RecruitingPHASE1, PHASE2INTERVENTIONAL

First-Time-in-Human Study of GSK5471713 in Adults With mCRPC

This research study is investigating a new medication called GSK5471713 for men who have prostate cancer that has spread to other parts of the body (mCRPC) and is no longer responding to standard hormone therapy. This is one of the first times this medicine is being tested in humans. The main goals of the study are to understand if GSK5471713 is safe to use, how well people tolerate it, and how the body handles the medicine. Researchers will also look for early signs that the medicine might be active against cancer. By carefully studying these things, the team hopes to learn about both the potential benefits and any risks involved with this new treatment for advanced prostate cancer.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

GlaxoSmithKline

Enrolment target

Start

10 Feb 2026

Estimated completion

26 Mar 2030

Neoplasms, Prostate

What is this study about?

This study is a very important early step in developing a new treatment for men with a specific type of prostate cancer. Prostate cancer can sometimes spread to other parts of the body, and this is known as metastatic prostate cancer. When it also stops responding to hormone treatments, it's called metastatic castration-resistant prostate cancer (mCRPC). For men in this situation, finding new and effective treatments is crucial.

The researchers are testing a new medicine called GSK5471713. Because this is one of the first times this medicine is being given to people, the study focuses on safety first and foremost. They want to make sure it's safe enough for patients, understand any side effects, and see how the body uses and processes the drug. They will also look for any early signs that the medicine might be helping to control the cancer.

By carefully gathering all this information, the study aims to determine if GSK5471713 has a good balance of potential benefits and risks. If the initial findings are positive, it could lead to further research and potentially a new treatment option for men with advanced prostate cancer in the future.

Key takeaways

This study is for men with advanced prostate cancer that has spread and is resistant to hormone treatment.
It's testing a new medicine, GSK5471713, for the first time in humans to check its safety and effects.
Participants must have had previous hormone therapy and 1-2 types of chemotherapy.
Close medical monitoring will be provided throughout the study.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adult men aged 18 or over. You might be able to join if you have prostate cancer that has been confirmed by a doctor, if it has spread to other parts of your body, and if it's no longer responding to hormone treatment. You would also need to have received at least one type of hormone treatment that targets androgen receptors, and one or two courses of chemotherapy treatments called taxanes.

To be considered, you also need to be generally well enough to take part in a study. This is measured by something called an ECOG score, and you would need a score of 0 or 1, meaning you can carry out most or all of your daily activities.

However, you would not be able to join if your prostate cancer is a rare type (like small cell or neuroendocrine cancer). You also can't have any serious heart problems or other significant uncontrolled health issues like a bad infection. If you've already had a specific type of treatment called an "AR Degrader," you wouldn't be able to participate either.

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.

Are you an adult male aged 18 or over?
Do you have prostate cancer that has spread and is no longer responding to hormone therapy?
Have you already had at least one type of hormone treatment and 1-2 types of chemotherapy?
Do you generally feel well enough to carry out most daily activities?
Do you have any serious heart conditions or other major uncontrolled health problems?
Have you ever received a medicine called an 'AR Degrader'?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new study medicine, GSK5471713. You would have regular appointments at the hospital or clinic. These visits would involve various assessments, such as blood tests, urine tests, physical examinations, and possibly scans to check your general health and see how the medicine is affecting your body and your cancer. The research team will explain how often these visits will be and what exactly they will involve.

During the study, you will be closely monitored for any side effects or changes in your health. After you finish receiving the study treatment, there will be follow-up appointments to continue monitoring your health for a period. The total length of your participation, including treatment and follow-up, will be clearly explained by the study team.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as gaining access to a new treatment that isn't widely available yet, which might help your cancer when other treatments haven't. You will also receive careful medical monitoring. However, there are also potential risks; as this is a new medicine, there might be unknown side effects, and it's possible the treatment may not work for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

GSK Investigational Site
Verified postcode
Grand Rapids, United States· Recruiting
GSK Investigational Site
Verified postcode
Philadelphia, United States· Recruiting
GSK Investigational Site
Verified postcode
West Valley City, United States· Recruiting
GSK Investigational Site
Verified postcode
Toronto, Canada· Recruiting
GSK Investigational Site
Verified postcode
Montreal, Canada· Recruiting
GSK Investigational Site
Verified postcode
Tokyo, Japan· Recruiting

Common questions

What is mCRPC?

mCRPC stands for metastatic castration-resistant prostate cancer. This means prostate cancer that has spread to other parts of the body and is no longer responding to standard hormone therapy.

What does 'First-Time-in-Human Study' mean?

It means this is one of the very first times this new medicine is being given to people. The main aim is to check its safety and how the body reacts to it, before it's tested more widely.

Will I definitely get better if I join this study?

Not necessarily. This is a very early study and we don't know if the medicine will work. The main goal is to understand if it's safe and how it behaves in the body, while also looking for any hopeful signs against the cancer.

What kind of side effects might I experience?

Since this is a new medicine, all potential side effects are not yet fully known. The study team will monitor you very closely for any changes and explain what is currently known and what to look out for.

Can I leave the study if I change my mind?

Yes, absolutely. You have the right to stop participating in the study at any time, for any reason, without it affecting your future medical care.

How to find out more

US GSK Clinical Trials Call Center

gskclinicalsupporthd@gsk.com 877-379-3718 Official trial record

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