{"commentary":{"count":21,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":21},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04526106\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"NCT04526106","nct_id":"NCT04526106","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04526106. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1250,"size":"standard","size_rule":"Standard: 13–40 commentary sources"},"registry":{"acronym":null,"arms":[{"description":"Multiple doses of RLY-4008 for oral administration.","label":"Part 1: Dose Escalation","type":"EXPERIMENTAL"},{"description":"Oral dose of RLY-4008 as determined during Part 1 Dose Escalation.","label":"Part 2: Dose Expansion","type":"EXPERIMENTAL"},{"description":"Oral dose of RLY-4008 as determined during Part 1 Dose Escalation.","label":"Part 3: Extension","type":"EXPERIMENTAL"},{"description":"Oral dose of RLY-4008 as determined during Part 1 Dose Escalation.","label":"Part 4: Rollover","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2025-09-05","type":"ACTUAL"},"conditions":["FGFR2 Amplification","FGFR2 Gene Mutation","FGFR2 Gene Fusion/Rearrangement","FGFR2 Gene Translocation","FGFR2 Gene Activation","Intrahepatic Cholangiocarcinoma","Cholangiocarcinoma","Other Solid Tumors, Adult"],"enrollment":{"count":490,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"RLY-4008","type":"DRUG"}],"last_update":"2026-02-27","lead_sponsor":"Elevar Therapeutics","official_title":"A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors","overall_status":"COMPLETED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2025-09-05","type":"ACTUAL"},"primary_outcomes":[{"measure":"Part 1 and Part 4: Number of patients with adverse events and serious adverse events","timeFrame":"Every cycle (4-week cycles) until study discontinuation, approximately 24 months"},{"measure":"Part 1: Determination of maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RLY-4008","timeFrame":"Cycle 1 (4-week cycle) of treatment for MTD and at the end of every cycle (4-week cycles) for RP2D until study discontinuation, approximately 24 months"},{"measure":"Part 2 and Part 3: Objective Response Rate (ORR) assessed by Independent Review Committee per RECIST v1.1","timeFrame":"Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months"},{"measure":"Part 4: Number of patients with dose interruptions","timeFrame":"Every 28-day cycle until end of treatment, approximately 24 months."},{"measure":"Part 4: Number of patients with dose reductions","timeFrame":"Every 28-day cycle until end of treatment, approximately 24 months."},{"measure":"Part 4: Number of patients with dose discontinuations","timeFrame":"Every 28-day cycle until end of treatment, approximately 24 months."}],"references":[{"citation":"Ellis H, Balasooriya ER, Varkaris A, Hajian B, Wan J, Shekhar M, Gritti I, Vijay V, Albertelli L, Piot S, Lau K, Kehlmann A, Chevalier N, Nugent FW, Zhen Y, Silveira VS, Sellers WR, Corcoran RB, Juric D, Bardeesy N. Mechanisms of clinical resistance to selective FGFR2 inhibition by lirafugratinib. Ann Oncol. 2026 Jun;37(6):798-812. doi: 10.1016/j.annonc.2026.01.004. Epub 2026 Jan 20.","pmid":"41571046","type":"DERIVED"}],"start_date":{"date":"2020-09-02","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors","url":"https://clinicaltrials.gov/study/NCT04526106"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct04526106"}