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A global phase 3 registrational study of Mitazalimab for the treatment of Pancreatic cancer

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Trial Profile

A global phase 3 registrational study of Mitazalimab for the treatment of Pancreatic cancer

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 28 Jun 2025

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At a glance

  • Drugs Mitazalimab (Primary) ; Fluorouracil; Folinic acid; Irinotecan; Oxaliplatin
  • Indications Pancreatic cancer
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 13 Jun 2025 According to an Alligator Bioscience media release, the U.S. Food and Drug Administration (FDA) has provided feedback supporting the selection of the 900 µg/kg dose of its CD40 agonist mitazalimab for the planned Phase 3 study in metastatic pancreatic ductal adenocarcinoma (mPDAC).
  • 06 Feb 2025 According to an Alligator Bioscience media release, the company announced successful end of phase 2 meeting with the FDA provided positive feedback and alignment on the non-clinical and clinical data packages to support the Biologics License Application (BLA), including the Phase 3 trial design, thus reinforcing earlier regulatory guidance from the Paul Ehrlich Institute (PEI) of Germany in July 2024. FDA feedback confirms that the toxicology package is adequate for the BLA submission.
  • 17 Jan 2025 According to an Alligator Bioscience media release, the company is on track for initiation of Phase 3 clinical activities during 2025.

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