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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: Recruiting
Phase of Trial: Phase III

Latest Information Update: 23 May 2024

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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

    • 07 May 2024 According to a Cogent Biosciences media release, company to share updated clinical data from the lead-in portion of the PEAK trial at the American Society of Clinical Oncology (ASCO) annual meeting taking place May 31-June 4, 2024.
    • 22 Feb 2024 According to a Cogent Biosciences media release, company continues to actively enroll the global Phase 3 PEAK trial and expects to complete enrollment by the end of 2024, with top-line results expected by the end of 2025.
    • 14 Feb 2024 According to a Cogent Biosciences media release, company intends to use the net proceeds from the proposed financing to fund research and development, activities relating to bezuclastinib and other product candidates, as well as for working capital and general corporate purposes. The proceeds from this financing, combined with current cash, cash equivalents and marketable securities, are expected to fund Cogent into 2027 and through all clinical readouts from SUMMIT, PEAK and APEX trials.
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