RecruitingPHASE3INTERVENTIONAL

A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy

This clinical trial is looking at a new medicine, called IDRX-42, to treat a type of cancer known as Gastrointestinal Stromal Tumours, or GIST for short. GIST affects the digestive system. This study is for adults whose GIST has either spread to other parts of the body or cannot be completely removed by surgery. Critically, everyone joining this study will have already been treated with another medicine called imatinib, and it either didn't work well enough or caused too many side effects. In this study, IDRX-42 will be compared to an existing treatment called sunitinib. Researchers want to find out if IDRX-42 is both effective and safe for patients, hoping it might offer a better treatment option for those living with GIST.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

GlaxoSmithKline

Enrolment target

450

Start

03 Dec 2025

Estimated completion

29 Nov 2030

Gastrointestinal Neoplasms

What is this study about?

This study is comparing a new medication, IDRX-42, with an existing treatment called sunitinib, for people who have a type of cancer known as Gastrointestinal Stromal Tumours (GIST). GIST is a cancer that usually starts in the digestive system. The main goal of this research is to see if IDRX-42 is a good treatment option for patients, especially if their cancer has spread or can't be treated with surgery, and if they've already tried another drug called imatinib.

Researchers want to understand how well IDRX-42 works at shrinking or controlling the cancer, and also if it's safe to take. This kind of study helps doctors find new and better ways to treat cancer, giving patients more options in the future. By comparing it to an existing treatment, they can see if the new drug offers any advantages.

Taking part in a study like this is an important way for patients to get access to promising new treatments. It also helps the medical community learn more about GIST and develop effective therapies for everyone affected by it.

Key takeaways

The study compares a new drug (IDRX-42) to an existing one (sunitinib) for GIST.
It's for adults whose GIST has spread or can't be removed by surgery.
Participants must have already tried the drug imatinib.
The main goals are to check if IDRX-42 works well and is safe.
Taking part helps doctors find better treatments for GIST.
You can stop participating at any time.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 or older.

Specifically, you must have a confirmed diagnosis of Gastrointestinal Stromal Tumours (GIST) that has either spread to other parts of your body or cannot be completely removed by surgery. It's also important that your GIST has continued to grow or caused problems even after you've been treated with the drug imatinib. The doctors will also need to review some tissue from your cancer, either from an old biopsy or by taking a new small sample.

There are also some reasons why you might not be able to join. For example, if you have cancer that has spread to your brain and isn't being treated, or if you've had a bad allergic reaction to similar drugs in the past. Also, if you have another type of cancer that has recently spread or needed active treatment, you might not be able to participate, unless it's a very common skin cancer or a very early-stage cancer that has been successfully removed.

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 GIST that has spread or can't be surgically removed?
Has your GIST progressed or caused problems after taking imatinib?
Do you have a tissue sample (old or new) of your GIST available?
Do you know if you have untreated cancer in your brain?
Do you have any severe allergies to similar cancer medications?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the clinic for check-ups and to receive your study medication, which would be either IDRX-42 or sunitinib. You wouldn’t get to choose which one you receive. During these visits, the medical team will monitor your health, check how you're responding to the treatment, and look out for any side effects. This will involve regular blood tests, scans (like CT scans) to see how your GIST is responding, and assessments of your general well-being.

The study would last for a period of time decided by the doctors, which will include the treatment phase and a follow-up period to continue monitoring your health and the effects of the medication. The research team will explain all the details, including the schedule of visits and procedures, before you decide to join.

Potential risks and benefits

Participating in this study might mean you could benefit from a new treatment, IDRX-42, which could be more effective than existing options for your GIST. However, as with any medication, there are potential risks and side effects. Both IDRX-42 and sunitinib can have side effects, which the medical team will explain fully and monitor closely. You will be provided with detailed information about all possible risks. It is important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (121)

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

GSK Investigational Site
Verified postcode
Phoenix, United States· Recruiting
GSK Investigational Site
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La Jolla, United States· Recruiting
GSK Investigational Site
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Los Angeles, United States· Recruiting
GSK Investigational Site
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San Francisco, United States· Recruiting
GSK Investigational Site
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New Haven, United States· Recruiting
GSK Investigational Site
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Jacksonville, United States· Recruiting
GSK Investigational Site
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Miami, United States· Recruiting
GSK Investigational Site
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Orlando, United States· Recruiting
GSK Investigational Site
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Tampa, United States· Recruiting
GSK Investigational Site
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Iowa City, United States· Recruiting
GSK Investigational Site
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Overland Park, United States· Recruiting
GSK Investigational Site
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Boston, United States· Recruiting

Common questions

What is GIST?

GIST stands for Gastrointestinal Stromal Tumours. It's a rare type of cancer that typically starts in the digestive system, most commonly in the stomach or small intestine.

What is imatinib?

Imatinib is a medicine often used as a first treatment for GIST. It works by blocking certain signals in cancer cells that help them grow.

What is sunitinib?

Sunitinib is another medicine used to treat GIST, especially if imatinib hasn't worked well enough or has caused too many side effects. It also targets pathways that help cancer cells grow.

Will I know if I'm getting the new drug or the old one?

In this type of study, participants are usually randomly assigned to receive either the new drug (IDRX-42) or the existing one (sunitinib). This is done by chance, like flipping a coin, so neither you nor your doctor will usually know which one you are receiving during your treatment, unless there's a medical reason to find out.

What are biomarkers?

Biomarkers are characteristics that can be measured to give an indication about your health or disease. In this study, they will look at cancer tissue to learn more about your GIST and how it might respond to treatments.

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.