Peak is a Phase 3 clinical trial evaluating bezuclastinib (CGT9486), a selective and potent KIT inhibitor, in combination with sunitinib vs. sunitinib alone, in people with locally advanced, unresectable, or metastatic Gastrointestinal Stromal Tumors (GIST) who have previously received imatinib.

What is a Gastrointestinal Stromal Tumor (GIST)?

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

About the Peak Clinical Trial

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

Screening Period

Used to determine eligibility

Dosing Period

Tablets are taken orally daily following the schedule provided

Health Assessments

Occur approximately monthly during trial participation

Follow-up period

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.

Are You Eligible?

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.

You may be eligible if you:

  • Are 18 years of age or older
  • Have histologically confirmed locally advanced, metastatic, and/or unresectable Gastrointestinal Stromal Tumor (GIST)
  • Have received prior treatment with imatinib only

You are not eligible if you:

  • Have a known PDGFR driving mutation or known SDH deficiency
  • Are pregnant or breastfeeding
  • Have received prior treatment other than imatinib

To find out if you are initially eligible for this clinical trial, take the pre-screener.

Have Questions about the Peak Clinical Trial?

Below are some frequently asked questions about the Peak clinical trial:

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About Cogent Biosciences

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.

Cogent Biosciences, Inc.

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