Trials / Recruiting
RecruitingNCT04996875
(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- Sponsor
- Cogent Biosciences, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
- Advanced Systemic Mastocytosis (AdvSM)
- SM With an Associated Hematologic Neoplasm (SM-AHN)
- Mast Cell Leukemia (MCL)
- Aggressive Systemic Mastocytosis (ASM)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | bezuclastinib | Bezuclastinib is administered as tablets to be taken orally, continuously in 28-day cycles. |
Timeline
- Start date
- 2021-11-09
- Primary completion
- 2025-09-01
- Completion
- 2026-07-01
- First posted
- 2021-08-09
- Last updated
- 2025-05-30
Locations
42 sites across 14 countries: United States, Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Norway, Poland, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04996875. Inclusion in this directory is not an endorsement.