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A Phase 3 Randomized, Open-Label, Multicenter Clinical Study of CGT9486+Sunitinib vs. Sunitinib in Subjects With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors

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Trial Profile

A Phase 3 Randomized, Open-Label, Multicenter Clinical Study of CGT9486+Sunitinib vs. Sunitinib in Subjects With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 16 Jun 2025

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At a glance

  • Drugs Bezuclastinib (Primary) ; Sunitinib (Primary)
  • Indications Gastrointestinal stromal tumours
  • Focus Pharmacokinetics; Registrational; Therapeutic Use
  • Acronyms PEAK
  • Sponsors Cogent Biosciences

Most Recent Events

  • 11 Jun 2025 According to a Cogent Biosciences Media Release, before the end of 2025, company expects to release results from PEAK study.
  • 11 Jun 2025 According to a Cogent Biosciences Media Release, An additional $100 million is available during 2025 at Cogent's discretion, subject to successful top-line data readouts from SUMMIT and PEAK bezuclastinib pivotal trials.
  • 13 Jan 2025 According to a Cogent Biosciences Media Release, company plans to report top-line results from all three registration-directed bezuclastinib studies, and if successful, move forward with our first New Drug Application (NDA) submission by the end of 2025.

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