Bezuclastinib

DRUG3 trials

Sponsors

Cogent Biosciences, Inc.

Conditions

Advanced Systemic Mastocytosis (AdvSM)Aggressive Systemic Mastocytosis (ASM)Gastrointestinal Neoplasms, Gastrointestinal Stromal TumorsMast Cell Leukemia (MCL)SM With an Associated Hematologic Neoplasm (SM-AHN)Systemic Mastocytoses, AggressiveSystemic Mastocytoses, Indolent

Phase 2

(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis

RecruitingNCT04996875

Cogent Biosciences, Inc.Advanced Systemic Mastocytosis (AdvSM), Aggressive Systemic Mastocytosis (ASM), Mast Cell Leukemia (MCL) +1

Start: 2021-11-09End: 2027-07-01Target: 140Updated: 2026-09-15

Unknown Phase

Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis

Cogent Biosciences, Inc.Systemic Mastocytoses, Aggressive, Systemic Mastocytoses, Indolent

Updated: 2026-07-13

Expanded Access to Bezuclastinib to be Coadministered With Sunitinib for Patients With Gastrointestinal Stromal Tumors

Cogent Biosciences, Inc.Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors

Updated: 2026-07-13

Related Papers

Apex Part 1: Updated Assessment of Bezuclastinib (CGT9486), a Selective KIT D816V Tyrosine Kinase Inhibitor, in Patients with Advanced Systemic Mastocytosis (AdvSM)

Blood2024-11-053 citations

Apex Part 2 Trial in Progress: A Phase 2 Open-Label Clinical Study of Bezuclastinib in Adult Patients with Advanced Systemic Mastocytosis

Blood2024-11-05

Safety and Efficacy of Bezuclastinib (CGT9486), a Novel, Highly Selective, Potent KIT D816V Tyrosine Kinase Inhibitor, in Patients with Advanced Systemic Mastocytosis (AdvSM): Results from Part 1 of the Phase 2 Apex Trial

Blood2023-11-024 citations

Preliminary Safety and Efficacy from Apex, a Phase 2 Study of Bezuclastinib (CGT9486), a Novel, Highly Selective, Potent <i>KIT</i> D816V Tyrosine Kinase Inhibitor, in Adults with Advanced Systemic Mastocytosis (AdvSM)

Blood2022-11-1513 citations

Abstract 147: Bezuclastinib is a differentiated KIT inhibitor that exhibits unique selectivity to KIT A-loop mutations, minimal brain penetration, and favorable pharmacokinetic properties in preclinical models

Cancer Research2022-06-153 citations

P1049: A PHASE 2 STUDY OF BEZUCLASTINIB (CGT9486), A NOVEL, HIGHLY SELECTIVE, POTENT KIT D816V INHIBITOR, IN ADULTS WITH ADVANCED SYSTEMIC MASTOCYTOSIS (APEX): METHODS, BASELINE DATA, AND EARLY INSIGHTS

HemaSphere2022-06-018 citations