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ACTIVE NOT RECRUITING

NCT05186753

PHASE2

(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis

Sponsor: Cogent Biosciences, Inc.

View on ClinicalTrials.gov

Summary

This is a multi-part, randomized, double-blind, placebo-controlled Phase 2 clinical study comparing the safety and efficacy of bezuclastinib (CGT9486) plus best supportive care (BSC) with placebo plus BSC in patients with nonadvanced systemic mastocytosis (NonAdvSM), including indolent systemic mastocytosis and smoldering systemic mastocytosis, whose symptoms are not adequately controlled by BSC. This study will be conducted in three parts. Patients in Parts 1a, 1b and 2 will receive bezuclastinib or placebo, and may roll over onto Part 3 to receive treatment with bezuclastinib. Additionally, a substudy of subjects will investigate the efficacy, safety, and tolerability of bezuclastinib in patients who are experiencing inadequate symptom control with avapritinib.

Official title: A Multi-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study of The Safety and Efficacy of CGT9486 in Subjects With Nonadvanced Systemic Mastocytosis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

237

Start Date

2022-06-27

Completion Date

2030-04

Last Updated

2026-03-04

Healthy Volunteers

Conditions

SSM Mastocytosis, Indolent Mastocytosis, Systemic Mastocytosis ISM BMM Smoldering Systemic Mastocytosis Bone Marrow Mastocytosis

Interventions

DRUG

Bezuclastinib Tablets (Formulation A)

Bezuclastinib will be administered orally, once daily continuously for 28-day cycles

DRUG

Bezuclastinib Tablets (Formulation B)

Bezuclastinib will be administered orally, once daily continuously for 28-day cycles

DRUG

Placebo Tablets

Placebo will be administered orally, once daily continuously for 28-day cycles

Key Inclusion Criteria: 1. Diagnosed with 1 of the following diagnoses according to the 2016 World Health Organization (WHO) classification for systemic mastocytosis (SM): * Indolent systemic mastocytosis (ISM), * Bone marrow mastocytosis (BMM) * Smoldering systemic mastocytosis (SSM) 2. Moderate-to-severe symptoms based on a minimum total symptom scoew (TSS) of the Mastocytosis Activity Score (MAS) and after establishing a stable regimen of at least 2 antimediator therapies over a 14-day eligibility period 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2 4. For patients receiving corticosteroids, the dose must be ≤10 mg/day of prednisone or equivalent Key Exclusion Criteria: 1. Persistent toxicity from previous therapy for NonAdvSM that has not resolved to ≤ Grade 1 2. Diagnosed with any of the following WHO SM classifications: bone marrow mastocytosis, advanced systemic mastocytosis including SM with associated hematologic neoplasm, aggressive SM, mast cell leukemia; or mast cell sarcoma 3. Diagnosed with mastocytosis of the skin without systemic involvement 4. Received prior treatment with any targeted KIT inhibitor with the exception of approved agents for the treatment of SM 5. Received prior cytoreductive therapy or investigational agent for \<14 days or 5 half- lives of the drug and for cladribine, interferon alpha, pegylated interferon, or antibody therapy \<28 days or 5 half-lives of the drug (whichever is longer), before starting screening assessments 6. Received radiotherapy or psoralen and ultraviolet A therapy \<14 days before starting screening assessments 7. Received any hematopoietic growth factor support \<14 days or 5 half lives of the drug before starting screening assessments 8. History of clinically significant bleeding event within 30 days before the first dose of study drug or need for therapeutic anticoagulation on study 9. Need for treatment of corticosteroids at \>10 mg/day of prednisone or equivalent 10. Received strong CYP3A4 inhibitors or inducers within 14 days or 5 drug half-lives before the first dose of study drug

Locations (57)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Mayo Clinic Arizona

Phoenix, Arizona, United States

One of a Kind Clinical Research Center

Scottsdale, Arizona, United States

Modena Allergy and Asthma Clinical

La Jolla, California, United States

Innovative Research of West Florida

Clearwater, Florida, United States

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

University of South Florida

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

Rush University

Chicago, Illinois, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Allervie Clinical Research

Glenn Dale, Maryland, United States

Institute for Asthma and Allergy

Wheaton, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Washington University at St. Louis

St Louis, Missouri, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Duke University

Raleigh, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

AIR Care

Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Metrodora Institute of Technology

West Valley City, Utah, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Antwerp University Hospital (UZA)

Edegem, Belgium

CHU Tivoli

La Louvière, Belgium

Tom Baker Cancer Centre

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Fakultni nemocnice Kralovske Vinohrady

Prague, Czechia

AP-HP- Hopital Pitie-Salpetriere

Paris, France

CHU de Toulouse - Hopital Larrey

Toulouse, France

Universitaetsklinikum Aachen, AoeR

Aachen, Germany

Charité Universitätsmedizin Berlin

Berlin, Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, Germany

Universitätsklinikum Schleswig-Holstein

Kiel, Germany

University Medical Centre Mannheim

Mannheim, Germany

Cork University Hospital

Cork, Ireland

St. James's Hospital

Dublin, Ireland

IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola

Bologna, Italy

AOU Policlinico Rodolico San Marco

Catania, Italy

Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

AUSL della Romagna-Ospedale S.Maria delle Croci

Ravenna, Italy

University Medical Center Groningen

Groningen, Netherlands

Erasmus Rotterdam

Rotterdam, Netherlands

Oslo University Hospital

Oslo, Norway

Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii

Gdansk, Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1 - Klinika Hematoonkologii i Transplantacji Szpiku

Lublin, Poland

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Institut Catala d'Oncologia - L'Hospitalet

Barcelona, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Instituto de Estudios de Mastocitosis de Castilla La Mancha-Hospital Virgen del Valle

Toledo, Spain

University Hospital Basel

Basel, Switzerland

Guy's Hospital

London, United Kingdom

Clinical Research Directory

(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (57)