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RecruitingPHASE1INTERVENTIONAL

A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tumors

This research study is looking at a new medicine called GSK5764227 for people with advanced solid tumours, which are cancers that have grown or spread. This new medicine is designed to deliver a 'toxic' substance directly to the cancer cells to kill them, while trying to avoid harming healthy cells. Researchers are combining GSK5764227 with standard treatments, like chemotherapy drugs (e.g., Bevacizumab, Fluorouracil) or hormone therapy (Enzalutamide), to see how well they work together. The main goals are to find out if the new medicine is safe, how the body handles it, whether it causes any immune reactions, and if it can help to shrink or control the cancer. This is an early-stage study (Phase 1), meaning it's one of the first times this medicine is being tested in humans.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
GlaxoSmithKline
Enrolment target
83
Start
03 Dec 2025
Estimated completion
01 May 2030

What is this study about?

This clinical trial is designed to investigate a new experimental medicine, known as GSK5764227. It's being developed for people who have advanced solid tumours, which are cancers that have either spread or are difficult to treat with surgery. The new medicine is quite clever – it's designed to act like a 'guided missile', delivering a substance that can kill cancer cells directly to them, while aiming to leave healthy cells unharmed. This could be a new way to fight cancer.

In this study, researchers are giving GSK5764227 alongside treatments that are already commonly used for cancer, such as certain chemotherapy drugs (like Bevacizumab or Fluorouracil) or hormone therapy (like Enzalutamide). By combining the new medicine with existing ones, the team wants to see if they can work better together. They are particularly interested in understanding how safe this new combination is, how the body processes the new medicine, and if it triggers any immune responses. Importantly, they also want to see if these treatments can help to shrink the tumours or stop them from growing.

This is an early-stage study, called a Phase 1 trial. This means it's one of the first times the new medicine is being tested in people. The main aim of a Phase 1 trial is to check the safety of the medicine and find the right dose. While it's early days, this research is crucial for understanding if this new approach could one day become a standard treatment option for people with advanced solid tumours.

Key takeaways

  • This study is testing a new cancer medicine (GSK5764227) for advanced solid tumours.
  • The new medicine aims to specifically target and kill cancer cells.
  • It's being combined with standard cancer treatments to see if they work better together.
  • This is an early-stage study (Phase 1) focused on safety and finding the right dose.
  • Participants will receive the study medicines and have regular health checks.
  • There are specific health requirements to join, including having certain types of advanced cancer.

Who may be eligible?

To be considered for this study, you would need to be 18 years old or older. Generally, you should be well enough to carry out most of your daily activities without much help, meaning you're quite active. Your body's organs, such as your liver and kidneys, need to be working properly. The type of cancer you have is important too. For some parts of the study, you would need to have advanced bowel or rectal cancer (called adenocarcinoma) that doctors can't remove with surgery. For other parts, you would need to have advanced prostate cancer (also adenocarcinoma) that has been confirmed by a biopsy.

There are also some reasons why you might not be able to join. For example, if you've had another type of cancer that needed treatment in the last two years, you might not be suitable, unless it was a very early skin cancer or a cancer that was completely removed and hasn't returned (like certain breast or bladder cancers). You also can't have had a major operation in the last month, or a serious infection in the last four weeks. If you have significant bleeding problems, untreated or growing brain tumours, or a certain type of lung problem (like severe scarring or inflammation), you might not be able to take part.

Furthermore, if you've had certain autoimmune diseases that needed strong medication in the last two years, or if you're taking medicines that suppress your immune system (unless it's a very low dose of steroids), you wouldn't be able to join. These rules are in place to help keep you safe and to make sure the study results are clear.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Are you generally well enough to do your daily activities?
  3. Do you have advanced bowel, rectal, or prostate cancer that fits the study criteria?
  4. Have you *not* had major surgery in the last month?
  5. Do you *not* have significant untreated brain tumours or certain serious lung conditions?
  6. Are you *not* currently taking strong medicines to suppress your immune system (unless it's a very low steroid dose)?
Answer every question to see your result.

What does participation involve?

Taking part in this study means you would be given the new medicine, GSK5764227, in combination with other standard cancer treatments. This would likely involve regular visits to the hospital or clinic for your treatments and to have various checks and tests done. These tests might include blood tests, scans (like CT or MRI scans) to see how your cancer is responding, and possibly other procedures to monitor your health.

The specific number of visits and the total duration of your participation would depend on how you respond to the treatment and the stage of the study. You would receive the study medication as prescribed by the research team. Throughout the study, the doctors and nurses would keep a close eye on your health and any side effects you might experience. After your treatment phase, there would typically be a follow-up period to continue monitoring your health, even if you stop taking the study medication. All these details would be fully explained to you before you decide whether to join.

Potential risks and benefits

Like all medicines, the treatments in this study have potential benefits and risks. You might benefit if the new combination of medicines helps to shrink your tumour or control your cancer for longer than existing treatments. However, there's no guarantee that you will personally benefit from taking part. You might experience side effects, some of which could be serious, from either the new medicine or the standard treatments, or from their combination. The research team will monitor you closely for any side effects and will explain all known risks to you. Remember, taking part in any clinical trial is entirely your choice, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (22)

  • GSK Investigational Site
    Verified postcode
    Reunion, United States· Recruiting
  • GSK Investigational Site
    Verified postcode
    New Hyde Park, United States· Recruiting
  • GSK Investigational Site
    Verified postcode
    Philadelphia, United States· Recruiting
  • GSK Investigational Site
    Verified postcode
    Nashville, United States· Recruiting
  • GSK Investigational Site
    Verified postcode
    Dallas, United States· Recruiting
  • GSK Investigational Site
    Verified postcode
    Douglas, Australia· Recruiting
  • GSK Investigational Site
    Verified postcode
    Tugun, Australia· Recruiting
  • GSK Investigational Site
    Verified postcode
    Geelong, Australia· Recruiting
  • GSK Investigational Site
    Verified postcode
    Bendigo, Australia· Recruiting
  • GSK Investigational Site
    Verified postcode
    Ottawa, Canada· Recruiting
  • GSK Investigational Site
    Verified postcode
    Toronto, Canada· Recruiting
  • GSK Investigational Site
    Verified postcode
    Seoul, South Korea· Recruiting

Common questions

What is GSK5764227?

It's a new experimental medicine being tested to treat advanced cancers. It's designed to deliver a cancer-killing substance directly to tumour cells.

Why combine it with other treatments?

Researchers want to see if combining the new medicine with existing cancer treatments can make them more effective against cancer.

Is this a new type of treatment?

Yes, this medicine works by targeting cancer cells specifically to deliver a toxin, which is a different approach for some advanced cancers.

What phase is this trial?

This is a Phase 1 study, which is an early stage of testing new medicines in humans to primarily check for safety and find the right dose.

Can I still have my regular cancer treatment if I join?

Yes, in this study, the new medicine is given alongside certain standard cancer treatments, which would be part of your study plan.

How to find out more

US GSK Clinical Trials Call Center

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study of GSK5764227 in Combination With Standard of Care (…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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