About this trial
The SUMMIT trial is designed to find out whether bezuclastinib (CGT9486) can safely and effectively reduce symptoms and improve quality of life for people with non‑advanced systemic mastocytosis — specifically indolent, smoldering, or bone‑marrow forms — whose symptoms are not adequately controlled with standard supportive treatments.
It compares bezuclastinib plus best supportive care to placebo plus best supportive care, using a randomized, double‑blind design to measure improvements in symptom burden, safety, and overall disease control. A substudy also evaluates bezuclastinib in patients whose symptoms remain uncontrolled despite treatment with avapritinib
Patient Profile
The trial is for adults with non‑advanced systemic mastocytosis — indolent, smoldering, or bone‑marrow subtypes — whose symptoms remain troublesome despite standard supportive treatments. It also includes a small group of patients whose symptoms are still not controlled even after trying avapritinib.
Where’s this trial being run?
Cork University Hospital and St James’s Hospital
Can I join this study / trial?
The first step we recommend is to talk to your doctor or the cancer trials team at your hospital. You can find contact details for cancer trials research units in Ireland here.
It’s also a good idea to print this page and bring it with you to your appointment. It can help guide the conversation and remind you of what to ask. You may also want to talk to your family or friends about your options, as they can offer support as you make decisions.
For more detailed information
Click HereQuestions?
Here’s a list of questions you may have for your doctor or local cancer research team.
QuestionsSummary Data
| Name: | SUMMIT |
|---|---|
| Number: | 24-104 |
| Full Title: | A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis |
| Principal Investigator: | Dr Clodagh Keohane |
|---|---|
| Type: | Industry Sponsored |
| Sponsor: | Cogent Biosciences |
| Recruitment Started: |
Global: June 2022 Ireland: |
| Global Recruitment Target: | 138 |
|---|---|
| Ireland Recruitment Target: |