Clinical Trial

(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis

Recruiting Phase 2
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Summary
This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).
Protocol Amendment History 26 amendments
This ClinicalTrials.gov record has been amended 26 times since 2021-08-06; most recent amendment 2026-04-29.
Trial Details
NCT Number NCT04996875
Lead Sponsor Cogent Biosciences, Inc.
Conditions Advanced Systemic Mastocytosis (AdvSM), SM With an Associated Hematologic Neoplasm (SM-AHN), Mast Cell Leukemia (MCL), Aggressive Systemic Mastocytosis (ASM)
Enrollment 140 participants
Start Date 2021-11-09
Primary Completion 2025-09-19 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-07-31