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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

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: 28 Apr 2026

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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

  • 21 Apr 2026 According to a Cogent Biosciences media release, New Drug Application was submitted under the Real-Time Oncology Review (RTOR) program in March 2026.
  • 21 Apr 2026 According to a Cogent Biosciences media release, company announced that the results from the Phase 3 PEAK trial have been selected for oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, IL, May 29-June 2, 2026
  • 17 Feb 2026 According to a Cogent Biosciences media release, complete submission of PEAK NDA anticipated in April 2026 for bezuclastinib in patients with GIST who have received prior treatment with imatinib.

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