GIST is a rare cancer affecting the gastrointestinal (GI) tract. In most cases, GISTs arise in the stomach or small intestine, but can form anywhere along the digestive tract. GISTs are most often driven by genetic mutations in the KIT tyrosine kinase receptor gene.1
GIST can advance and spread to other parts of the body, including the lungs and bone.2
Progression of GIST varies widely depending on the location, size, and aggressiveness of the tumor.3
In addition to surgery, GIST is often treated with KIT/ PDGFR⍺ tyrosine kinase inhibitors such as imatinib and sunitinib.4
The Peak study is a Phase 3 clinical trial evaluating bezuclastinib in combination with sunitinib in people with imatinib-resistant GIST. Sunitinib is an approved tyrosine kinase inhibitor that is the standard of care for GIST patients after failure of or resistance to imatinib treatment, but does not work against all types of mutations that can occur in the KIT gene.5 Bezuclastinib is a tyrosine kinase inhibitor designed to selectively and potently target a specific range of KIT mutations, including some mutations that sunitinib does not work against. Cogent believes that when bezuclastinib and sunitinib are used in combination, they have the potential to provide coverage across the broad range of KIT mutations that occur in GIST. Eligible participants will be randomized (assigned) to receive sunitinib alone or a combination of bezuclastinib and sunitinib.*
* Patients who are randomized to receive sunitinib alone, and whose disease has progressed during the trial, may be able to cross over to receive bezuclastinib in combination with sunitinib. Learn more about the Peak trial at clinicaltrials.gov.
Used to determine eligibility
Tablets are taken orally daily following the schedule provided
Occur approximately monthly during trial participation
Bezuclastinib is an investigational therapy and has not been approved by the U.S. Food & Drug Administration (FDA) or any other healthcare authority for commercial use.
All clinical trials have a number of entry criteria that people must meet in order to participate. These are called inclusion and exclusion criteria and are related to a person’s health when they enter the clinical trial.
To find out if you are initially eligible for this clinical trial, take the pre-screener.See if you are eligible!
Below are some frequently asked questions about the Peak clinical trial:
If you or someone you know are interested in the Peak clinical trial for GIST, please feel free to share this email.
Cogent Biosciences, Inc. is a biotechnology company developing real solutions to treat genetically driven diseases. With a focus on the design of rational precision therapies, we are leveraging validated biology to address the true underlying drivers of disease and provide real hope for patients.
Millions of people around the world are living with a genetically defined disease. Mutations can create a ripple effect in the body to trigger illness – cancers, autoimmune conditions, and rare diseases. For most of these diseases, despite the available therapies, there still exists a significant unmet need to extend survival and improve the quality of life for patients.
Please explore our website to find out more.