AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

First time in human (FTIH) study to investigate the safety and preliminary activity of GSK5533524 alone or in combination in adult participants with advanced solid tumors

This research is a 'first-in-human' study, which means it's the very first time this new medicine, called GSK5533524, is being given to people. The main goals are to carefully check if the new medicine is safe for adults who have advanced cancers (neoplasms). Researchers will also be looking to see if it shows any early signs of helping to treat these cancers. They will test the medicine by itself and also in combination with other treatments. This is a very early stage of research, like taking the first few steps on a long journey to find new ways to fight cancer.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Glaxosmithkline Research & Development Limited

Enrolment target

Start

21 May 2026

Neoplasms

What is this study about?

Imagine scientists have developed a brand new key they hope might unlock a way to fight cancer. Before they can use this key widely, they need to make sure it's safe and if it actually works. This study is exactly that first important step.

It's called a 'first-in-human' study, which simply means it's the first time this specific new medicine, named GSK5533524, is being given to people. The most important thing for the researchers is to carefully check for any side effects and understand how the body reacts to the medicine. They'll also be watching closely to see if there are any early hints that the medicine might be helping to slow down or shrink advanced cancers.

This new medicine will be tested both on its own and in combination with other treatments, to see if working together makes it more effective. It's important to remember this is very early research, and while it's an exciting step forward, it's about learning as much as possible about this new potential treatment.

Key takeaways

This is a very early-stage study (first-in-human) of a new medicine.
The main goals are to check the medicine's safety and look for early signs of effectiveness in people with advanced cancers.
The new medicine is called GSK5533524.
It will be tested alone and sometimes with other treatments.
It's for adults aged 18 and over, both men and women.
Joining is voluntary, and you can leave at any time.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults can also be considered.

This study is for people who have advanced cancer, which is sometimes called 'neoplasms'. It is open to both men and women.

Beyond these basic requirements, there would be other specific health checks and medical conditions that the study doctors would need to review to make sure it's safe and appropriate for you to join. If you're interested, your doctor can look at all the detailed criteria.

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 18 years old or older?
Do you have advanced solid cancer?
Are you able to travel to the study site for appointments?
Are you willing to follow all study rules and attend scheduled visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in a study like this, it typically involves several visits to the clinic or hospital. These visits would be for important assessments such as blood tests, scans, and physical examinations. You would receive the study medicine (GSK5533524) as directed by the study doctors. After finishing the study treatment, there would usually be follow-up visits or calls to keep monitoring your health. The total time you spend in the study, from your first visit to your last follow-up, can vary greatly but will be clearly explained to you before you agree to take part.

Potential risks and benefits

Participating in research studies like this can have potential benefits, such as receiving a new medicine that isn't widely available yet, which might help your condition. However, there are also potential risks, as this is a new medicine and not all side effects are known. You might experience side effects that range from mild to serious. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Denmark
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Unverified
Finland
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Unverified
France

Common questions

What does 'first-in-human' mean?

It means this is the very first time this new medicine is being given to people. It's a key first step in testing its safety and if it works.

What type of cancer is this study for?

This study is for adults who have advanced solid tumors, which doctors sometimes call 'neoplasms'.

What is GSK5533524?

GSK5533524 is the name of the new medicine being tested in this study. It's a new compound that scientists hope may help fight cancer.

Will I definitely get better if I join?

No, there's no guarantee. This is a very early study to learn if the medicine is safe and shows any signs of helping. It's not a guaranteed treatment.

Can I leave the study if I change my mind?

Yes, absolutely. You can withdraw from the study at any time, without giving a reason, and it won't affect your future medical care.