Active not recruitingPHASE1INTERVENTIONAL

First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors

This study is a first-time test in humans for a new treatment called remzistotug, along with other potential medicines like Dostarlimab. It's for people with advanced cancers that have come back in the local area or spread to other parts of the body, and for whom standard treatments haven't worked or are no longer an option. Researchers want to see if the new treatment is safe, how well people tolerate it, and how it moves through the body. The goal is to gather important information that could help develop better ways to treat these types of cancers in the future. The study involves different kinds of cancers, including head and neck, lung, and breast cancer, among others.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

GlaxoSmithKline

Enrolment target

152

Start

22 Mar 2022

Estimated completion

31 Aug 2027

Neoplasms

What is this study about?

This study is a really important step in developing new cancer treatments. It's called a 'first-in-human' study, which means it's the very first time this particular new medicine, named remzistotug, is being given to people. The main purpose is to carefully check if it's safe and to see how the body handles it. This is crucial information needed before a new medicine can be used more widely.

The study is for people who have advanced cancer that has either come back in the local area or spread to other parts of the body. These are situations where the usual treatments have already been tried and are no longer working, or if there are no other standard treatment options available. The types of cancers involved include common ones like head and neck, lung, breast, and bowel cancer, as well as several others.

By taking part, you would be helping doctors and scientists learn more about this potential new treatment. This knowledge could eventually lead to new and better ways to treat these difficult cancers for many people in the future. It's all about gathering information to make sure new medicines are both safe and effective.

Key takeaways

This is a 'first-in-human' study for a new cancer treatment called remzistotug.
It's for people with advanced cancers where standard treatments are no longer effective.
The main goals are to check the new treatment's safety and how the body handles it.
Participants will have regular check-ups, blood tests, and possibly tumour biopsies.
There's a chance to access a new treatment, but also unknown risks.
You can stop participating at any time without affecting your usual care.

Who may be eligible?

To join this study, you would need to be an adult, at least 18 years old. You must have a diagnosis of cancer that has come back in the local area or spread, and the standard treatments haven't worked or aren't suitable for you anymore. Your doctors would need to confirm that you are generally well enough to take part, meaning your body is functioning adequately and you have a life expectancy of at least 12 weeks. Your cancer also needs to be measurable, which means doctors can track its size.

For women, you cannot be pregnant or breastfeeding. If you are able to become pregnant, you would need to use highly effective contraception throughout the study and for a period afterwards. Men in certain parts of the study would also need to use contraception. There are also specific tests and health checks you'd need to pass to make sure the study treatment is as safe as possible for you. For some participants, a fresh biopsy of the tumour would be needed before starting treatment and again about six weeks later.

There are also reasons why you might not be able to join. For example, if you've already had certain types of cancer treatments or if your general health isn't considered strong enough for the study, you might not be eligible. The study team will review all your medical information carefully to see if you meet all the requirements.

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 cancer that has come back or spread, and are other treatments no longer working?
Are you generally well and capable of managing daily activities?
If you are a woman who can become pregnant, are you willing to use highly effective birth control?
Are you prepared to potentially have one or two fresh tumour biopsies?
Do you have a life expectancy of at least 12 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve several visits to the clinic for assessments. You would receive the study medication, which might be a new drug called remzistotug, potentially alongside other medicines. These visits would include check-ups, blood tests, and scans to monitor your health and how the treatment is affecting you and your cancer. For some, there would also be a need for a fresh tumour biopsy at the start and after about six weeks of treatment.

The research staff would explain the exact schedule of visits and tests, which may vary depending on how you respond to the treatment. There would also be follow-up appointments after you finish the treatment to continue monitoring your health. The total duration of your participation would depend on your individual response and the study's design.

Potential risks and benefits

Taking part in a clinical trial like this offers the potential benefit of accessing a new treatment that isn't widely available, especially if other standard options haven't worked for your cancer. However, as this is a new medicine, there are also potential risks, including side effects that are not yet fully known or understood. The study team will closely monitor you for any side effects and will provide care if they occur. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (26)

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

GSK Investigational Site
Verified postcode
San Francisco, United States
GSK Investigational Site
Verified postcode
Charlotte, United States
GSK Investigational Site
Verified postcode
Oklahoma City, United States
GSK Investigational Site
Verified postcode
Philadelphia, United States
GSK Investigational Site
Verified postcode
Dallas, United States
GSK Investigational Site
Verified postcode
San Antonio, United States
GSK Investigational Site
Verified postcode
Salt Lake City, United States
GSK Investigational Site
Verified postcode
Nedlands, Australia
GSK Investigational Site
Verified postcode
Ottawa, Canada
GSK Investigational Site
Verified postcode
Toronto, Canada
GSK Investigational Site
Verified postcode
Chengdu, China
GSK Investigational Site
Verified postcode
Jinan, China

Common questions

What is 'first-in-human' study?

It means this is the very first time this new treatment, remzistotug, will be tested in people to see if it's safe and how it works.

What kind of cancers are included?

This study includes several types of advanced cancers, such as head and neck, lung, breast, bowel, and kidney cancer, among others.

Why is this treatment being studied?

It's being studied for people whose cancer has returned or spread, and where standard treatments haven't worked well or are no longer an option.

Will I need to have a biopsy?

Yes, if you're in certain parts of the study, you'll need a fresh tumour biopsy before treatment and again about six weeks after starting.

What happens if I want to stop participating?

You can leave the study at any time, for any reason. Your decision will not affect your future medical care.