RecruitingPHASE1INTERVENTIONAL

First-in-human Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors

This study is the very first time a new drug called IDRX-42 is being tested in people. This drug is for adults who have a type of cancer called gastrointestinal stromal tumor (GIST) that has spread or can't be removed by surgery. The main goals are to check if IDRX-42 is safe, how well people tolerate it, and how their bodies process the drug. Researchers will also look for early signs that the drug might be helping to control the cancer. The study has two main parts: first, finding the right dose, and then, looking more closely at how effective and safe the drug is at that dose for different groups of patients with GIST.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

IDRX, Inc., a wholly owned subsidiary of GSK, LLC

Enrolment target

278

Start

03 Aug 2022

Estimated completion

28 Jun 2028

Gastrointestinal Neoplasms Gastrointestinal Stromal Tumor (GIST)Digestive System Disease Gastrointestinal Diseases Metastatic Cancer

What is this study about?

This clinical trial is designed to test a new medication called IDRX-42. It's considered a "first-in-human" study, which means it's the very first time this particular drug is being given to people. The study is for adults who have a specific type of cancer called gastrointestinal stromal tumor, often shortened to GIST. This is a rare cancer that starts in the digestive system. Specifically, this study is for people whose GIST has either spread to other parts of the body (metastatic) or cannot be completely removed by surgery (unresectable).

The main purpose of this research is to see if IDRX-42 is safe for people. Doctors will also be looking at how well people tolerate the drug and how their bodies handle it. Another important part of the study is to see if there are any early signs that IDRX-42 might be effective in shrinking or stopping the growth of GIST tumors. Ultimately, this research aims to understand if IDRX-42 could be a helpful new treatment option for people living with advanced GIST.

The study is split into two parts. In the first part, researchers will gradually increase the dose of IDRX-42 in small groups of patients to find the safest and most effective dose. Once that dose is found, the second part of the study will involve more people to get a clearer idea of how well the drug works and its safety. They will look at different groups of patients, including some who haven't had much previous treatment and others who have tried several other GIST medications.

Key takeaways

This is the first human study of a new GIST drug, IDRX-42.
It's for adults with advanced GIST that has spread or can't be removed by surgery.
The main goals are to check safety, how the body handles the drug, and early signs of it helping the cancer.
Participation involves taking the drug, regular check-ups, blood tests, and scans.
You have the right to leave the study at any time.

Who may be eligible?

To join this study, you generally need to be at least 18 years old and have a confirmed diagnosis of GIST that has spread or can't be surgically removed. Your GIST must also show a specific genetic change (mutation) in either the KIT or PDGFRA genes.

For the first part of the study, you must have tried and progressed on a medicine called imatinib. You also need to be well enough to take part, meaning you can carry out your daily activities with little or no difficulty, and any side effects from previous treatments must have mostly cleared up.

There are different groups in the study depending on your past treatments for GIST. For example, some groups are for people who have only used imatinib, while others are for those who have tried more treatments. Certain conditions might prevent you from joining, such as having a specific type of GIST mutation, or having tried particular experimental GIST drugs in the past (unless you're in a specific group designed for that).

Quick self-check

Are you 18 years or older?
Do you have advanced GIST that has spread or cannot be surgically removed?
Has your GIST been shown to have a specific genetic change (mutation) in KIT or PDGFRA?
Have you tried and progressed on imatinib (for the first part of the study)?
Are you generally well enough to participate in daily activities?
Are you able to attend regular appointments and follow study instructions?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will be given the study drug, IDRX-42, which is taken by mouth. You will have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the drug is affecting your cancer. These visits will help doctors understand how your body is handling the medication and if your tumors are responding. You'll also have heart tests (ECGs) to check for any effects on your heart rhythm. The total length of your participation will depend on how you respond to the treatment and what the study doctors advise, but generally, you'll continue treatment as long as it's benefiting you and you're not experiencing severe side effects. Regular follow-up appointments will continue even after you stop taking the study drug.

Potential risks and benefits

Like all clinical trials, there are potential benefits and risks to consider. A possible benefit is that IDRX-42 might help control your GIST if other treatments haven't worked or are no longer effective. However, since this is a new drug, not all its effects are known. There's a risk of experiencing side effects, some of which could be serious. The study team will carefully monitor you for any side effects and manage them as best they can. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (31)

GSK Investigational Site
Miami, United States· Recruiting
GSK Investigational Site
Chicago, United States· Recruiting
GSK Investigational Site
Boston, United States· Recruiting
GSK Investigational Site
St Louis, United States· Recruiting
GSK Investigational Site
New York, United States· Recruiting
GSK Investigational Site
Portland, United States· Recruiting
GSK Investigational Site
Philadelphia, United States· Recruiting
GSK Investigational Site
Houston, United States· Recruiting
GSK Investigational Site
Leuven, Belgium· Recruiting
GSK Investigational Site
Beijing, China· Recruiting
GSK Investigational Site
Guangzhou, China· Recruiting
GSK Investigational Site
Wuhan, China· Recruiting

+19 more sites — see the official record for the full list.

Common questions

What is GIST?

GIST stands for Gastrointestinal Stromal Tumor. It's a type of cancer that starts in the specialized cells of the digestive system.

What does 'first-in-human' mean?

It means this is the very first time this specific drug (IDRX-42) is being tested in people to see how it works and if it's safe.

What is IDRX-42?

IDRX-42 is a new experimental drug, taken by mouth, that aims to block certain signals within cancer cells that help them grow. It's called a tyrosine kinase inhibitor.

Will IDRX-42 cure my GIST?

This study aims to see if IDRX-42 can help control or shrink GIST tumors. As it's an early-stage trial, it's not known if it will lead to a cure.

What if I experience side effects?

The study team will closely monitor you. If you experience any side effects, they will provide care and guidance. You can always discuss your concerns with the study doctors.

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.