BridgeMD
A Study to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Profiles of CGT9486 in subjects with Advanced Systemic Mastocytosis
EU CTIS ID: 2024-511407-42-00
What this study is testing
Part 1: To identify a clinically active and tolerable systemic exposure range of bezuclastinib in subjects with AdvSM. Part 2 Stage 1: To confirm the optimal dose of bezuclastinib in subjects with AdvSM. Part 2 Stage 2: To determine the efficacy of bezuclastinib at the selected optimal dose in subjects with AdvSM.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosed with 1 of the following advanced mastocytosis diagnoses: 1. Aggressive Systemic Mastocytosis (ASM) 2. Systemic Mastocytosis with an Associated Hematologic Neoplasm (SM-AHN) 3. Mast Cell Leukemia (MCL)
- Measurable disease according to modified IWG-MRT-ECNM criteria
- ECOG Status 0 to 3
- Have clinically acceptable laboratory screening results (clinical chemistry, hematology) within certain limits
- Other protocol-defined inclusion criteria apply.
You likely can't join if
- Persistent toxicity from previous therapy for Advanced Systemic Mastocytosis that has not resolved to ≤ Grade 1
- Received strong CYP3A4 inhibitors or inducers within 14 days or 5 drug half-lives, whichever is longer, before the first dose of study drug.
- Need for treatment with high dose steroids
- Associated hematologic neoplasm requiring immediate antineoplastic therapy
- Clinically significant cardiac disease
- Known positivity for the FIP1L1 PDGFRA fusion (patients with eosinophilia without detectable KIT D816V mutation must also lack the PDGFRA fusion mutation prior to enrolment)
See the full eligibility criteria
- Diagnosed with 1 of the following advanced mastocytosis diagnoses: 1. Aggressive Systemic Mastocytosis (ASM) 2. Systemic Mastocytosis with an Associated Hematologic Neoplasm (SM-AHN) 3. Mast Cell Leukemia (MCL)
- Measurable disease according to modified IWG-MRT-ECNM criteria
- ECOG Status 0 to 3
- Have clinically acceptable laboratory screening results (clinical chemistry, hematology) within certain limits
- Other protocol-defined inclusion criteria apply.
- Persistent toxicity from previous therapy for Advanced Systemic Mastocytosis that has not resolved to ≤ Grade 1
- Received strong CYP3A4 inhibitors or inducers within 14 days or 5 drug half-lives, whichever is longer, before the first dose of study drug.
- Need for treatment with high dose steroids
- Associated hematologic neoplasm requiring immediate antineoplastic therapy
- Clinically significant cardiac disease
- Known positivity for the FIP1L1 PDGFRA fusion (patients with eosinophilia without detectable KIT D816V mutation must also lack the PDGFRA fusion mutation prior to enrolment)
- Seropositive for human immunodeficiency virus (HIV) 1 or 2, positive for hepatitis B surface antigen, or positive for hepatitis C virus (HCV) antibody
- History of clinically significant bleeding event within 30 days before the first dose of study drug or need for therapeutic anticoagulation on study
- Diagnosed with or treated for malignancy other than the disease under study within the prior 3 years before enrollment
- Received any cytoreductive therapy or any investigational agent less than 14 days, and for cladribine, interferon alpha, pegylated interferon, and any antibody therapy less than 28 days, before screening bone marrow biopsy
- Received hematopoietic growth factor support within 14 days before the first dose of study drug.
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Switzerland
- Canada
- United Kingdom
- Australia
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Switzerland; Canada; United Kingdom; Australia; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.