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1. Part 1: Determine recommended dose of bezuclastinib (CGT9486) in subjects with NonAdvSM (Time Frame - 3 months): Selection of the recommended dose to be used in subsequent parts of the study.
2. Part 2: Efficacy of bezuclastinib at the selected dose versus placebo (Time Frame - 6 months): Mean absolute change in a disease-specific patient reported outcome (PRO)
3. Part 3: Safety and tolerability of bezuclastinib as assessed by number of adverse events (Time Frame - Up to 24 months): CTCAE v5
Secondary outcome:
1. Safety and tolerability of bezuclastinib as assessed by number of adverse events (Time Frame - Up to 24 months): CTCAE v5
2. Proportion of subjects who had at least 50% reduction in serum tryptase (Time Frame - Up to 24 months)
3. Proportion of subjects who had at least 50% reduction in mast cell burden (Time Frame - Up to 24 months)
4. Proportion of subjects who had at least a 50% reduction in peripheral blood D816V allele fraction (Time Frame - Up to 24 months)
5. Change and percent change in patient reported outcome (PRO) measures (Time Frame - Up to 24 months)
6. Change and percent change in serum tryptase (Time Frame - Up to 24 months)
7. Change and percent change in bone marrow mast cells (Time Frame - Up to 24 months)
8. Change and percent change in the levels of KIT D816V mutation allele burden (Time Frame - Up to 24 months)
9. Assess the pharmacokinetics (PK) of bezuclastinib in subjects with NonAdvSM (Time Frame - Up to 24 months): Plasma concentrations of CGT9846
10. Change and percent change in the Mast Cell Quality of Life (MC-QOL) Score (Time Frame - up to 24 months): Scale of 0-100, higher numbers represent more severe impairment to quality of life.
11. Change and percent change in 12-item Short Form Health Survey (SF-12) (Time Frame - up to 24 months): Scale of 0-100, higher numbers represent better symptom outcomes
12. Change and percent change in EuroQol 5 Dimensions 5 Levels (EQ 5D-5L) (Time Frame - up to 24 months): Scale of 0-100, higher numbers represent better symptom outcomes
13. Determine responder rates of subjects treated with bezuclastinib at the selected dose (Time Frame - 6 months): Response rate based on reduction in disease specific PRO