Tennessee Oncology
    Nashville, Tennessee, United States, 37203
    Status
    Location
    University of Texas MD Anderson Cancer Center
    Houston, Texas, United States, 77030
    Status
    Location
    NEXT Oncology
    San Antonio, Texas, United States, 78229
    Status
    Location
    Vall dĀ“Hebron Institute of Oncology (VHIO)
    Barcelona, Spain, 08035
    Status
    Location
    START Madrid - HM CIOCC
    Madrid, Spain, 28050
    Status