(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the 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).
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Diagnoza jednej z zaawansowanych postaci mastocytozy układowej: ostra, z towarzyszącymi nowotworami krwi lub białaczka z komórek tucznych.
- •Choroba dająca się zmierzyć.
- •Stan ogólny pozwalający na udział w badaniu (skala ECOG od 0 do 3).
- •Wyniki podstawowych badań krwi i moczu w normie lub w akceptowalnych granicach.
✗ Disqualifies
- •Uporczywe skutki uboczne po poprzednim leczeniu, które nie ustąpiły do łagodnego stopnia.
- •Potrzeba natychmiastowego leczenia z powodu towarzyszącego nowotworu krwi.
- •Znaczne problemy z sercem.
- •Potwierdzona mutacja FIP1L1 PDGFRA. Osoby z podwyższoną liczbą eozynofili, bez mutacji KIT D816V, muszą mieć wykluczoną mutację PDGFRA przed rozpoczęciem badania.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 31, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (42)
University of Alabama at Birmingham (UAB) Hospital
Birmingham, United States
Mayo Clinic Arizona
Phoenix, United States
City of Hope Comprehensive Cancer Center
Duarte, United States
UCLA Medical Center
Los Angeles, United States
Stanford Cancer Institute
Stanford, United States
Galiz Research
Hialeah, United States
Winship Cancer Institute - Emory University
Atlanta, United States
Rush University Medical Center
Chicago, United States
Dana-Farber Cancer Institute
Boston, United States
Columbia University Irving Medical Center
New York, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, United States
MUSC Health University Medical Center
Charleston, United States
The University of Texas MD Anderson Cancer Center
Houston, United States
Huntsman Cancer Institute - University of Utah Health
Salt Lake City, United States
Nepean Hospital
Kingswood, Australia
Gold Coast University Hospital
Southport, Australia
Peter MacCallum Cancer Centre
Melbourne N., Australia
AKH Wien, Universitatsklinikum
Vienna, Austria
CHU de Liege
Liège, Belgium
University of Alberta Hospital
Edmonton, Canada
St. Michael's Hospital - Unity Health Toronto
Toronto, Canada
Necker-Enfants Malades Hospital
Paris, France
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, France
Centre Hospitalier Universitaire (CHU) de Toulouse
Toulouse, France
University Hospital Aachen
Aachen, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
UKSH Campus Lubeck
Lübeck, Germany
Universitätsklinikum Mannheim
Mannheim, Germany
IRCCS Azienda Ospedaliero Universitaria di Bologna
Bologna, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
AOU San Giovanni di Dio e Ruggi dAragonia
Salerno, Italy
Azienda Ospidaleira Universitaria Integrata Verona
Verona, Italy
University Medical Center Groningen
Groningen, Netherlands
Oslo University Hospital
Oslo, Norway
Public University Hospital No. 1 in Lublin
Lublin, Poland
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Institut Català d'Oncologia - Hospital Duran i Reynals
Barcelona, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Universitätsspital Basel
Basel, Switzerland
Guy's Hospital - NHS Foundation Trust
London, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
University College London Hospital - NHS Foundation Trust
London, United Kingdom
Trial contact
Cogent Biosciences, Inc.
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/1/2026.
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