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(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis
NCT04996875 · View on ClinicalTrials.gov ↗
Study 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).
Conditions Studied
Interventions
- DRUG bezuclastinib
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center — Duarte
- UCLA Medical Center — Los Angeles
- Stanford Cancer Institute — Stanford
Other
- AKH Wien, Universitatsklinikum — Vienna
- CHU de Liege — Liège
Alabama
- University of Alabama at Birmingham (UAB) Hospital — Birmingham
Arizona
- Mayo Clinic Arizona — Phoenix
Florida
- Galiz Research — Hialeah
Georgia
- Winship Cancer Institute - Emory University — Atlanta
Illinois
- Rush University Medical Center — Chicago
Massachusetts
- Dana-Farber Cancer Institute — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2021-11-09 |
| Est. Completion | 2026-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04996875
The ClinicalTrials.gov registry entry for NCT04996875 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cogent Biosciences, which has 64 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Advanced Systemic Mastocytosis (AdvSM) appearing as the primary indexed condition, and to 1 intervention — of which bezuclastinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04996875 reports 20 study locations spanning 17 distinct geographic areas — top geographies include California, Other, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04996875 about?
NCT04996875 is a clinical study titled "(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis". 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).
What is the current status of trial NCT04996875?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2021-11-09. Estimated completion is 2026-07.
What conditions does trial NCT04996875 study?
This clinical trial studies the following conditions: Advanced Systemic Mastocytosis (AdvSM), SM With an Associated Hematologic Neoplasm (SM-AHN), Mast Cell Leukemia (MCL), Aggressive Systemic Mastocytosis (ASM). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04996875?
The interventions under investigation include: bezuclastinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04996875?
This trial is sponsored by Cogent Biosciences, which has 64 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04996875 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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