NCT07394374

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

A Phase 1/2, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CG001419 Tablets in Adult Patients With Locally Advanced/Metastatic Solid Tumors Harboring NTRK Gene Fusions, Mutations, or Amplification/Over Expression.

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Cullgen (Shanghai),Inc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is an open-label, multicentre, first-in-human (FIH) clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumour efficacy of CG001419 as an oral monotherapy in subjects with locally advanced or metastatic solid tumours. The study comprises two parts: a dose-finding phase (including dose escalation and dose expansion) and an indication expansion phase , as detailed in the study design diagram . Both the dose-finding and indication expansion phases will include a screening period (Days -28 to 1) and a treatment period (from Day 1 of study drug administration).Both the Dose Exploration Phase and the Indication Expansion Phase will include a Screening Period (Days -28 to -1), a Treatment Period (commencing on Day 1 of study drug administration and continuing until the earliest occurrence of disease progression, occurrence of intolerable toxicity, initiation of new antitumour therapy, loss to follow-up, withdrawal of informed consent, death, or sponsor discontinuation), and a follow-up period (encompassing safety and survival follow-up). The study will enrol adult subjects with locally advanced or metastatic solid tumours who have failed standard therapy or are unsuitable for standard treatment. The dose-escalation phase has no NTRK gene/TRK protein status requirements, though tumours with oncogenic NTRK/TRK mutations will be prioritised. The dose-expansion and indication-expansion phases will enrol tumours with oncogenic NTRK/TRK mutations (confirmed by central laboratory testing of tumour tissue or peripheral blood). The indication expansion phase will assign adult subjects with locally advanced or metastatic solid tumours who have failed standard therapy or are unsuitable for standard therapy to one of four distinct cohorts based on NTRK/TRK alteration status and prior exposure to TRK tyrosine kinase inhibitors (TKIs).

Conditions

• Solid Tumors Harboring NTRK Fusion
• NTRK
• NTRK Gene Fusion
• NTRK Fusion Positive

Interventions

Type	Name	Description
DRUG	CG001419 tablets	For QD administration, a single dose was given each morning. For BID administration, two doses were given 12 hours apart, one in the morning and one in the evening. Treatment Schedule:Repeated dosing was administered in 28-day treatment cycles.

Timeline

• Start date: 2023-06-20
• Primary completion: 2030-08-30
• Completion: 2030-08-30
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

6 sites across 1 country: China