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Study of GSK5764227 alone and in combination for patients with previously treated advanced gastrointestinal tumors that cannot be removed by surgery or have spread

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This clinical study focuses on evaluating a new treatment for gastrointestinal neoplasms, which are cancers that develop in the digestive system. The study specifically looks at cases where the cancer is advanced and cannot be surgically removed (unresectable) or has spread to other parts of the body (metastatic). The investigational medication, called GSK5764227, will be tested both alone and in combination with other treatments.

The medication GSK5764227 is administered through intravenous infusion, which means it is given directly into a vein. The drug comes in the form of a powder that is converted into a solution before being administered. The main purpose of this research is to determine how well this new treatment works and how safe it is for patients who have already received previous treatments for their gastrointestinal cancer.

This is a combined Phase 1b/2 study, which means it will assess both the safety and effectiveness of the treatment. The study is "open-label," which means all participants will know which treatment they are receiving. Some participants will receive different doses of the medication to help determine which amount works best while maintaining safety. The study will include multiple medical centers to ensure a thorough evaluation of the treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive GSK5764227 through an intravenous infusion (delivered directly into your vein)

    The medication comes in the form of a powder that will be prepared as a solution for infusion

    Your doctor will evaluate your response to one of two different doses of the medication

  2. Step 2

    Monitoring and assessment

    Your doctor will monitor how your tumor responds to the treatment using imaging scans

    The response will be measured according to standardized criteria called RECIST 1.1, which tracks changes in tumor size

    Regular assessments will check if your cancer shows complete response (disappearance), partial response (shrinkage), or other changes

  3. Step 3

    Ongoing evaluations

    Your overall health and ability to perform daily activities will be regularly assessed

    Blood tests will be performed to monitor your organ function

    Imaging scans will continue to track any target lesions identified at the start of the study

  4. Step 4

    Study duration

    The study is scheduled to run from August 2025 to March 2028

    Your participation duration will depend on how your body responds to the treatment

    Regular follow-up visits will be scheduled throughout your participation period

Who can join the trial?

10 criteria

  • Must be at least 18 years old or of legal age to consent in your location
  • Must have confirmed advanced colon or rectal cancer that cannot be surgically removed or has spread to other parts of the body
  • Must have previously received 1-2 treatments for advanced colorectal cancer, including:
    • Fluoropyrimidine (a type of chemotherapy drug)
    • Oxaliplatin and/or irinotecan (chemotherapy drugs)
    • Anti-VEGF antibody and/or anti-EGFR antibody treatments (if available)
    • Must have at least one tumor that can be measured using special imaging criteria (RECIST 1.1)
    • Must be able to provide a tissue sample from either:
      • A new tumor biopsy
      • Previously stored tumor tissue
      • Must have good physical function (ECOG score of 0 or 1), with no worsening in the 2 weeks before starting the study
      • Must have normal functioning organs

Who cannot join the trial?

15 criteria

  • Prior treatment with any immune checkpoint inhibitor (drugs that help the immune system fight cancer)
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • History of autoimmune disease (condition where immune system attacks healthy cells)
  • Active or chronic infections including hepatitis B, hepatitis C, or HIV
  • Significant heart conditions or uncontrolled high blood pressure
  • Major surgery within 28 days before starting the study
  • Currently participating in another clinical trial
  • Pregnant or breastfeeding women
  • Known allergies to study medication components
  • Serious medical conditions that could interfere with study participation
  • Use of systemic steroids or other immunosuppressive medications
  • History of other cancers within the past 3 years (except for successfully treated non-melanoma skin cancer)
  • Inability to swallow oral medications
  • Significant abnormal laboratory test results
  • Mental conditions that could affect ability to provide informed consent
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Investigated drugs

GSK5764227 This is an investigational medication being studied for treating advanced gastrointestinal tumors and metastatic colorectal cancer (mCRC). It is being tested both as a standalone treatment and in combination with other therapies. The medication is still in early clinical trials (Phase 1b/2) to determine if it is safe and effective for patients who have previously received other treatments for their cancer.

What is already known about the treatment

GSK5764227 - An investigational medication currently being studied in clinical trials for the treatment of advanced gastrointestinal cancers, particularly metastatic colorectal cancer (mCRC). This drug is being evaluated in different dosage levels as both monotherapy and in combination therapy for patients who have previously received other treatments. While the exact mechanism of action has not been publicly disclosed in the available trial data, it is being investigated as a targeted therapy for solid tumors. The medication is part of a Phase 1b/2 clinical trial, indicating it is still in the experimental stage of development and not yet approved for general medical use.

Investigated diseases

Gastrointestinal Neoplasms – A group of cancers that develop in various parts of the digestive system, including the esophagus, stomach, small intestine, large intestine, rectum, and anus. These tumors begin when cells in the digestive tract start growing abnormally and form masses. The growth can start in different layers of the digestive tract tissues, such as the inner lining, muscle layer, or outer covering. Gastrointestinal neoplasms can range from benign tumors to malignant cancers, with different growth patterns and behaviors. They can spread locally within the digestive system or to other parts of the body through lymph nodes and blood vessels.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-520672-26-00Protocol code223675Estimated enrolment316 patientsSponsorGlaxosmithkline Research & Development Limited

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