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
Cogent Biosciences, Inc.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria for Main Study: 1. Diagnosed with one of the following advanced mastocytosis diagnoses by Eligibility Committee 1. Aggressive Systemic Mastocytosis (ASM) 2. Systemic Mastocytosis with an Associated Hematologic Neoplasm (SM-AHN) 3. Mast Cell Leukemia (MCL) 2. Measurable disease according to modified IWG-MRT-ECNM criteria. (A subset of patients inevaluble per mIWG-MRT-ECNM will be included in the study). 3. ECOG (0 to 3) 4. Have clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits Key Exclusion Criteria…
Interventions
- Drugbezuclastinib
Bezuclastinib is administered as tablets to be taken orally, continuously in 28-day cycles.
Locations (42)
- University of Alabama at Birmingham (UAB) HospitalBirmingham, Alabama
- Mayo Clinic ArizonaPhoenix, Arizona
- City of Hope Comprehensive Cancer CenterDuarte, California
- UCLA Medical CenterLos Angeles, California
- Stanford Cancer InstituteStanford, California
- Galiz ResearchHialeah, Florida