Active not recruitingPHASE1INTERVENTIONAL

Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors

This research is a first-of-its-kind study for new medicines (like GSK6097608 and belrestotug) designed to treat advanced solid tumors, which are cancers that have spread. The main goals are to check if these new drugs are safe, how much of them the body can handle, and if they start to show any signs of shrinking tumors. Researchers will test GSK6097608 by itself and with another approved drug called dostarlimab. They will also look at combinations of dostarlimab with other new drugs like belrestotug and cobolimab, especially in patients from Japan and China. The study aims to understand how these medicines work in the body at different doses.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

GlaxoSmithKline

Enrolment target

107

Start

25 Jun 2020

Estimated completion

31 Dec 2026

Neoplasms

What is this study about?

This clinical trial is designed to investigate new treatments for people with advanced solid tumors, which are cancers that have grown or spread in the body. If you have been told your cancer has progressed after standard treatments, or if those treatments aren't suitable for you, this study might be an option. It's an early-stage study, meaning these new drugs haven't been widely tested in humans before. This is a crucial step to make sure they are safe and to understand them better. Keep in mind that 'advanced solid tumors' refers to various types of cancer that affect solid organs, not blood cancers like leukaemia.

The main experimental drug in this study is called GSK6097608. Researchers want to see if it's safe to use, how the body processes it, and if it shows any early signs of benefit when given alone. They also want to test it in combination with other drugs, such as dostarlimab, which is already used to treat certain cancers, and other new drugs like belrestotug and cobolimab. By combining these treatments, doctors hope to find more effective ways to fight cancer.

The study involves different groups of patients, and some groups, particularly those from Japan and China, will help researchers understand how these drugs work in different populations. The ultimate goal is to find new and better ways to treat advanced cancers that currently have limited options, improving the lives of patients in the future.

Key takeaways

This study tests new cancer drugs (like GSK6097608) for advanced solid tumors.
It's a Phase 1 study, focusing on safety and finding the right dose.
Drugs are given alone or in combination with other treatments.
Eligibility depends on your cancer type, general health, and other factors.
You'll have regular hospital visits, blood tests, and scans.
Your safety will be closely monitored throughout the study.

Who may be eligible?

To join this study, you must be at least 18 years old, although in some parts of the study, particularly in Japan, you need to be 20 or older. You should have a type of solid cancer that has either advanced, come back, or spread to other parts of your body, and your current standard treatments are no longer working or aren't suitable for you.

You also need to be well enough to take part, meaning you can generally look after yourself and have healthy enough organs (like your heart, liver, and kidneys) as shown by blood tests and a heart scan. If you are female and could become pregnant, you must agree to use effective birth control during the study. Some parts of the study will specifically recruit people of Japanese or Chinese descent living in those countries.

There are also some reasons why you might not be able to join. For example, if you've had certain prior treatments or have other specific medical conditions that might interfere with the study drugs. The study team will carefully review your medical history to ensure your safety and that the study is appropriate 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 18 or older (or 20+ in certain Japanese groups)?
Do you have an advanced solid cancer that has progressed or for which standard treatments aren't suitable?
Are you generally well enough to do your daily activities?
Are your heart, liver, and kidneys working well enough?
If female, are you able to use effective contraception if you could become pregnant?
Are you willing and able to attend regular clinic visits and have tests done?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be assigned to a specific treatment group. This might involve receiving the new drug GSK6097608 by itself, or in combination with other drugs like dostarlimab, belrestotug, or cobolimab. The drugs will likely be given over a period of time, and you'll have regular visits to the clinic.

During these visits, the study team will perform various assessments. These include blood tests to check how the drug is affecting your body and how your organs are functioning. You'll also have scans (like CT or MRI) to see how your cancer is responding to the treatment. For some parts of the study, you might be asked to provide small tissue samples (biopsies) from your tumor before starting treatment and sometimes during treatment. You will be closely monitored for any side effects and your overall health. The total duration of the study participation will depend on your individual response and which group you are in, but the study team will explain everything in detail.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as receiving new treatments that aren't yet widely available. While these are early-stage drugs, there's a chance they could help shrink your tumor or slow its growth. However, there's no guarantee of benefit, and the main purpose is to learn more about these new drugs. As with any medication, there are potential risks and side effects that could occur. These will be fully explained to you by the study team, and you'll be carefully monitored for any problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (11)

GSK Investigational Site
Verified postcode
Los Angeles, United States
GSK Investigational Site
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Boston, United States
GSK Investigational Site
Verified postcode
Dallas, United States
GSK Investigational Site
Verified postcode
Houston, United States
GSK Investigational Site
Verified postcode
San Antonio, United States
GSK Investigational Site
Verified postcode
Ottawa, Canada
GSK Investigational Site
Verified postcode
Toronto, Canada
GSK Investigational Site
Verified postcode
Chiba, Japan
GSK Investigational Site
Verified postcode
Tokyo, Japan
GSK Investigational Site
Verified postcode
Seoul, South Korea
GSK Investigational Site
Verified postcode
Seoul, South Korea

Common questions

What is an advanced solid tumor?

It's a type of cancer that started in an organ or tissue (not blood) and has either grown larger, come back after treatment, or spread to other parts of the body.

What does a 'Phase 1' study mean?

Phase 1 is the first time a new medicine is tested in people. The main goal is to find out if it's safe and what the best dose is, rather than necessarily curing the disease.

Will I get the new drug, or a placebo (dummy drug)?

In this study, all participants will receive active treatment; there is no placebo. You will get either one of the new drugs alone, or in combination with other active drugs.

Do I need to have a biopsy if I join?

Some groups in the study will need to provide fresh tumor biopsies to help researchers understand the drugs better. The study team will tell you if this applies to your group.

What if I get side effects?

The study team will closely monitor you for any side effects. They will provide care and inform you about what to do if you experience any. Your safety is their top priority.