drugset
drugset / Trial / NCT04996875

(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis

NCT04996875 ↗

Phase 2 Recruiting 140 enrolled Cogent Biosciences, Inc.
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).

Timeline

Start
2021-11-09
Primary completion
2025-09-19
Completion
2027-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Bezuclastinib Small molecule — Oral

Indications

aggressive systemic mastocytosis mast cell leukemia systemic mastocytosis with an associated clonal hematologic non-mast cell lineage disease