Status:
ACTIVE_NOT_RECRUITING
(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis
Lead Sponsor:
Cogent Biosciences, Inc.
Conditions:
SSM
Mastocytosis, Indolent
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Key
- 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)
- 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
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
- For patients receiving corticosteroids, the dose must be ≤10 mg/day of prednisone or equivalent
- Key
Exclusion
- Persistent toxicity from previous therapy for NonAdvSM that has not resolved to ≤ Grade 1
- 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
- Diagnosed with mastocytosis of the skin without systemic involvement
- Received prior treatment with any targeted KIT inhibitor with the exception of approved agents for the treatment of SM
- 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
- Received radiotherapy or psoralen and ultraviolet A therapy \<14 days before starting screening assessments
- Received any hematopoietic growth factor support \<14 days or 5 half lives of the drug before starting screening assessments
- History of clinically significant bleeding event within 30 days before the first dose of study drug or need for therapeutic anticoagulation on study
- Need for treatment of corticosteroids at \>10 mg/day of prednisone or equivalent
- Received strong CYP3A4 inhibitors or inducers within 14 days or 5 drug half-lives before the first dose of study drug
Key Trial Info
Start Date :
June 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2030
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT05186753
Start Date
June 27 2022
End Date
April 1 2030
Last Update
October 29 2025
Active Locations (69)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
3
One of a Kind Clinical Research Center
Scottsdale, Arizona, United States, 85258
4
Modena Allergy and Asthma Clinical
La Jolla, California, United States, 92037