(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis

About

Brief 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).

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase II

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

Key Inclusion Criteria:

Diagnosed with 1 of the following advanced mastocytosis diagnoses by Eligibility Committee
- Aggressive Systemic Mastocytosis (ASM)
- Systemic Mastocytosis with an Associated Hematologic Neoplasm (SM-AHN)
- Mast Cell Leukemia (MCL)
Measurable disease according to modified IWG-MRT-ECNM criteria. (A subset of patients inevaluble per mIWG-MRT-ECNM will be included in the study).
ECOG (0 to 3)
Have clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits.

Key Exclusion Criteria:

Persistent toxicity from previous therapy for Advanced Systemic Mastocytosis that has not resolved to ≤ Grade 1
Associated hematologic neoplasm requiring immediate antineoplastic therapy
Clinically significant cardiac disease
Known positivity for the FIP1L1 PDGFRA fusion. Patients with eosinophilia without detectable KIT D816V mutation must also lack the PDGFRA fusion mutation prior to enrollment
Seropositive for human immunodeficiency virus (HIV) 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody
History of clinically significant bleeding event within 30 days before the first dose of study drug or need for therapeutic anticoagulation on study
Diagnosed with or treated for malignancy other than the disease under study within the prior 3 years before enrollment
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
Received hematopoietic growth factor support within 14 days before the first dose of study drug
Received strong CYP3A4 inhibitors or inducers within 14 days or 5 drug half-lives, whichever is longer, before the first dose of study drug.
Need for treatment with high dose steroids.

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