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)

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512606-25-00

Acronym

TPX-0005-01

Enrollment

190

Registered

2024-07-19

Start date

2019-12-20

Completion date

Unknown

Last updated

2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

Brief summary

Objective Response Rate (ORR) as assessed by BICR using RECIST Version 1.1, in each subject population expansion cohort of solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

Detailed description

1. Duration of Response (DOR), 2. Time to Response (TTR), 3. Clinical Benefit Rate (CBR), 4. Intracranial Objective Response Rate, 5. CNS Progression-Free Survival (CNS-PFS), 6. Progression-Free Survival (PFS), 7. Overall Survival (OS)

Interventions

DRUGRepotrectinib (TPX-0005)

Eligibility

Sex/Gender

Male

Age

0 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
1. Duration of Response (DOR), 2. Time to Response (TTR), 3. Clinical Benefit Rate (CBR), 4. Intracranial Objective Response Rate, 5. CNS Progression-Free Survival (CNS-PFS), 6. Progression-Free Survival (PFS), 7. Overall Survival (OS)	—

Primary

Measure	Time frame
Objective Response Rate (ORR) as assessed by BICR using RECIST Version 1.1, in each subject population expansion cohort of solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.	—

Countries

Belgium, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026