# A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

Source: https://onco.cc/trials/nct03093116/  
OnCo record `nct03093116` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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).

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Also known as: TRIDENT-1
- Tags: pipeline; ctgov-ingest
- Registry id: 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.
- Enrolled: 500
- 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.

## 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).

## Sources

- ClinicalTrials.gov NCT03093116: https://clinicaltrials.gov/study/NCT03093116
- TRIDENT-1 (New England Journal of Medicine 2024): https://doi.org/10.1056/NEJMoa2302299

## Connected records

- cancers: [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Metastatic cancer (cancer that has spread)](https://onco.cc/cancers/metastatic-cancer/), [NTRK fusion-positive non-small-cell lung cancer](https://onco.cc/cancers/ntrk-fusion-nsclc/), [ROS1-positive non-small-cell lung cancer](https://onco.cc/cancers/ros1-positive-nsclc/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Repotrectinib](https://onco.cc/drugs/repotrectinib/)
- companies: [Bristol Myers Squibb](https://onco.cc/companies/bms/)
- trials: [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](https://onco.cc/trials/nct02568267/), [PROFILE 1001 ROS1 expansion cohort](https://onco.cc/trials/profile-1001-ros1/)
- key papers: [TRIDENT-1: repotrectinib in ROS1 fusion-positive non-small-cell lung cancer](https://onco.cc/key-papers/paper-trident-1-repotrectinib-nejm-2024/)

---
JSON: https://onco.cc/api/v1/entities/nct03093116.json