{"preliminary_commentary":{"by_channel":{"bluesky_thread":6,"youtube":1,"podcast":1,"x_thread":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT05489237\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"name":"IDRX-42-001","nct_id":"NCT05489237","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=idrx-42-001-nct05489237. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants should have advanced (metastatic and/or surgically unresectable) GIST, following failure of at least prior imatinib therapy due to progression of GIST.","label":"Dose Escalation (Phase I)","type":"EXPERIMENTAL"},{"description":"Participants with advanced GIST who have had GIST progression after first-line imatinib only (second line therapy setting) and refused or are ineligible for other standard of care (SOC) therapies.","label":"(Phase 1b) Cohort 1 - Participants with GIST progression after first-line imatinib therapy","type":"EXPERIMENTAL"},{"description":"Participants with metastatic and/or surgically unresectable GIST following progression EITHER after sequential imatinib then sunitinib (third-line therapy setting) OR after imatinib, sunitinib, and then an additional TKI agent (i.e., regorafenib or ripretinib) (fourth-line therapy setting) OR after imatinib, sunitinib, regorafenib, and ripretinib (5th line or greater therapy).","label":"(Phase 1b): Cohort 2 - Participants with GIST progression after 2 or more lines of TKI therapy","type":"EXPERIMENTAL"},{"description":"Participants with metastatic and/or surgically unresectable GIST who are treatment naïve (first line therapy) and refused or are ineligible for other standard of care (SOC) therapies.","label":"(Phase 1b): Cohort 3 - Participants with GIST who are treatment naïve","type":"EXPERIMENTAL"},{"description":"Participants with GIST progression who meet the same criteria as Cohort 2 (third line or greater TKI therapy) and have had prior treatment with investigational agents NB003 or THE-630 or a line of therapy of bezuclastinib plus sunitinib combination.","label":"(Phase 1b): Cohort 4","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-03-26","type":"ESTIMATED"},"conditions":["Gastrointestinal Neoplasms","Gastrointestinal Stromal Tumor (GIST)","Digestive System Disease","Gastrointestinal Diseases","Metastatic Cancer"],"enrollment":{"count":276,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"IDRX-42","otherNames":[],"type":"DRUG"}],"last_update":"2026-10-05","lead_sponsor":"IDRX, Inc., a wholly owned subsidiary of GSK, LLC","official_title":"A FIRST-IN-HUMAN (FIH) STUDY OF IDRX-42 IN PARTICIPANTS WITH METASTATIC AND/OR UNRESECTABLE GASTROINTESTINAL STROMAL TUMORS (GIST)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2027-03-10","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Phase 1 (Dose Escalation) - Safety and Tolerability (Nature, incidence, and severity of any DLTs)","timeFrame":"When participant completes 1 cycle (28 days) treatment with safety and tolerability assessment by investigators"},{"measure":"Phase 1 (Dose Escalation) - Safety and Tolerability (Nature, incidence, and severity of any DLTs)","timeFrame":"Approximately 18 months from first participant enrolled"},{"measure":"Phase 1 (Dose Escalation) - Determination of the MTD and/or RP1bD(s) of orally administered IDRX-42","timeFrame":"Approximately 18 months from first participant enrolled"},{"measure":"Phase 1 (Dose Escalation) - C-QTc sub-study: QTcF - concentration response analysis","timeFrame":"At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)"},{"measure":"Phase 1b-Number of participants with TEAEs and with laboratory test results","timeFrame":"Approximately 18 months"},{"measure":"Phase 1b - Objective Response Rate (ORR) mRESIST v1.1","timeFrame":"Approximately 18 months"},{"measure":"Phase 1b - C-QTcF sub-study: QTcF - concentration response analysis","timeFrame":"At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days)"}],"references":[],"start_date":{"date":"2022-08-03","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"First-in-human Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors","url":"https://clinicaltrials.gov/study/NCT05489237"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/idrx-42-001-nct05489237"}