Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma

Trial status:Recruiting
Trial ID:
BNT321-02
NCT ID:
NCT06069778
EudraCT ID:
2023-506014-47
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 trial is designed as a Phase I/randomized Phase II open-label trial of modified(m) FOLFIRINOX ± BNT321 for adjuvant therapy in pancreatic ductal adenocarcinoma (PDAC) patients post R0 or R1 resection. The Phase I, dose escalation part of this trial will be a limited evaluation of two planned BNT321 dose levels in combination with mFOLFIRINOX chemotherapy (24 weeks) followed by BNT321 monotherapy (24 weeks). Following determination of the combination recommended Phase II dose (RP2D), the Phase II (randomized treatment) part of this trial will be initiated as an open-label 2-arm evaluation of mFOLFIRINOX ± BNT321 (24 weeks) followed by BNT321 monotherapy (24 weeks) in the combination arm only to complete the adjuvant therapy course. Treatment cycles are every 2 weeks (14 days).

Medical Condition
  • Pancreatic Cancer
    • Trial Drug
  • BNT321 Dose Level 1
    • See more
  • BNT321 Dose Level 2
  • BNT321 RP2D
  • mFOLFIRINOX
    • Phase
    Phase 1/Phase 2
    Type
    Interventional
    Estimated Enrolment
    320
    Estimated Trial Date
    Mar 2024 - Apr 2029

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No

    Trial Locations

    Location
    Status
    Location
    Valkyrie Clinical Trials
    Los Angeles, California, United States, 90067
    Status
    Recruiting
    Location
    Clinical Research Alliance
    Westbury, New York, United States, 11590
    Status
    Recruiting
    Location
    Prisma Health Cancer Institute
    Greenville, South Carolina, United States, 29605
    Status
    Recruiting