CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 500 target
Drug / intervention
Oral repotrectinib (TPX-0005)drug
Likely dose
Not stated in record
Key inclusion· 12
  • ✓Histologically or cytologically confirmed locally advanced or metastatic solid tumor with ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement (Phase 1)
  • ✓ROS1 or NTRK1-3 gene fusion confirmed by tissue-based local testing with central lab confirmation (Phase 2)
  • ✓ECOG Performance Status 0-1
  • ✓Age ≥18 years (Phase 1) or ≥12 years (Phase 2)
Key exclusion· 14
  • ✕Concurrent participation in another therapeutic clinical trial
  • ✕Symptomatic brain metastases or leptomeningeal involvement
  • ✕History of previous cancer within 2 years (except skin cancer or resected in situ carcinoma)
  • ✕Major surgery within 4 weeks of treatment start

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03093116
NCT03093116Phase 2RecruitingOn Track
Long Recruiting
CompareCT.gov

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)

Turning Point Therapeutics, Inc.·interventional·Posted Mar 28, 2017·Updated May 27, 2026

In Brief

A Phase 2 clinical trial evaluating Oral repotrectinib (TPX-0005) for Locally Advanced Solid Tumors and Metastatic Solid Tumors. Currently recruiting, targeting 500 participants across 165 sites in 19 countries.

Detailed Summary

Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction. Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLocally Advanced Solid Tumors, Metastatic Solid Tumors
CountriesAustralia, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Netherlands, Poland, Singapore, South Korea, Spain, Taiwan, United Kingdom, United States
CollaboratorsZai Lab (Shanghai) Co., Ltd.

Timeline

Phase 2Recruiting
201720182019202020212022202320242025202620272028
First PostedMar 28, 2017
Enrollment StartMar 7, 2017
Primary CompletionFeb 29, 2028
TodayJul 2, 2026
Enrollment to primary: 11.0 yearsPosted 9.3 years agoPrimary completion in 1.7 years

Interventions

Oral repotrectinib (TPX-0005)drug

Oral repotrectinib (TPX-0005) capsules.