OncRef

Clinical Trial: NCT03093116

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

Status:

RECRUITING

Phase:

Phase 1

Lead Sponsor:Turning Point Therapeutics, Inc.
Information Provided By:Turning Point Therapeutics, Inc.
Last Update Posted:2026-05-27

Study Overview

Brief 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.

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)

Conditions

Locally Advanced Solid Tumors, Metastatic Solid Tumors

Intervention / Treatment

  • Drug: Oral repotrectinib (TPX-0005)

Other Study ID Numbers

  • CA127-1024
  • CA127-1024
  • TPX-0005-01

Start Date (Actual)

2017-03-07

Primary Completion Date (Estimated)

2028-02-29

Study Completion Date (Estimated)

2028-02-29

Enrollment (Estimated)

500

Study Type

Interventional

Phase

Phase 1, Phase 2