Actively Recruiting
(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis
Led by Cogent Biosciences, Inc. · Updated on 2026-05-05
140
Participants Needed
42
Research Sites
294 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Aggressive Systemic Mastocytosis (ASM), Systemic Mastocytosis with an Associated Hematologic Neoplasm (SM-AHN), or Mast Cell Leukemia (MCL) as confirmed by the Eligibility Committee
- Have measurable disease based on modified IWG-MRT-ECNM criteria
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 3
- Clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits
- For the Substudy Rollover Cohort: demonstrate AHN progression requiring immediate AHN-directed therapy while on bezuclastinib, clinical benefit from bezuclastinib, and acceptable lab results
- For the Substudy High-Risk Cohort: receiving or indicated for AHN-directed therapy, diagnosed with high- or very high-risk myelodysplastic syndrome, accelerated phase myeloproliferative neoplasm, MDS with excessive blasts, or chronic myelomonocytic leukemia-2, and acceptable lab results
You will not qualify if you...
- Persistent toxicity from previous AdvSM therapy not resolved to Grade 1 or less
- Associated hematologic neoplasm requiring immediate antineoplastic therapy
- Clinically significant cardiac disease
- Known positivity for FIP1L1 PDGFRA fusion mutation
- Positive for HIV 1 or 2, hepatitis B surface antigen, or hepatitis C antibody
- Clinically significant bleeding event within 30 days before first dose or need for therapeutic anticoagulation during study
- Diagnosed with or treated for other malignancy within 3 years before enrollment
- Received cytoreductive therapy or investigational agents less than 14 days before screening (28 days for certain therapies)
- Received hematopoietic growth factor support within 14 days before first dose
- Received strong CYP3A4 inhibitors or inducers within 14 days or 5 half-lives before first dose
- Need for treatment with high dose steroids
- For Substudy: diagnosis of Philadelphia chromosome-positive malignancy or acute myeloid leukemia
- Appropriate for allogenic hematopoietic stem cell transplantation
- Contraindications to selected concomitant therapy
- Rollover Cohort: unacceptable tolerability of previous bezuclastinib therapy
- High-Risk Cohort: prior investigational therapy for AdvSM or discontinued cytoreductive therapy due to toxicity
- High-Risk Cohort: recent cytoreductive therapy or investigational agents prior to screening or archival bone marrow biopsy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 42 locations
1
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, United States, 35233
Active, Not Recruiting
2
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
3
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
4
UCLA Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
5
Stanford Cancer Institute
Stanford, California, United States, 94305
Actively Recruiting
6
Galiz Research
Hialeah, Florida, United States, 33016
Withdrawn
7
Winship Cancer Institute - Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
8
Rush University Medical Center
Chicago, Illinois, United States, 60612
Withdrawn
9
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
10
Columbia University Irving Medical Center
New York, New York, United States, 10032
Withdrawn
11
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44106
Active, Not Recruiting
12
MUSC Health University Medical Center
Charleston, South Carolina, United States, 29425
Actively Recruiting
13
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
14
Huntsman Cancer Institute - University of Utah Health
Salt Lake City, Utah, United States, 84112
Actively Recruiting
15
Nepean Hospital
Kingswood, New South Wales, Australia, 2747
Actively Recruiting
16
Gold Coast University Hospital
Southport, Queensland, Australia, 4215
Actively Recruiting
17
Peter MacCallum Cancer Centre
Melbourne N., Victoria, Australia, 3051
Actively Recruiting
18
AKH Wien, Universitatsklinikum
Vienna, Austria, 1090
Active, Not Recruiting
19
CHU de Liege
Liège, Belgium, 4000
Withdrawn
20
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2G3
Actively Recruiting
21
St. Michael's Hospital - Unity Health Toronto
Toronto, Ontario, Canada, M5B 1W8
Actively Recruiting
22
Necker-Enfants Malades Hospital
Paris, France, 75015
Active, Not Recruiting
23
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, France, 86000
Active, Not Recruiting
24
Centre Hospitalier Universitaire (CHU) de Toulouse
Toulouse, France, 31300
Active, Not Recruiting
25
University Hospital Aachen
Aachen, Germany, 52074
Active, Not Recruiting
26
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, 79104
Active, Not Recruiting
27
UKSH Campus Lubeck
Lübeck, Germany, 23562
Active, Not Recruiting
28
Universitätsklinikum Mannheim
Mannheim, Germany, 68167
Active, Not Recruiting
29
IRCCS Azienda Ospedaliero Universitaria di Bologna
Bologna, Italy, 40138
Active, Not Recruiting
30
Azienda Ospedaliero Universitaria Careggi
Florence, Italy, 50134
Active, Not Recruiting
31
AOU San Giovanni di Dio e Ruggi dAragonia
Salerno, Italy, 84131
Active, Not Recruiting
32
Azienda Ospidaleira Universitaria Integrata Verona
Verona, Italy, 37124
Withdrawn
33
University Medical Center Groningen
Groningen, Netherlands, 9713
Active, Not Recruiting
34
Oslo University Hospital
Oslo, Norway, 0450
Active, Not Recruiting
35
Public University Hospital No. 1 in Lublin
Lublin, Poland, 20-400
Active, Not Recruiting
36
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08740
Active, Not Recruiting
37
Institut Català d'Oncologia - Hospital Duran i Reynals
Barcelona, Spain, 08908
Active, Not Recruiting
38
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Active, Not Recruiting
39
Universitätsspital Basel
Basel, Switzerland, 4031
Actively Recruiting
40
Guy's Hospital - NHS Foundation Trust
London, London, United Kingdom, SE1 9RT
Actively Recruiting
41
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
42
University College London Hospital - NHS Foundation Trust
London, United Kingdom, NW1 2BU
Actively Recruiting
Research Team
C
Cogent Biosciences, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here