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New pill shows promise for tough stomach cancer in early trial

NCT ID NCT05489237

Disease control Sponsor: IDRX, Inc., a wholly owned subsidiary of GSK, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This first-in-human study tests an experimental oral drug called IDRX-42 in 278 adults with advanced gastrointestinal stromal tumors (GIST) that have spread or cannot be removed by surgery. The main goals are to check safety, find the right dose, and see if the drug can shrink tumors. All participants have already tried the standard drug imatinib without success.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IDRX-42 (an oral drug taken once or twice daily)
What this could lead to
If successful, this could provide a new treatment option for people with advanced GIST whose cancer has stopped responding to standard therapy.
What could go wrong
This is a very early (Phase 1) trial, so the drug may not work or could have unexpected side effects. It is only for people who have already tried imatinib.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

276 people

The number who actually took part.

Started

Aug 2022

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Phase 1 1. Male or female participants ≥18 years of age 2. Histologically or cytologically confirmed metastatic and/or surgically unresectable GIST 3. Documented progression on imatinib (Phase 1) 4. Documented pathogenic mutation in KIT OR any PDGFRA mutation other than exon 18 mutations, determined through local testing 5. At least one measurable lesion by mRECIST v1.1 for participants with GIST 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 7. Resolution of any toxicities from prior treatment(s) to ≤ Grade 1 by NCI CTCAE v5.0 criteria, or have resolved to baseline, at the time of first dose of study drug. 8. Willing and able to comply with scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions. Additional for Phase 1b Exploratory Cohorts 1. For Cohort 1, progressed on imatinib only (second line therapy) and refused or are ineligible for other standard of care (SOC) therapies. 2. For Cohort 2, progressed on both imatinib and sunitinib (third line therapy) or progressed on imatinib, sunitinib, and an additional agent (i.e., regorafenib or ripretinib) (fourth line therapy) or progressed on imatinib, sunitinib, regorafenib, and ripretininb (fifth line or greater therapy) 3. For Cohort 3 \[US, UK, China, and Japan only\], treatment naïve (first line therapy) and refused or are ineligible for other standard of care (SOC) therapies. 4. For Cohort 4, met the same criteria as Cohort 2 (third line or greater) and have also had prior treatment with investigational agents NB003 or THE-630 or a line of therapy of bezuclastinib plus sunitinib combination. Exclusion Criteria: 1. Any prior exposure to the following investigational agents NB003 or THE-630 or bezuclastinib plus sunitinib combination (except for participants treated in Cohort 4 of Phase 1b). 2. GIST with no documented mutation in both KIT and PDGFRA genes. 3. Primary brain malignancy or known untreated or active central nervous system metastases. 4. Has an active uncontrolled infection, including, but not limited to, the requirement for intravenous antibiotics. 5. Has significant, uncontrolled, or active cardiovascular disease.

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Conditions

The condition(s) this trial relates to.

Digestive System Diseases digestive system disorder digestive system neoplasm gastrointestinal stromal tumor metastatic malignant neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Digestive system disease Gastrointestinal diseases Gastrointestinal neoplasms Gastrointestinal stromal tumor (GIST) Metastatic cancer

Contacts and locations

Locations

  • GSK Investigational Site

    Miami, Florida, 33136, United States

  • GSK Investigational Site

    Chicago, Illinois, 60611, United States

  • GSK Investigational Site

    Boston, Massachusetts, 02215, United States

  • GSK Investigational Site

    St Louis, Missouri, 63129, United States

  • GSK Investigational Site

    New York, New York, 10065, United States

  • GSK Investigational Site

    Portland, Oregon, 97239, United States

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19111, United States

  • GSK Investigational Site

    Houston, Texas, 77030, United States

  • GSK Investigational Site

    Leuven, 3000, Belgium

  • GSK Investigational Site

    Beijing, 100142, China

  • GSK Investigational Site

    Guangzhou, China

  • GSK Investigational Site

    Wuhan, 430022, China

  • GSK Investigational Site

    Bordeaux, 33076, France

  • GSK Investigational Site

    Lyon, France

  • GSK Investigational Site

    Marseille, 13005, France

  • GSK Investigational Site

    Villejuif, 94805, France

  • GSK Investigational Site

    Berlin, Germany

  • GSK Investigational Site

    Essen, 45122, Germany

  • GSK Investigational Site

    Milan, 20133, Italy

  • GSK Investigational Site

    Chiba, 277-8577, Japan

  • GSK Investigational Site

    Kanagawa, 247-8533, Japan

  • GSK Investigational Site

    Tokyo, 104-0045, Japan

  • GSK Investigational Site

    Amsterdam, 1066 CX, Netherlands

  • GSK Investigational Site

    Rotterdam, 3075 EA, Netherlands

  • GSK Investigational Site

    Seongnam-si Gyeonggi-do, 463-707, South Korea

  • GSK Investigational Site

    Seoul, 120-752, South Korea

  • GSK Investigational Site

    Seoul, 5505, South Korea

  • GSK Investigational Site

    Seoul, 6351, South Korea

  • GSK Investigational Site

    Barcelona, Spain

  • GSK Investigational Site

    Leeds, LS9 7TF, United Kingdom

  • GSK Investigational Site

    London, SW3 6JJ, United Kingdom

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