(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis
← catalyst calendarSponsored by Cogent Biosciences, Inc. (industry) · COGT — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
140estimated
Sites
42
Countries
Australia, Austria, Belgium +11
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-11-09 | actual | When the study began enrolling |
| Primary completion | 2025-09-19 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2021-08-09 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-31 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Advanced Systemic Mastocytosis (AdvSM)
- SM With an Associated Hematologic Neoplasm (SM-AHN)
- Mast Cell Leukemia (MCL)
- Aggressive Systemic Mastocytosis (ASM)
Intervention
- Drug: bezuclastinib — also filed as CGT9486, PLX9486
Primary outcomes
what the primary-completion date above is the date OFPart I: Identify clinically active and tolerable exposures of bezuclastinib in patients with AdvSM
measured 18 months
Part II: - Determine efficacy of bezuclastinib as measured by mIWG Objective Response Rate (ORR) - Confirm the exposure-response relationship of bezuclastinib
measured 18 months
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