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

1 1 1

What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Netherlands Cancer Institute Amsterdam The Netherlands
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Helse Stavanger HF Stavanger Norway
Algemeen Ziekenhuis Delta Roeselare Belgium
Katholisches Klinikum Bochum gGmbH Bochum Germany
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Brzozow Poland
Europejskie Centrum Zdrowia Otwock Sp. z o.o. Otwock Poland
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Region Skane Skanes Universitetssjukhus Lund Sweden
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Karolinska University Hospital Solna Sweden
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw Poland
Centre Hospitalier Universitaire De Nantes Nantes France
Muenchen Klinik gGmbH Munich Germany
Pohjois-Savon hyvinvointialue Kuopio Finland
Pirkanmaan hyvinvointialue Tampere Finland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Hopital Beaujon Clichy France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Soedersjukhuset AB Stockholm Sweden
Cvomehslr Ujjxcjsgbxhlay Shwrzycru Woluwe-Saint-Lambert Belgium
Hsyddcuy Ugcinjlrcaqda Mbimqzt Dg Vlvdoouknz Santander Spain
Itkqvt Bonheiden Belgium
Dghyppqr Oo Helsinki Finland
Luggzjxb Olqddassxrdx Ssznbfpmlsxwufklu Luebeck Germany
Cuhxxb Hcryequvvqg Uxlssiytdiywa Dl Dolag Dijon France
Aeatjqdr Ugzkgullkb Hcsprukn Lorenskog Norway
Udapgmq Usbjfjxwbd Hbhrqhlz Uppsala Sweden
Hxwsfhbi Uslocmpllm Cholomz Hrqfnqoe Helsinki Finland
Ejjcsjq Urtnjlcxpscm Muumolv Cdupina Rlsjfhdip (uumiugn Mkc Rotterdam The Netherlands
Nlimxrym Iythfoxk Ocvdbjhzd Iql Mrjol Saicnlhjhonqiigstvfwrpufehpe Iizcddek Bmlpulnv Cracow Poland
Hfjyujpz Do Lk Sdydo Cbrk I Sjzp Pix Barcelona Spain
Hxqxxqko Vciq dcngsrfj Barcelona Spain
Ulgnlgjfzqmgboebxbhbj Dnxasjowdei Aml Duesseldorf Germany
Iyyoelyb Pzyittpktdtdqlc Csfvcd Cyomtk Marseille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
15.08.2025
Finland Finland
Recruiting
15.08.2025
France France
Recruiting
15.08.2025
Germany Germany
Recruiting
15.08.2025
Italy Italy
Recruiting
15.08.2025
Norway Norway
Recruiting
15.08.2025
Poland Poland
Recruiting
15.08.2025
Spain Spain
Recruiting
15.08.2025
Sweden Sweden
Recruiting
15.08.2025
The Netherlands The Netherlands
Recruiting
15.08.2025

Trial locations

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.

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 ID:
2025-520672-26-00
Protocol code:
223675
NCT ID:
NCT06885034
Trial Phase:
Human Pharmacology (Phase I) – Other

Other Trials to Consider

  • Study on the Impact of Cisplatin and Drug Combination on Speech and Cognition in Cancer Patients

    Recruiting

    3 1 1 1
    Investigated diseases:
    Finland
  • Study on the Effectiveness and Safety of BAY 2927088 for Patients with Advanced Solid Tumors with HER2 Mutations

    Recruiting

    2 1 1
    Denmark France Italy Spain