A Phase 2 Open-Label, Multicenter Clinical Study of The Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients with Advanced Systemic Mastocytosis

Advanced Systemic Mastocytosis

Part 1: Dose Optimization - Safety assessments and dose modifications; - PK and pharmacodynamic assessments; - Overall response rate (ORR), Part 2 Stage 1: Dose Confirmation - Safety assessments and dose modifications - PK and pharmacodynamic assessments - Overall response rate (ORR), Part 2 Stage 2: Expansion - Overall response rate (ORR)

Part 1 and Part 2: Incidence of AEs, SAEs, AEs leading to dose modifications, and changes from baseline in laboratory results, Part 1 and Part 2: Duration Of Response (DOR), Time to Response (TTR), Progression Free Survival (PFS), Overall Survival (OS), Pure Pathologic Response (PPR), Part 1 and Part 2: Changes in the levels of serum tryptase, Part 1 and Part 2: Changes in the levels of KIT D816V mutation allele burden in blood and bone marrow, Part 1 and Part 2: Change in pathologic findings in the blood and bone marrow including mast cell infiltration, monocytosis, and eosinophilia, Part 1 and Part 2: Plasma concentrations of bezuclastinib, Part 1 and Part 2: Change from baseline in PGIS, PGIC, MC-QoL and MAS

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