{"entity":{"id":"nct03093116","kind":"trial","name":"A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements","aka":["TRIDENT-1"],"tldr":"A phase 1/2 trial of Repotrectinib in advanced solid tumours, run by Turning Point Therapeutics, Inc., now recruiting.","summary":"A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements is a phase 1/2 interventional study registered as NCT03093116 by Turning Point Therapeutics, Inc., with 500 participants planned, started 2017-03-07 and due to reach its primary completion in 2028-02-29. Interventions recorded: Oral repotrectinib (TPX-0005).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03093116","url":"https://clinicaltrials.gov/study/NCT03093116"},{"label":"TRIDENT-1 (New England Journal of Medicine 2024)","url":"https://doi.org/10.1056/NEJMoa2302299"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer","ros1-positive-nsclc","ntrk-fusion-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["repotrectinib"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":["profile-1001-ros1","nct02568267"],"people":[],"bottlenecks":[],"keyPapers":["paper-trident-1-repotrectinib-nejm-2024"],"journals":[],"dependsOn":[],"notes":["In the registrational phase 1-2 TRIDENT-1 trial, the recommended dose was 160 mg daily for 14 days then 160 mg twice daily. Response occurred in 56 of 71 ROS1 inhibitor-naive patients with ROS1 fusion-positive non-small-cell lung cancer (79 percent, 95 percent confidence interval 68 to 88), with median duration of response 34.1 months and median progression-free survival 35.7 months; in 21 of 56 patients who had had one ROS1 inhibitor and no chemotherapy (38 percent, 25 to 52), median duration of response was 14.8 months and progression-free survival 9.0 months; and in 10 of 17 patients with ROS1 G2032R (59 percent, 33 to 82). Among 426 patients treated at the phase 2 dose the commonest treatment-related events were dizziness (58 percent), dysgeusia (50 percent) and paraesthesia (30 percent), with 3 percent discontinuing (New England Journal of Medicine 2024)."],"nct":"NCT03093116","phase":"1/2","setting":"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)","sponsor":"Turning Point Therapeutics, Inc.","result":"Repotrectinib produced responses in 79 percent of ROS1 inhibitor-naive patients (median progression-free survival 35.7 months) and 38 percent after one ROS1 inhibitor, including 59 percent of those with the G2032R solvent-front mutation.","started":"2017-03-07","startedType":"actual","yearReported":2024,"enrolled":500,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct03093116/","neighbours":{"cancer":[{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"},{"id":"ntrk-fusion-nsclc","kind":"cancer","name":"NTRK fusion-positive non-small-cell lung cancer","route":"/cancers/ntrk-fusion-nsclc/"},{"id":"ros1-positive-nsclc","kind":"cancer","name":"ROS1-positive non-small-cell lung cancer","route":"/cancers/ros1-positive-nsclc/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"repotrectinib","kind":"drug","name":"Repotrectinib","route":"/drugs/repotrectinib/"}],"company":[{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"}],"trial":[{"id":"nct02568267","kind":"trial","name":"Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangeme","route":"/trials/nct02568267/"},{"id":"profile-1001-ros1","kind":"trial","name":"PROFILE 1001 ROS1 expansion cohort","route":"/trials/profile-1001-ros1/"}],"paper":[{"id":"paper-trident-1-repotrectinib-nejm-2024","kind":"paper","name":"TRIDENT-1: repotrectinib in ROS1 fusion-positive non-small-cell lung cancer","route":"/key-papers/paper-trident-1-repotrectinib-nejm-2024/"}]}}