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SUMMIT study of CGT9486 in nonadvanced systemic mastocytosis
2022-501427-24-00Phase 2Authorised
- Sponsor
- Cogent Biosciences
- Start
- Apr 2023
- Modality
- Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Allosteric Modulators → Classical Binding Small Molecules → Small Molecules, Irreversible Covalent Inhibitors → Covalent Small Molecules → Small Molecules
- Countries
- 17
01
Overview
Phase 2, randomised, double-blind trial in systemic mastocytosis (SM), indolent systemic mastocytosis (ISM) and bone marrow mastocytosis (BMM) comparing CGT9486 with Placebo matching CGT9486 (2 arms). Primary endpoints: Safety, PK/PD, and symptom improvement, Week 24 mean absolute change in MS2D2 score and 1 more. Planned start Apr 2023; status: authorised.
02
Drugs
bezuclastinib
03
Conditions
systemic mastocytosis (SM)indolent systemic mastocytosis (ISM)bone marrow mastocytosis (BMM)
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