The purpose of this expanded access program (EAP) protocol is to provide investigationalbezuclastinib to patients with a diagnosis of nonadvanced systemic mastocytosis(NonAdvSM) or advanced systemic mastocytosis (AdvSM) who have received and failed or beenintolerant to at least one standard approved therapy and/or have no comparable orsatisfactory alternative therapy options.
Not Provided
Drug: Bezuclastinib
Drug: Bezuclastinib Tablets
Other Name: CGT9486
Key Inclusion Criteria:
- Able to provide written informed consent and commit to EAP assessments.
- ≥18 years of age.
- Able to swallow tablets.
- Diagnosed with ASM, SM-AHN, MCL, BMM, ISM, or SSM according to the 2022 WHO
Classification for SM
- Not receiving adequate disease control on current therapy(ies).
- Have clinically acceptable laboratory screening results.
Exclusion Criteria:
- Patients who are eligible for and/or enrolled in an on-going bezuclastinib clinical
trial.
- Patients who discontinued investigational use of bezuclastinib in previous clinical
trials due to toxicity or withdrawal of consent.
- Pregnant or currently breastfeeding.
- Prior or ongoing clinically significant illness or medical or physical condition
Other protocol-defined criteria apply.
Orso Health/Modena Asthma Allergy
La Jolla, California, United States
Scripps Green Hospital
La Jolla, California, United States
UCLA Ronald Reagan Medical Center
Los Angeles, California, United States
Sneeze Wheeze & Itch Associates LLC Clinical Research Center
Normal, Illinois, United States
Indiana University Health
Indianapolis, Indiana, United States
Walter Reed
Bethesda, Maryland, United States
AllerVie Health
Glenn Dale, Maryland, United States
Boston Specialists
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Michigan Medicine- University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke Blood Cancer Center
Durham, North Carolina, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
AIR Care
Dallas, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
Alexandra Malinowski, PharmD
1-877-633-8049
EAP@cogentbio.com
Rachael Easton, MD, PhD, Study Director
Cogent Biosciences, Inc.