Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Phase I First Time in Human Open Label Study of GSK3745417 Administered With and Without Anticancer Agents in Participants With Advanced Solid Tumors

This is an early-stage medical study, often called a Phase 1 trial, looking into a new experimental medicine named GSK3745417. It's the very first time this drug will be given to people. The main goals are to find out if it's safe to use, what side effects it might cause, and what dose works best. Researchers will give GSK3745417 to people with advanced cancers, sometimes on its own, and sometimes combined with other commonly used cancer medicines to see how they work together. This study is open to both men and women, aged 18 and above, who have solid tumours that have spread or are difficult to treat. This kind of research is vital for developing new treatments for cancer patients in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Glaxosmithkline Research & Development Limited

Enrolment target

Start

26 Jun 2024

Neoplasms

What is this study about?

This study is a very early step in developing a new medicine. It's called a 'Phase 1' study, which means it's the first time this particular drug, named GSK3745417, will be given to people. The main purpose of studies like this isn't to cure cancer, but to learn important things about the new medicine.

The research team wants to find out if GSK3745417 is safe for people to take, what side effects it might have, and how much of it can be given before side effects become too strong. They will also look at how the body handles the medicine. In some cases, they will give GSK3745417 on its own, and in other cases, they will combine it with other medicines often used to treat cancer. This helps them understand if it works well with existing treatments.

This kind of research is crucial because it helps doctors decide if a new medicine is promising enough to be studied in larger groups of people. It's a key part of finding new ways to treat serious illnesses like cancer in the future. By taking part, you could be helping to advance medical science, even though the direct benefits to you might be limited.

Key takeaways

This is a 'first-in-human' study of a new cancer medicine.
The main goals are to check for safety and find the right dose.
It's for adults (18+) with advanced solid tumours, both men and women.
You might receive the new drug alone or with other cancer treatments.
Participation involves regular hospital visits and health monitoring.
You can stop participating at any time.

Who may be eligible?

To be able to join this study, you need to be at least 18 years old. The study is open to both men and women.

You would be considered if you have a type of cancer called a 'solid tumour' that is advanced. This usually means the cancer has spread in the body or hasn't responded well to standard treatments.

There will be other medical checks and tests to make sure that taking part in the study would be safe for you, and that your health condition allows you to correctly receive and be monitored for the study medication. The research team will carefully review your full medical history.

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.

Am I 18 years old or older?
Do I have an advanced solid tumour (a type of cancer that forms a lump)?
Am I open to having treatments alongside a new investigational drug?
Am I able to attend regular hospital appointments for tests and treatments?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital or clinic. These visits will include various tests such as blood tests, scans, and physical examinations. These tests are done to check your health, see how the study medicine is affecting your body, and monitor any side effects. You will be given the new study medicine, GSK3745417, as per the study schedule. Sometimes, this medicine might be given alongside other standard cancer treatments you are already receiving or that the doctors usually prescribe.

The study will involve several cycles of treatment. The number of cycles and how long you stay on the treatment will depend on how your body reacts to the medicine and if the doctors think it's still helping you. Even after you stop taking the study medicine, there will be follow-up appointments to monitor your health and recovery. The total duration of your participation could range from several months up to a year or more, depending on your individual response and the study's requirements.

Potential risks and benefits

As with any medical study, there are potential benefits and risks. You might not directly benefit from taking this new medicine, as the main goal is to understand its safety rather than to treat your cancer effectively at this early stage. However, you would be closely monitored by a dedicated medical team, and you could be among the first to receive a potentially important new treatment. The risks involve possible side effects from the new medicine, some of which might be unknown, as well as side effects from any existing treatments used alongside it. There may also be discomfort from tests and procedures. It's very important to remember that participating in a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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
France

Common questions

What does 'Phase 1' mean?

Phase 1 means this is the very first time this new medicine is being given to people. The main focus is on safety and finding the right dose, not on treating the illness yet.

Will this study cure my cancer?

At this early stage, the study's main goal is to understand if the medicine is safe and how it works, rather than to cure cancer. Direct benefits to you might be limited, but you're helping advance medical research.

What kind of cancers are included?

This study is for people with advanced 'solid tumours', which means cancers that form a lump or mass, rather than blood cancers.

Will I have to pay to be in the study?

No, you will not have to pay for the study medicine or study-related tests and procedures. These costs are covered by the study.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, without it affecting your future medical care. Your participation is completely voluntary.