RecruitingPhase 1Phase 2NCT07394374

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.


Sponsor

Cullgen (Shanghai),Inc

Enrollment

42 participants

Start Date

Jun 20, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CG001419 tablets for people with ntrk, ntrk fusion positive, and other related conditions. The study is currently recruiting participants at 6 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCG001419 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.


Locations(6)

The Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

West China Hospital of Sichuan University

Chengdu, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, China

The Sir Run Run Shaw Hospital, Affiliated to Zhejiang University School of Medicine

Hangzhou, China

Zhejiang Provincial Cancer Hospital

Hangzhou, China

Shanxi Provincial Cancer Hospital

Taiyuan, China

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NCT07394374