Repotrectinib (TPX-0005)
Sponsors
Bristol-Myers Squibb Services Unlimited Company, Turning Point Therapeutics Inc., Medica Scientia Innovation Research S.L., Medical University Of Vienna, Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer, Groupe Français de Pneumo-Oncologie, Turning Point Therapeutics, Inc.
Conditions
Advanced Solid TumorsAdvanced solid tumorsLocally Advanced Solid TumorMetastatic Solid TumorNon small cell lung cancer (NSCLC)ROS1-positive non-small cell lung cancer (NSCLC) with active brain metastasisStage III/IV non-small-cell lung cancer (NSCLC) harboring an ROS1 gene rearrangement
Phase 1
A Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Repotrectinib in Advanced Cancer Patients
WithdrawnNCT05828277
Start: 2022-07-28End: 2025-12-31Updated: 2023-09-26
A Phase 1/2, Open-label, Safety, Tolerability, Pharmacokinetics, and Antitumor
Activity Study of Repotrectinib in Pediatric and Young Adult Subjects
with Advanced or Metastatic Malignancies Harboring ALK, ROS1, or
NTRK1-3 Alterations (CARE)
RecruitingCTIS2023-506464-14-00
Start: 2023-06-29Target: 20Updated: 2025-08-01
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)
RecruitingCTIS2024-512606-25-00
Start: 2019-12-20Target: 190Updated: 2025-12-01
Phase 2
OPEN-LABEL PHASE II EFFICACY STUDY OF REPOTRECTINIB IN FRAIL (PS ≥2) AND /OR ELDERLYPATIENTS WITH ROS1-REARRANGED ADVANCED NSCLC
RecruitingCTIS2023-509073-23-00
Start: 2024-10-01Target: 30Updated: 2025-08-22
A phase II study assessing safety and efficacy of REPotrectinib in ROS1-positive non-small cell lung cancer patients with active brain mEtastasis (The REPOSE study)
RecruitingCTIS2023-508112-35-00
Start: 2025-04-15Target: 20Updated: 2025-12-12