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)

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506464-14-00

Acronym

TPX-0005-07

Enrollment

Registered

2024-02-07

Start date

2023-06-29

Completion date

Unknown

Last updated

2025-08-01

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

ORR as determined by BICR

Detailed description

DOR, TTR and CBR, Intracranial tumor response, Central nervous system (CNS) progression-free survival (CNS-PFS) in subjects with measurable brain metastases, PFS and OS, PK parameters, Type, incidence, severity, timing, seriousness, and relatedness of AEs and laboratory abnormalities

Interventions

DRUGRepotrectinib (TPX-0005)

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
ORR as determined by BICR	—

Secondary

Measure	Time frame
DOR, TTR and CBR, Intracranial tumor response, Central nervous system (CNS) progression-free survival (CNS-PFS) in subjects with measurable brain metastases, PFS and OS, PK parameters, Type, incidence, severity, timing, seriousness, and relatedness of AEs and laboratory abnormalities	—

Countries

Denmark, France, Italy, Spain

Outcome results

None listed

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