# (Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis

Source: https://onco.cc/trials/nct05186753/  
OnCo record `nct05186753` (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., active and no longer recruiting.

## Summary

(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis is a phase 2 interventional study registered as NCT05186753 by Cogent Biosciences, Inc., with 237 participants planned, started 2022-06-27 and due to reach its primary completion in 2025-05-22. Interventions recorded: Bezuclastinib Tablets (Formulation A), Bezuclastinib Tablets (Formulation B), Placebo Tablets. Conditions listed: SSM, Mastocytosis, Indolent, Mastocytosis, Systemic, Mastocytosis. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: ctgov-ingest
- Registry id: NCT05186753
- Phase: 2
- Setting: A Multi-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study of The Safety and Efficacy of CGT9486 in Subjects With Nonadvanced Systemic Mastocytosis
- Sponsor: Cogent Biosciences, Inc.
- Enrolled: 237

## Sources

- ClinicalTrials.gov NCT05186753: https://clinicaltrials.gov/study/NCT05186753

## 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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