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(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis

NCT04996875 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-05-05

No results posted yet for this study

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).

Conditions

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

Interventions

DRUG

bezuclastinib

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

Sponsors & Collaborators

  • Cogent Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Rachael Easton, MD, Ph.D. · Cogent Biosciences, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-09
Primary Completion
2025-09-19
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04996875 on ClinicalTrials.gov