(Apex) Bezuclastinib in Patients with Advanced Systemic Mastocytosis

Description

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)

Study Overview

Study Details

Study overview

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).

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

(Apex) Bezuclastinib in Patients with Advanced Systemic Mastocytosis

Condition
Advanced Systemic Mastocytosis (AdvSM)
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham (UAB) Hospital, Birmingham, Alabama, United States, 35233

Phoenix

Mayo Clinic Arizona, Phoenix, Arizona, United States, 85054

Duarte

City of Hope Comprehensive Cancer Center, Duarte, California, United States, 91010

Los Angeles

UCLA Medical Center, Los Angeles, California, United States, 90095

Stanford

Stanford Cancer Institute, Stanford, California, United States, 94305

Hialeah

Galiz Research, Hialeah, Florida, United States, 33016

Atlanta

Winship Cancer Institute - Emory University, Atlanta, Georgia, United States, 30322

Chicago

Rush University Medical Center, Chicago, Illinois, United States, 60612

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

New York

Columbia University Irving Medical Center, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Cogent Biosciences, Inc.,

    Rachael Easton, MD, Ph.D., STUDY_DIRECTOR, Cogent Biosciences, Inc.

    Study Record Dates

    2026-07