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A registrational trial of AGEN-1181 in combination with Balstilimab

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Trial Profile

A registrational trial of AGEN-1181 in combination with Balstilimab

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 22 Jul 2024

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At a glance

  • Drugs Balstilimab (Primary) ; Botensilimab (Primary)
  • Indications Colorectal cancer; Solid tumours
  • Focus Registrational; Therapeutic Use
  • Sponsors Agenus
  • Most Recent Events

    • 18 Jul 2024 According to an Agenus media release, The FDA recommended the inclusion of a BOT monotherapy arm at Agenus' discretion in the Phase 3 study.
    • 05 May 2024 According to an Agenus media release, today announced that the companies have entered into a royalty financing agreement to support Agenus' key development initiatives in the ongoing BOT/BAL clinical development program, including its planned confirmatory Phase 3 trial in its lead indication of patients with metastatic, relapsed/refractory colorectal cancer.
    • 07 Nov 2023 According to an Agenus media release, company plans to submit an EU marketing authorization filing in 2025. Interactions with regulatory agencies are ongoing.

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