Bezuclastinib

Bezuclastinib (CGT9486) is a small-molecule drug developed by Cogent Biosciences. Its targets are KIT and MET (the sponsor names KIT (including KIT D816V)). The sponsor states: Bezuclastinib (CGT9486/PLX9486) is a selective tyrosine kinase inhibitor designed to potently inhibit KIT driver mutations, including the KIT D816V mutation that drives systemic mastocytosis, and is combined with sunitinib versus sunitinib alone in gastrointestinal stromal tumours. ClinicalTrials.gov describes the intervention as: Participants will receive CGT9486 orally until study stopping rules are met. It is the investigational product in 1 recruiting or active industry-led phase 2 and phase 3 interventional cancer trial, including the phase 3 study NCT05208047 ((Peak) A Phase 3 Randomised Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumours), in gastrointestinal stromal tumour. The largest, NCT05208047, plans to enrol 482 participants with primary completion expected 2025-09-30. Status reflects the highest phase registered on ClinicalTrials.gov at the 2026-09-11 check; no efficacy results are recorded here.