OncoMatch/Clinical Trials/NCT04996875
(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis
Is NCT04996875 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies bezuclastinib for advanced systemic mastocytosis (advsm).
Treatment: bezuclastinib — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Myeloproliferative Neoplasm
Acute Myeloid Leukemia
Biomarker criteria
Excluded: FIP1L1 PDGFRA fusion
Known positivity for the FIP1L1 PDGFRA fusion. Patients with eosinophilia without detectable KIT D816V mutation must demonstrate lack of PDGFRA fusion mutation prior to enrollment
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Cannot have received: cytoreductive therapy
Received any cytoreductive therapy or any investigational agent less than 14 days, and for cladribine, interferon alpha, pegylated interferon, and any antibody therapy less than 28 days, before screening bone marrow biopsy
Cannot have received: hematopoietic growth factor support
Received hematopoietic growth factor support within 14 days before the first dose of study drug
Lab requirements
Blood counts
clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits
Kidney function
clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits
Liver function
clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits
Have clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham (UAB) Hospital · Birmingham, Alabama
- Mayo Clinic Arizona · Phoenix, Arizona
- City of Hope Comprehensive Cancer Center · Duarte, California
- UCLA Medical Center · Los Angeles, California
- Stanford Cancer Institute · Stanford, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04996875 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior cytoreductive therapy, hematopoietic growth factor support disqualifies patients from enrollment.
Are patients with FIP1L1 alterations eligible?
No. FIP1L1 PDGFRA fusion is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify