# (Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis

Source: https://onco.cc/trials/nct04996875/  
OnCo record `nct04996875` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2 trial of Bezuclastinib in systemic mastocytosis, run by Cogent Biosciences, Inc., now recruiting.

## Summary

(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis is a phase 2 interventional study registered as NCT04996875 by Cogent Biosciences, Inc., with 140 participants planned, started 2021-11-09 and due to reach its primary completion in 2025-09-19. Interventions recorded: bezuclastinib. Conditions listed: Advanced Systemic Mastocytosis (AdvSM), SM With an Associated Hematologic Neoplasm (SM-AHN), Mast Cell Leukemia (MCL), Aggressive Systemic Mastocytosis (ASM). No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: ctgov-ingest
- Registry id: NCT04996875
- Phase: 2
- Setting: 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
- Sponsor: Cogent Biosciences, Inc.
- Enrolled: 140

## Sources

- ClinicalTrials.gov NCT04996875: https://clinicaltrials.gov/study/NCT04996875

## Connected records

- cancers: [Systemic mastocytosis](https://onco.cc/cancers/systemic-mastocytosis/)
- drugs: [Bezuclastinib](https://onco.cc/drugs/bezuclastinib/)
- companies: [Cogent Biosciences](https://onco.cc/companies/cogent-biosciences/)

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