RecruitingPhase 2NCT04996875

(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis

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

Sponsor

Cogent Biosciences, Inc.

Enrollment

140 participants

Start Date

Nov 9, 2021

Study Type

INTERVENTIONAL

Conditions

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

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (APEX) tests bezuclastinib, a drug that targets the KIT gene mutation, in patients with advanced systemic mastocytosis — a rare disease where abnormal mast cells accumulate in organs like the liver, spleen, and bone marrow causing serious organ damage. **You may be eligible if...** - You have been diagnosed with aggressive systemic mastocytosis, systemic mastocytosis with an associated blood cancer (SM-AHN), or mast cell leukemia - You have measurable disease - You are in adequate health (ECOG 0–3) - Your blood and chemistry results meet acceptable ranges **You may NOT be eligible if...** - You have serious heart disease - You are HIV-positive, or have active hepatitis B or C - You have had another cancer in the past 3 years - You have clinically significant bleeding in the last 30 days or require therapeutic anticoagulation - You have a specific genetic abnormality called the PDGFRA fusion mutation - You received prior cytoreductive therapy or investigational agents within 14 days (28 days for certain drugs) - You need high-dose steroid treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGbezuclastinib

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

Locations(42)

University of Alabama at Birmingham (UAB) Hospital

Birmingham, Alabama, United States

Mayo Clinic Arizona

Phoenix, Arizona, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

UCLA Medical Center

Los Angeles, California, United States

Stanford Cancer Institute

Stanford, California, United States

Galiz Research

Hialeah, Florida, United States

Winship Cancer Institute - Emory University

Atlanta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Columbia University Irving Medical Center

New York, New York, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

MUSC Health University Medical Center

Charleston, South Carolina, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute - University of Utah Health

Salt Lake City, Utah, United States

Nepean Hospital

Kingswood, New South Wales, Australia

Gold Coast University Hospital

Southport, Queensland, Australia

Peter MacCallum Cancer Centre

Melbourne N., Victoria, Australia

AKH Wien, Universitatsklinikum

Vienna, Austria

CHU de Liege

Liège, Belgium

University of Alberta Hospital

Edmonton, Alberta, Canada

St. Michael's Hospital - Unity Health Toronto

Toronto, Ontario, Canada

Necker-Enfants Malades Hospital

Paris, France

Centre Hospitalier Universitaire (CHU) de Poitiers

Poitiers, France

Centre Hospitalier Universitaire (CHU) de Toulouse

Toulouse, France

University Hospital Aachen

Aachen, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

UKSH Campus Lubeck

Lübeck, Germany

Universitätsklinikum Mannheim

Mannheim, Germany

IRCCS Azienda Ospedaliero Universitaria di Bologna

Bologna, Italy

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

AOU San Giovanni di Dio e Ruggi dAragonia

Salerno, Italy

Azienda Ospidaleira Universitaria Integrata Verona

Verona, Italy

University Medical Center Groningen

Groningen, Netherlands

Oslo University Hospital

Oslo, Norway

Public University Hospital No. 1 in Lublin

Lublin, Poland

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Institut Català d'Oncologia - Hospital Duran i Reynals

Barcelona, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Universitätsspital Basel

Basel, Switzerland

Guy's Hospital - NHS Foundation Trust

London, London, United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

University College London Hospital - NHS Foundation Trust

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04996875