NCT04996875Phase 2Recruiting

(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis

Study sponsor: Cogent Biosciences, Inc. · COGT

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2025-09-19Actual

Enrollment · participants140Estimated

Source updated2026-09-15Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-04-24 · 2 fields changed

Completion date type

Recorded edit

− Previous value

Estimated

+ Updated value

Actual

Primary completion date

Recorded edit

− Previous value

2025-09

+ Updated value

2025-09-19

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Study details

Conditions studied

Advanced Systemic Mastocytosis (AdvSM); SM With an Associated Hematologic Neoplasm (SM-AHN); Mast Cell Leukemia (MCL); Aggressive Systemic Mastocytosis (ASM)

Treatments or interventions studied

bezuclastinibDrugAlso known as CGT9486, PLX9486

Primary outcomes · main study measures

measure: Part I: Identify clinically active and tolerable exposures of bezuclastinib in patients with AdvSM; timeFrame: 18 months; measure: Part II: - Determine efficacy of bezuclastinib as measured by mIWG Objective Response Rate (ORR) - Confirm the exposure-response relationship of bezuclastinib; timeFrame: 18 months

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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