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First-in-human Study of IDRX-42 for Advanced GIST

This study is testing a new drug called IDRX-42 for people with advanced gastrointestinal stromal tumors (GIST) that have spread (metastatic) or cannot be removed by surgery (unresectable). This is the first time IDRX-42 is being given to people. The study aims to see how safe IDRX-42 is, what side effects it might cause, and how well it works against GIST. You might be able to join if you are 18 or older, have GIST that has gotten worse after treatment with imatinib, and your tumor has specific genetic changes (mutations) in KIT or PDGFRA. Researchers will be looking at safety and side effects, and trying to find the best dose of IDRX-42. The study is currently recruiting up to 276 participants.

Study design
This is a Phase 1/1b, open-label study, meaning both you and your doctors will know you are receiving IDRX-42. It is the first time this drug is being tested in humans.
What's involved
You would receive IDRX-42 once or twice daily in continuous cycles of 28 days each. The study will assess safety and tolerability after one cycle (28 days) and over approximately 18 months.
Compensation
Not stated in the trial record.
Follow-up
Safety and tolerability will be assessed for approximately 18 months from the first participant enrolled.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05489237

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

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
IDRX, Inc., a wholly owned subsidiary of GSK, LLC
~276 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:IDRX-42

At a glance

Recruiting sites
0 of 31 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1 (Dose Escalation) - Safety and Tolerability (Nature, incidence, and severity of any DLTs)
Measured over When participant completes 1 cycle (28 days) treatment with safety and tolerability assessment by investigators
+6 more outcomes measured

Conditions

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

Explore related trials

Gastrointestinal Stromal TumorKIT GenePDGFRA Gene

Where it's being run

31 sites across 18 states
France4
South Korea4
China3
Japan3
Germany2
Netherlands2
United Kingdom2
Florida1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

What this trial measures

  • Phase 1 (Dose Escalation) - Safety and Tolerability (Nature, incidence, and severity of any DLTs)When participant completes 1 cycle (28 days) treatment with safety and tolerability assessment by investigators
  • Phase 1 (Dose Escalation) - Safety and Tolerability (Nature, incidence, and severity of any DLTs)Approximately 18 months from first participant enrolled
  • Phase 1 (Dose Escalation) - Determination of the MTD and/or RP1bD(s) of orally administered IDRX-42Approximately 18 months from first participant enrolled
  • Phase 1 (Dose Escalation) - C-QTc sub-study: QTcF - concentration response analysisAt the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)
  • Phase 1b-Number of participants with TEAEs and with laboratory test resultsApproximately 18 months
  • Phase 1b - Objective Response Rate (ORR) mRESIST v1.1Approximately 18 months
  • Phase 1b - C-QTcF sub-study: QTcF - concentration response analysisAt the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)