(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Cogent Biosciences, Inc.
Study ID
NCT04996875
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Nov 9, 2021
Status verified
Apr 2026
Primary completion
Sep 19, 2025
Completion
Jul 31, 2027

Study Design

Enrollment
140 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: bezuclastinib

Primary Outcome Measure

Part I: Identify clinically active and tolerable exposures of bezuclastinib in patients with AdvSM [ Time Frame: 18 months ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham (UAB) HospitalBirminghamAlabama35233-
Mayo Clinic ArizonaPhoenixArizona85054-
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
UCLA Medical CenterLos AngelesCalifornia90095-
Stanford Cancer InstituteStanfordCalifornia94305-
Galiz ResearchHialeahFlorida33016-
Winship Cancer Institute - Emory UniversityAtlantaGeorgia30322-
Rush University Medical CenterChicagoIllinois60612-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Columbia University Irving Medical CenterNew YorkNew York10032-
Cleveland Clinic Taussig Cancer CenterClevelandOhio44106-
MUSC Health University Medical CenterCharlestonSouth Carolina29425-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Huntsman Cancer Institute - University of Utah HealthSalt Lake CityUtah84112-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham (UAB) Hospital· Birmingham, ALMayo Clinic Arizona· Phoenix, AZCity of Hope Comprehensive Cancer Center· Duarte, CAUCLA Medical Center· Los Angeles, CAStanford Cancer Institute· Stanford, CAGaliz Research· Hialeah, FL