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Study of CGT9486 and Sunitinib for Patients with Advanced Gastrointestinal Stromal Tumors

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer known as gastrointestinal stromal tumors (GIST). These tumors occur in the digestive tract and can be challenging to treat, especially when they are advanced or have spread to other parts of the body. The study is comparing two treatments: a combination of two medications, CGT9486 and Sunitinib, against Sunitinib alone. CGT9486 is a new medication that works by blocking certain proteins that help cancer cells grow, while Sunitinib is an existing treatment that also targets cancer cell growth.

The purpose of this study is to determine how effective the combination of CGT9486 and Sunitinib is compared to Sunitinib alone in treating patients with GIST. Participants in the study will be randomly assigned to receive either the combination treatment or Sunitinib by itself. The study will monitor the progress of the disease and any side effects over a period of time to see which treatment works better.

Participants will take the medications orally, meaning they will swallow them in the form of tablets or capsules. The study will last for a maximum of 34 weeks, during which time the health and progress of the participants will be closely monitored by the research team. The goal is to find out if the new combination treatment can help control the disease more effectively than the current standard treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be randomly assigned to one of two groups. One group will receive a combination of CGT9486 and sunitinib, while the other group will receive sunitinib alone. This process is called randomization and ensures that the study results are unbiased.

  2. Step 2

    Medication administration

    If you are in the group receiving the combination treatment, you will take CGT9486 and sunitinib orally in the form of tablets. The specific dosage and frequency will be provided by the study team.

    If you are in the group receiving sunitinib alone, you will take it orally in the form of tablets. The specific dosage and frequency will be provided by the study team.

  3. Step 3

    Regular health assessments

    Throughout the study, you will undergo regular health assessments. These assessments are designed to monitor your health and the effects of the medication. They may include physical exams, blood tests, and imaging tests to evaluate the size and progression of the tumor.

  4. Step 4

    Reporting side effects

    It is important to report any side effects or changes in your health to the study team. This information helps ensure your safety and contributes to the understanding of the medication's effects.

  5. Step 5

    End of study participation

    Your participation in the study will continue until the study's estimated end date or until you decide to withdraw. The study team will provide guidance on any follow-up care or additional steps needed after your participation ends.

Who can join the trial?

10 criteria

  • Must have a gastrointestinal stromal tumor (GIST) that is locally advanced, has spread to other parts of the body (metastatic), or cannot be removed by surgery (unresectable). A report confirming this must be available. If not, a sample of the tumor will be needed to check its genetic makeup before joining the study.
  • Must have shown that the disease has gotten worse despite treatment with a drug called imatinib, or must be unable to tolerate imatinib due to side effects that cannot be managed by changing the dose.
  • Must have received the following treatments:
    • For Part 1a: At least one previous treatment for GIST.
    • For Part 1b: At least two previous treatments with a type of drug called TKI (Tyrosine Kinase Inhibitor) for GIST. Each different TKI counts once, even if used multiple times. If two different TKIs were used together, both are counted.
    • For Part 2: Previous treatment with imatinib only.
    • Must have at least one tumor that can be measured according to specific guidelines (mRECIST v1.1). Non-lymph node tumors must be at least 1.0 cm in size or at least twice the thickness of the imaging slice.
    • Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2, which is a scale used to assess how the disease affects daily living abilities. A score of 0 means fully active, while 2 means capable of all self-care but unable to carry out any work activities.
    • Other specific criteria defined in the study protocol may apply.
    • Both males and females can participate.
    • Participants must be within the age range specified by the study.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of cancer than a gastrointestinal stromal tumor cannot participate. A gastrointestinal stromal tumor is a type of tumor that occurs in the digestive tract.
  • Patients who are not within the specified age range cannot participate. The age range for this study is from 18 to 65 years old.
  • Patients who are unable to understand or follow the study procedures cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have any other serious medical conditions that might interfere with the study cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had an allergic reaction to the study drugs or similar drugs cannot participate.
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Investigated drugs

  • CGT9486

    is an experimental medication being tested in this clinical trial. It is designed to help treat gastrointestinal stromal tumors, which are a type of cancer that occurs in the digestive tract. The goal of this medication is to stop or slow down the growth of cancer cells, making it easier to manage the disease.

  • Sunitinib

    is a medication that is already used to treat certain types of cancer, including gastrointestinal stromal tumors. It works by blocking the action of certain proteins that promote the growth of cancer cells. By doing this, sunitinib can help to slow down or stop the progression of the cancer.

  • Bezuclastinib

    is another experimental medication being studied in this trial. Like CGT9486, it is aimed at treating gastrointestinal stromal tumors. Bezuclastinib is intended to work by targeting specific pathways in the cancer cells, potentially stopping them from growing and spreading.

What is already known about the treatment

  • Bezuclastinib

    Bezuclastinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating gastrointestinal stromal tumors (GIST). It is not yet widely used in medicine, as it is still under investigation. The main therapeutic indication for bezuclastinib is for patients with locally advanced, unresectable, or metastatic GIST. At the molecular level, bezuclastinib works by inhibiting specific proteins that promote tumor growth, helping to slow down or stop the progression of the cancer. It is classified as a tyrosine kinase inhibitor, a type of drug that blocks certain enzymes involved in cancer cell growth.

  • Sunitinib

    Sunitinib is an oral medication that is already approved and used in the treatment of various cancers, including gastrointestinal stromal tumors (GIST). It is commonly prescribed for patients with advanced or metastatic GIST. Sunitinib works by blocking multiple proteins that are involved in the growth and spread of cancer cells, effectively slowing down the disease. It belongs to the pharmacological class of tyrosine kinase inhibitors, which are drugs designed to interfere with specific enzymes that cancer cells need to grow.

Investigated diseases

Gastrointestinal stromal tumor – Gastrointestinal stromal tumor (GIST) is a type of tumor that occurs in the digestive tract, most commonly in the stomach or small intestine. It originates from special cells in the wall of the gastrointestinal tract known as interstitial cells of Cajal, which are part of the autonomic nervous system and help regulate digestive processes. GISTs can vary in size and may grow slowly or more rapidly, depending on their specific characteristics. As they progress, these tumors can cause symptoms such as abdominal pain, bleeding, or obstruction, depending on their location and size. They may also spread to other parts of the body, such as the liver or the lining of the abdominal cavity. The progression of GISTs is influenced by various factors, including genetic mutations and the biological behavior of the tumor cells.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500637-80-00Protocol codeCGT9486-21-301Estimated enrolment389 patientsSponsorCogent Biosciences Inc.

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