Bezuclastinib for Systemic Mastocytosis
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications before participating. Specifically, you must not have received any cytoreductive therapy or investigational agents less than 14 days before the study, and certain medications like cladribine, interferon alpha, pegylated interferon, and antibody therapy must be stopped 28 days before. Additionally, you cannot take strong CYP3A4 inhibitors or inducers within 14 days or 5 drug half-lives before the first dose of the study drug.
What data supports the effectiveness of the drug Bezuclastinib for treating systemic mastocytosis?
While there is no direct data on Bezuclastinib, similar drugs like avapritinib, which target the same mutation (KITD816V) found in most systemic mastocytosis cases, have shown promising results. Avapritinib has demonstrated a 72% overall response rate in patients with advanced systemic mastocytosis, suggesting that targeting this mutation can be effective.12345
How is the drug Bezuclastinib different from other drugs for systemic mastocytosis?
What is the purpose of this trial?
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).
Research Team
Rachael Easton, MD, Ph.D.
Principal Investigator
Cogent Biosciences, Inc.
Eligibility Criteria
This trial is for patients with Advanced Systemic Mastocytosis, including Aggressive SM, SM with an Associated Hematologic Neoplasm, or Mast Cell Leukemia. Participants must have measurable disease and be in a stable enough condition (ECOG 0 to 3). They can't join if they have HIV, hepatitis B/C, other recent cancers, significant heart issues or bleeding events, unresolved toxicity from past treatments or need certain medications like strong CYP3A4 inhibitors.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CGT9486 for the treatment of Advanced Systemic Mastocytosis
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Bezuclastinib
- CGT9486 tablets
Bezuclastinib is already approved in European Union, United States for the following indications:
- Orphan designation for Gastrointestinal stromal tumours and Systemic mastocytosis
- Orphan designation for Gastrointestinal stromal tumours and Systemic mastocytosis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cogent Biosciences, Inc.
Lead Sponsor