Testing GSK5764227 combined with standard cancer treatments in patients with advanced solid tumors to evaluate safety and effectiveness

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What is this study about?

This study is looking at advanced solid tumors, which are cancers that have spread or cannot be removed with surgery. The study includes two specific types of cancer. The first is colorectal cancer, which is cancer that starts in the colon or rectum, the lower parts of the digestive system. The second is metastatic castration-resistant prostate cancer, which is prostate cancer that has spread to other parts of the body and continues to grow even when treatments to lower testosterone levels are used. The study will test a new medicine called GSK5764227, which will be given in combination with other standard treatments. For colorectal cancer, these standard treatments include bevacizumab, a medicine that blocks blood vessel growth in tumors, and fluorouracil with folinic acid, which are chemotherapy medicines that work together to stop cancer cells from growing. For prostate cancer, the standard treatment includes enzalutamide, a medicine that blocks male hormones that help cancer grow.

The purpose of this study is to find out the best dose of GSK5764227 that can be given safely with these standard treatments and to see how well it works in treating these cancers. The study will also check what side effects occur and how the body processes the medicine. During the study, patients will receive GSK5764227 through a vein along with their standard treatment medicines. Some medicines will be given through a vein while others are taken by mouth as tablets. Doctors will regularly check patients through physical exams, blood tests, and scans to see how the cancer is responding to treatment and to monitor for any side effects. Blood samples will also be collected to measure the levels of the study medicine in the body and to look for any immune responses to it.

Throughout the study, doctors will measure several things to understand how well the treatment works. They will look at how many patients have their tumors shrink or disappear, how long the cancer stays under control, and how long patients live without their cancer getting worse. For prostate cancer patients, doctors will also measure levels of a substance called PSA in the blood, which is a marker that helps track prostate cancer. The study will also carefully track any side effects or health changes that occur during treatment to understand the safety of this combination of medicines.

1 Initial assessment and baseline evaluation

Your general health status will be evaluated using a performance score that measures your ability to carry out daily activities. This score ranges from 0 (fully active) to 1 (restricted in physically strenuous activity but able to carry out light work).

Your organ function will be assessed through laboratory tests including blood tests for blood cell counts, liver function, kidney function, and urine analysis.

Your heart function will be checked using an electrocardiogram.

Your vital signs including blood pressure, heart rate, and body weight will be measured.

If you have colorectal cancer, at least one tumor that can be measured will be identified using imaging scans according to standard tumor measurement criteria.

If you have prostate cancer, your prostate-specific antigen level (a protein produced by the prostate) will be measured and must be at least 1 nanogram per milliliter. Your testosterone level (a hormone) will also be checked and must be at a low level. You must have at least one tumor in soft tissue that can be measured or at least one tumor in the bone visible on bone scans.

A tissue sample from your tumor will be required. This can be from a previous biopsy stored as a tissue block or slides. If you have colorectal cancer, a fresh biopsy is preferred if possible. This tissue will be analyzed to understand specific characteristics of your tumor.

2 Treatment with study medication and standard therapies

You will receive GSK5764227, which is the investigational medication being studied. This medication will be given through a vein (intravenously). The dose and schedule will be determined based on safety findings in the study.

If you have colorectal cancer, you will also receive standard chemotherapy medications: fluorouracil (also called 5-FU) given through a vein, folinic acid (also called leucovorin) given through a vein, and bevacizumab given through a vein. These medications help stop cancer cells from growing and dividing.

If you have prostate cancer, you will also receive enzalutamide, which is a tablet taken by mouth at a dose of 40 milligrams. This medication blocks hormones that help prostate cancer grow.

If you have prostate cancer, you will continue your ongoing hormone therapy that lowers testosterone levels throughout the study.

The combination of medications will be given in treatment cycles. The exact duration and frequency of each medication will be determined by the study protocol.

3 Regular monitoring visits during treatment

You will have regular visits to monitor your response to treatment and check for any side effects.

At each visit, your vital signs and body weight will be measured.

Blood samples will be collected regularly to check your blood cell counts, liver function, kidney function, and to measure drug levels in your blood.

If you have prostate cancer, your prostate-specific antigen levels will be measured regularly to assess treatment response.

Your heart function will be monitored periodically with electrocardiograms.

Imaging scans will be performed at scheduled intervals to measure changes in your tumors.

Your ability to carry out daily activities will be assessed at each visit.

Any side effects or health changes you experience will be recorded and evaluated according to standardized toxicity criteria.

4 Assessment of treatment response

Your tumor response will be evaluated using imaging scans performed at regular intervals.

If you have colorectal cancer, tumor measurements will follow standard solid tumor response criteria to determine if tumors have shrunk, remained stable, or grown.

If you have prostate cancer, tumor response will be assessed using specific criteria for prostate cancer that evaluate soft tissue tumors, bone tumors, and prostate-specific antigen levels.

The assessment will determine if you have achieved a complete response (all tumors disappeared), partial response (tumors shrunk significantly), stable disease (tumors neither grew nor shrunk significantly), or progressive disease (tumors grew or new tumors appeared).

Blood samples will be collected to test for antibodies your body may develop against the study medication.

5 Continuation or discontinuation of treatment

You will continue receiving treatment as long as your cancer does not worsen, you do not experience unacceptable side effects, and you choose to remain in the study.

If your cancer progresses, if side effects become too severe, or if you decide to stop treatment, your participation in the treatment phase will end.

The time from when you start treatment until your cancer worsens or you pass away will be tracked.

If your tumors respond to treatment, the duration of that response will be measured from the first documentation of response until the cancer worsens or you pass away.

6 End of treatment evaluation

When you stop receiving study treatment, a final evaluation will be performed.

This will include physical examination, vital signs, blood tests, heart function assessment, and imaging scans.

Any ongoing side effects will be documented.

Information about why treatment ended will be recorded.

7 Follow-up after treatment ends

After you stop treatment, you will be followed to monitor your health status and cancer progression.

Information about any subsequent cancer treatments you receive will be collected.

Your survival status will be tracked.

The study is expected to continue collecting information until approximately January 2028.

Who Can Join the Study?

You must be at least 18 years old or the legal age to give consent in your area at the time of signing the consent form
You must have adequate organ function, which means your major organs like liver, kidneys, and bone marrow are working well enough
You must have an ECOG performance status of 0 or 1, which is a score that measures how well you can carry out daily activities, with no worsening in the 2 weeks before starting treatment
For patients with colorectal cancer: You must have cancer of the colon or rectum that has been confirmed by examining tissue under a microscope, and the cancer cannot be removed by surgery or has spread to other parts of the body
For patients with colorectal cancer: You must have received at least 1 but no more than 2 previous treatment plans for advanced disease, and your cancer must have gotten worse on your most recent treatment
For patients with colorectal cancer: Your previous treatments must have included certain chemotherapy drugs and specific antibody treatments if they are available in your area
For patients with colorectal cancer: You must have at least one tumor that can be measured on imaging scans
For patients with colorectal cancer: You must provide a tissue sample from a biopsy of your cancer, preferably a fresh sample or a stored sample from your most recent biopsy
For patients with prostate cancer: You must have cancer of the prostate that has been confirmed by examining tissue or cells under a microscope
For patients with prostate cancer: Your cancer must have spread to other parts of the body, but not only to lymph nodes in the pelvis or rectum
For patients with prostate cancer: Your PSA level, which is a blood test that measures a protein made by the prostate, must be at least 1 during screening
For patients with prostate cancer: Your testosterone level must be very low during screening. You must have had surgery to remove both testicles or be receiving continuous hormone therapy to lower testosterone, which must have started at least 4 weeks before joining the study
For patients with prostate cancer: Your cancer must have gotten worse despite hormone therapy or you could not tolerate previous standard treatments
For patients with prostate cancer: You must have cancer that has spread and includes either at least one tumor that can be measured on scans or at least one area of cancer in the bones
For patients with prostate cancer: You should provide a stored tissue sample from your most recent biopsy if available

Who Cannot Join the Study?

The study does not include children or adolescents under 18 years of age
The study does not include elderly adults over 64 years of age
Patients who are currently participating in another clinical trial, which means another research study testing new treatments
Patients whose cancer has spread to the brain or spinal cord, unless it has been successfully treated and is stable
Patients with serious heart problems or heart disease that is not well controlled
Patients with severe liver problems or liver function that is not working properly, which means the organ that cleans your blood is not healthy enough
Patients with severe kidney problems or kidney function that is not working properly, which means the organs that filter waste from your blood are not healthy enough
Patients with active infections that require treatment with antibiotics or other medicines
Patients who have received certain types of cancer treatment within a specific time period before joining the study
Patients with known allergies or severe reactions to the study medicine or similar medicines
Women who are pregnant or breastfeeding
Patients who are not willing to use effective birth control methods during the study if they can become pregnant or cause pregnancy
Patients with other serious medical conditions that could make it unsafe to participate in the study
Patients who have had major surgery within a certain time period before starting the study
Patients with blood clotting problems or who are taking blood thinning medicines that cannot be stopped

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Hhaoypmc Voin dbifhbpg	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	08.12.2025

Trial locations

Investigated drugs:

GSK5764227 is an investigational medication being tested in this clinical trial. It is being studied in combination with other treatments to see how safe it is and how well it works in people with advanced solid tumors, which are cancers that have spread or grown significantly.

Standard of Care treatments refers to the usual or commonly accepted treatments that doctors typically use for treating advanced solid tumors. These are established therapies that are already approved and regularly used in medical practice. In this trial, Standard of Care treatments will be given together with the investigational medication to see if the combination is safe and effective.

Investigated diseases:

Neoplasm

Neoplasms – Neoplasms are abnormal growths of tissue that occur when cells divide and grow more than they should or do not die when they should. These growths can develop in any part of the body and may be benign, meaning they do not spread to other parts of the body, or malignant, meaning they can invade nearby tissues and spread to other organs. Malignant neoplasms are commonly referred to as cancer. The growth occurs because of changes in the genes that control cell division and death. As neoplasms grow, they can interfere with the normal function of the affected organ or tissue. Advanced solid tumors refer to neoplasms that have grown large or spread to other parts of the body.

Trial ID:

2025-522274-37-00

Protocol code:

300148

Trial Phase:

Human Pharmacology (Phase I) – Other

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Testing GSK5764227 combined with standard cancer treatments in patients with advanced solid tumors to evaluate safety and effectiveness

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?