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The open-label, multi-center study aims to assess the safety and efficacy of an immunotherapeutic combination of mitazalimab (CD40 mAb) and a PD-1 inhibitor, in adult patients with histologically confirmed urothelial carcinoma, and who have progressed following prior treatment with PD-(L)1 therapy

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Trial Profile

The open-label, multi-center study aims to assess the safety and efficacy of an immunotherapeutic combination of mitazalimab (CD40 mAb) and a PD-1 inhibitor, in adult patients with histologically confirmed urothelial carcinoma, and who have progressed following prior treatment with PD-(L)1 therapy

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 27 Apr 2023

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At a glance

  • Drugs Mitazalimab (Primary)
  • Indications Carcinoma; Urogenital cancer
  • Focus Therapeutic Use
  • Acronyms OPTIMIZE-2
  • Sponsors Alligator Bioscience

    • Most Recent Events

    • 25 Apr 2023 According to an Alligator Bioscience media release, FDA authorizes initiation of mitazalimab OPTIMIZE-2 Phase 2 trial in urothelial carcinoma.
    • 01 Apr 2023 According to an Alligator Bioscience media release, the company expects to begin this study in H1 2024, or earlier, subject to operational feasibility.
    • 01 Apr 2023 According to an Alligator Bioscience media release, the company has cleared the Investigational New Drug (IND) application to initiate this study.

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