{"preliminary_commentary":{"by_channel":{"x_thread":28,"podcast":22,"youtube":14},"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\": \"NCT03093116\", \"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":"TRIDENT-1","nct_id":"NCT03093116","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=trident-1-nct03093116. 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":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"TRIDENT-1","arms":[{"description":"Phase 1\n\nOral repotrectinib (TPX-0005):\n\nPhase 1a dose escalation, Phase 1b food-effect sub-study, and Phase 1c dose escalation with food, and Midazolam drug-drug interaction sub-study.\n\nPhase 2\n\nOral repotrectinib (TPX-0005): 6 distinct expansion cohorts\n\n* EXP-1: ROS1 TKI-naïve ROS1+ NSCLC\n* EXP-2: 1 Prior ROS1 TKI and 1 Platinum based chemo ROS1+ NSCLC\n* EXP-3: 2 Prior ROS1 TKIs ROS1+ NSCLC (No Chemo or IO)\n* EXP-4: 1 Prior ROS1 TKI ROS1+ NSCLC (No Chemo or IO)\n* EXP-5: TRK TKI-naïve NTRK+ solid tumors\n* EXP-6: TRK TKI-pretreated NTRK+ solid tumors","label":"Repotrectinib (TPX-0005)","type":"EXPERIMENTAL"}],"collaborators":["Zai Lab (Shanghai) Co., Ltd."],"completion_date":{"date":"2028-02-29","type":"ESTIMATED"},"conditions":["Locally Advanced Solid Tumors","Metastatic Solid Tumors"],"enrollment":{"count":500,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Oral repotrectinib (TPX-0005)","otherNames":["repotrectinib"],"type":"DRUG"}],"last_update":"2026-05-27","lead_sponsor":"Turning Point Therapeutics, Inc.","official_title":"A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)","overall_status":"RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2028-02-29","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Dose limiting toxicities (DLTs) (Phase 1)","timeFrame":"Within 28 days of the first repotrectinib dose"},{"measure":"Recommended Phase 2 Dose (RP2D) (Phase 1)","timeFrame":"Within 28 days of the last patient dosed in escalation"},{"measure":"Overall Response Rate (ORR) Phase 2","timeFrame":"Two to three years after first dose of repotrectinib dose"}],"references":[{"citation":"Besse B, Lin JJ, Bazhenova L, Goto K, de Langen AJ, Kim DW, Wolf J, Springfeld C, Popat S, Lim DWT, Nagasaka M, Hong JY, Baik CS, Hervieu A, Moreno V, Yang N, Kollengode K, Yang H, Xu Y, Calvet CY, Yuan Y, Hammell AB, Drilon A, Solomon BJ. Repotrectinib in NTRK fusion-positive advanced solid tumors: a phase 1/2 trial. Nat Med. 2026 Feb;32(2):682-689. doi: 10.1038/s41591-025-04079-7. Epub 2026 Feb 4.","pmid":"41639379","type":"DERIVED"},{"citation":"Ajani JA, D'Amico TA, Bentrem DJ, Corvera CU, Das P, Enzinger PC, Enzler T, Gerdes H, Gibson MK, Grierson P, Gupta G, Hofstetter WL, Ilson DH, Jalal S, Kim S, Kleinberg LR, Klempner S, Lacy J, Lee B, Licciardi F, Lloyd S, Ly QP, Matsukuma K, McNamara M, Merkow RP, Miller AM, Mukherjee S, Mulcahy MF, Perry KA, Pimiento JM, Reddi DM, Reznik S, Roses RE, Strong VE, Su S, Uboha N, Wainberg ZA, Willett CG, Woo Y, Yoon HH, McMillian NR, Stein M. Gastric Cancer, Version 2.2025, NCCN Clinical Practice Guidelines In Oncology. J Natl Compr Canc Netw. 2025 May;23(5):169-191. doi: 10.6004/jnccn.2025.0022.","pmid":"40341199","type":"DERIVED"},{"citation":"Drilon A, Camidge DR, Lin JJ, Kim SW, Solomon BJ, Dziadziuszko R, Besse B, Goto K, de Langen AJ, Wolf J, Lee KH, Popat S, Springfeld C, Nagasaka M, Felip E, Yang N, Velcheti V, Lu S, Kao S, Dooms C, Krebs MG, Yao W, Beg MS, Hu X, Moro-Sibilot D, Cheema P, Stopatschinskaja S, Mehta M, Trone D, Graber A, Sims G, Yuan Y, Cho BC; TRIDENT-1 Investigators. Repotrectinib in ROS1 Fusion-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2024 Jan 11;390(2):118-131. doi: 10.1056/NEJMoa2302299.","pmid":"38197815","type":"DERIVED"},{"citation":"Yun MR, Kim DH, Kim SY, Joo HS, Lee YW, Choi HM, Park CW, Heo SG, Kang HN, Lee SS, Schoenfeld AJ, Drilon A, Kang SG, Shim HS, Hong MH, Cui JJ, Kim HR, Cho BC. Repotrectinib Exhibits Potent Antitumor Activity in Treatment-Naive and Solvent-Front-Mutant ROS1-Rearranged Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 Jul 1;26(13):3287-3295. doi: 10.1158/1078-0432.CCR-19-2777. Epub 2020 Apr 8.","pmid":"32269053","type":"DERIVED"},{"citation":"Drilon A, Ou SI, Cho BC, Kim DW, Lee J, Lin JJ, Zhu VW, Ahn MJ, Camidge DR, Nguyen J, Zhai D, Deng W, Huang Z, Rogers E, Liu J, Whitten J, Lim JK, Stopatschinskaja S, Hyman DM, Doebele RC, Cui JJ, Shaw AT. Repotrectinib (TPX-0005) Is a Next-Generation ROS1/TRK/ALK Inhibitor That Potently Inhibits ROS1/TRK/ALK Solvent- Front Mutations. Cancer Discov. 2018 Oct;8(10):1227-1236. doi: 10.1158/2159-8290.CD-18-0484. Epub 2018 Aug 9.","pmid":"30093503","type":"DERIVED"}],"start_date":{"date":"2017-03-07","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements","url":"https://clinicaltrials.gov/study/NCT03093116"},"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/trident-1-nct03093116"}