CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 140 target
Drug / intervention
bezuclastinibdrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Diagnosed with Aggressive Systemic Mastocytosis (ASM), Systemic Mastocytosis with an Associated Hematologic Neoplasm (SM-AHN), or Mast Cell Leukemia (MCL)
  • ✓Measurable disease according to modified IWG-MRT-ECNM criteria
  • ✓ECOG performance status 0 to 3
  • ✓Clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits
Key exclusion· 8
  • ✕Persistent toxicity from previous therapy for AdvSM that has not resolved to ≤ Grade 1
  • ✕Associated hematologic neoplasm requiring immediate antineoplastic therapy
  • ✕Clinically significant cardiac disease
  • ✕Known positivity for FIP1L1 PDGFRA fusion; eosinophilia without detectable KIT D816V must demonstrate lack of PDGFRA fusion

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04996875
NCT04996875Phase 2RecruitingUpdate OverdueCompletion was 9mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

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

Cogent Biosciences, Inc.·interventional·Posted Aug 9, 2021·Updated May 5, 2026

In Brief

A Phase 2 clinical trial evaluating bezuclastinib for Advanced Systemic Mastocytosis (AdvSM) and 3 related conditions. Currently recruiting, targeting 140 participants across 42 sites in 14 countries.

Signals

Enrollment appears stalled

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Systemic Mastocytosis (AdvSM), SM With an Associated Hematologic Neoplasm (SM-AHN), Mast Cell Leukemia (MCL), Aggressive Systemic Mastocytosis (ASM)
CountriesAustralia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Norway, Poland, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 2Recruiting
202220232024202520262027
First PostedAug 9, 2021
Enrollment StartNov 9, 2021
Primary CompletionSep 19, 2025
Study CompletionJul 1, 2027
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 4.9 years ago

Interventions

bezuclastinibdrug

Bezuclastinib is administered as tablets to be taken orally, continuously in 28-day cycles.