RecruitingPHASE1INTERVENTIONAL

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 study is the first time a new drug called GSK5533524 is being tested in people with advanced solid tumours. The main aim is to find out if the drug is safe and what the best dose is for future testing. Researchers will also be looking to see if the drug can shrink tumours, slow their growth, or if people tolerate it well. They will also learn how the body handles the drug and whether the immune system reacts to it. This study is for adults whose cancer has spread and for whom standard treatments haven't worked or aren't suitable. It's a very early stage of testing, focusing on safety and basic understanding of the drug's effects.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

GlaxoSmithKline

Enrolment target

Start

23 Mar 2026

Estimated completion

06 Feb 2029

Neoplasms

What is this study about?

This study is investigating a new medication called GSK5533524. Since this is the very first time it's being given to people, it's called a 'First Time in Human' study. The main goals are to carefully check how safe the drug is, find the right dose that people can comfortably take, and understand any side effects. Researchers will also observe how the drug behaves in the body – for example, how it's absorbed and broken down. They hope to get an early idea of whether the drug has any positive effects on cancer, such as shrinking tumours or slowing their growth. It's important to remember that this is an early-stage study, so the focus is primarily on safety and understanding the drug.

This research is for adults who have advanced solid tumours. 'Advanced' means the cancer may have spread, and 'solid tumours' refer to cancers that form a lump or mass, rather than blood cancers. Importantly, participants in this study would have already tried other standard treatments that are no longer working, or they can't have those treatments for other health reasons. This study aims to explore a new potential treatment option when other avenues have been exhausted.

By taking part, you would be helping doctors and scientists learn more about this potential new drug. This kind of early research is crucial for developing new medicines for cancer. Even if an individual participant doesn't directly benefit, the information gathered helps future patients. The study will also look for any signs that your body's immune system reacts to the treatment, which is important for understanding how the drug works.

Key takeaways

This is a very early study of a new cancer drug.
The main goals are to check the drug's safety and find the best dose.
It's for adults with advanced solid tumours who have limited treatment options.
You'll be closely monitored by a medical team.
There's a chance of side effects, as with any new medicine.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. You must have a solid tumour cancer that has been confirmed by a doctor, is advanced, and has either resisted standard treatments, or you can't have those treatments. Your cancer must also show signs of growing or getting worse with your current or recent treatment.

Doctors will check that your general health is good enough to take part, including your heart, kidneys, and other important organs. Your usual daily activities shouldn't be too limited by your health. You also need to have at least one spot where the tumour can be measured accurately by scans.

There are also some reasons why you might not be able to join. These include having certain heart problems, untreated or worsening brain cancer, or severe eye or lung conditions. History of serious autoimmune diseases, ongoing severe side effects from previous treatments, or allergies to the study drug would also prevent you from participating. Doctors will review your full medical history to make sure the study is safe for you.

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 at least 18 years old?
Do you have an advanced solid tumour that hasn't responded to standard treatments, or you can't have them?
Has your cancer recently shown signs of getting worse?
Is your general health good enough to take part, including your heart and kidneys?
Are you able to manage your daily activities without too much difficulty?

Answer every question to see your result.

What does participation involve?

If you join this study, you will take the new medication, GSK5533524. The study is divided into different parts, and if you are in the initial part, you will help researchers find the safest dose and monitor your body's reaction to the drug for the first time. You will have regular visits to the clinic for check-ups, which will include blood tests, scans, and other assessments to monitor your health, how the drug is working, and any side effects. These visits will be more frequent at the beginning of the study. The total length of your participation will vary, but you will be monitored closely throughout the treatment and for a period afterwards to make sure you are well and to track any longer-term effects of the drug. The exact number of visits, tests, and overall duration will be explained fully by the study team.

Potential risks and benefits

Taking part in a first-in-human study like this means there's a chance you might experience side effects from the new drug, some of which might be unknown. The study team will closely monitor you to manage any side effects. While the main goal is to understand safety and dosing, there is a possibility that the drug might help shrink your tumour or slow its growth, but this is not guaranteed as it's an early-stage study. You can choose to leave the study at any time, for any reason, without it affecting your future medical care.

Locations (16)

GSK Investigational Site
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Philadelphia, United States· Recruiting
GSK Investigational Site
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San Antonio, United States· Recruiting
GSK Investigational Site
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Toronto, Canada· Recruiting
GSK Investigational Site
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Montreal, Canada· Recruiting
GSK Investigational Site
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Montreal, Canada· Recruiting
GSK Investigational Site
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Helsinki, Finland· Recruiting
GSK Investigational Site
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Saitama, Japan· Recruiting
GSK Investigational Site
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Shizuoka, Japan· Recruiting
GSK Investigational Site
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Tokyo, Japan· Recruiting
GSK Investigational Site
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Tokyo, Japan· Recruiting
GSK Investigational Site
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Barcelona, Spain· Recruiting
GSK Investigational Site
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Madrid, Spain· Recruiting

Common questions

What kind of cancer is this study for?

This study is for adults with advanced solid tumours, which means cancers that form a mass and may have spread.

What does 'First Time in Human' mean?

It means this is the first time the new drug, GSK5533524, is being given to people. The main focus is on safety and finding the right dose.

Will this drug cure my cancer?

It's too early to know if this drug will cure cancer. The study is mainly focused on safety and understanding how the drug works at this very early stage.

What if I have side effects?

The study team will carefully monitor you for any side effects and provide care and support to manage them.

Can I leave the study if I change my mind?

Yes, you can decide to stop participating in the study at any time, for any reason, and it won't affect your regular 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.