First-in-human Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors
← catalyst calendarNCT05489237 · readout in 202 d
Sponsored by IDRX, Inc., a wholly owned subsidiary of GSK, LLC (industry) · GSK — their whole pipeline →.
Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
276actual
Sites
31
Countries
Belgium, China, France +8
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-08-03 | actual | When the study began enrolling |
| Primary completion | 2027-03-10 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-03-26 | estimated | The whole study's end, after follow-up |
| First posted | 2022-08-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-02 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Gastrointestinal Neoplasms
- Gastrointestinal Stromal Tumor (GIST)
- Digestive System Disease
- Gastrointestinal Diseases
- Metastatic Cancer
Intervention
- Drug: IDRX-42
Primary outcomes
what the primary-completion date above is the date OFPhase 1 (Dose Escalation) - Safety and Tolerability (Nature, incidence, and severity of any DLTs)
measured 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)
measured Approximately 18 months from first participant enrolled
Phase 1 (Dose Escalation) - Determination of the MTD and/or RP1bD(s) of orally administered IDRX-42
measured Approximately 18 months from first participant enrolled
Phase 1 (Dose Escalation) - C-QTc sub-study: QTcF - concentration response analysis
measured At 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 results
measured Approximately 18 months
Phase 1b - Objective Response Rate (ORR) mRESIST v1.1
measured Approximately 18 months
Phase 1b - C-QTcF sub-study: QTcF - concentration response analysis
measured At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)
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