A Phase 1/2 Study of CG001419 Tablets in Adult Subjects With Locally Advanced or Metastatic Solid Tumours Harbouring NTRK Gene Abnormalities

The goal of this clinical trial is to learn about the safety of drug CG001419. It also learn if drug CG001419 works to treat in locally advanced/metastatic adult solid tumours with NTRK gene fusions, NTRK gene point mutations, and NTRK gene amplification or over expression. The main questions it aims to answer are: Phase1:To determind the Maximum Tolerated Dose (MTD) and/or Phase 2 Recommended Dose for Phase 2 (RP2D) of CG001419 administered orally to adult subjects with locally advanced/metastatic solid tumours. To establish the safety and tolerability profile of CG001419. Phase2:To evaluate the efficacy of CG001419 in adult subjects with locally advanced or metastatic solid tumours harbouring oncogenic NTRK fusions, mutations, amplifications or over expression. Participants will Receive treatment with CG001419 until disease progression.

NCT Number	NCT07394374
Lead Sponsor	Cullgen (Shanghai),Inc
Conditions	Solid Tumors Harboring NTRK Fusion, NTRK, NTRK Gene Fusion, NTRK Fusion Positive
Enrollment	42 participants
Start Date	2023-06-20
Primary Completion	2030-08-30 (estimated)
Study Completion	2030-08-30 (estimated)
Updated on ClinicalTrials.gov	2026-02-06