The purpose of this expanded access program (EAP) protocol is to provide investigational bezuclastinib to patients with a diagnosis of nonadvanced systemic mastocytosis (NonAdvSM) or advanced systemic mastocytosis (AdvSM) who have received and failed or been intolerant to at least one standard approved therapy and/or have no comparable or satisfactory alternative therapy options.
Protocol Amendment History
13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2025-03-31; most recent amendment 2026-07-10.