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
Latest Information Update: 28 Apr 2026
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.