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 5363943, California 5332921, United States
Indiana University Health
Indianapolis 4259418, Indiana 4921868, United States
Walter Reed
Bethesda 4348599, Maryland 4361885, United States
AllerVie Health
Glenn Dale 4356289, Maryland 4361885, United States
Dana Farber Cancer Institute
Boston 4930956, Massachusetts 6254926, United States
Dartmouth-Hitchcock Medical Center
Lebanon 5088597, New Hampshire 5090174, United States
Duke Blood Cancer Center
Durham 4464368, North Carolina 4482348, United States
The Ohio State University Wexner Medical Center
Columbus 4509177, Ohio 5165418, United States
AIR Care
Dallas 4684888, Texas 4736286, United States
Alexandra Malinowski, PharmD
1-877-633-8049
medinfo@cogentbio.com
Rachael Easton, MD, PhD, Study Director
Cogent Biosciences, Inc.