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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: 07 Sep 2026

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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

  • 26 Aug 2026 According to Alligator Biosciences Media Release, Alligator stated that it was exploring alternative routes to Phase 3 development of mitazalimab in first-line metastatic pancreatic cancer and had signed a letter of intent with the French non-profit cancer research organisation Unicancer to assess the feasibility of a global investigator-sponsored Phase 3 study. No development decisions had been taken.
  • 23 Jul 2026 According to Alligator Biosciences Media Release, the Company intends to discontinue all further independent development of, and Phase 3 trial preparation and support for, its lead candidate mitazalimab.
  • 01 Jul 2025 According to Alligator Biosciences Media Release, the positive clinical response data observed in OPTIMIZE-1 has favorable safety profile and supporting 900 mwg/kg as the recommended Phase 3 dose and this decision has been recently endorsed by the FDA.

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