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.
Age ≥18 when signing the informed consent form, regardless of gender.
The estimated survival time is ≥3 months.
Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors that have failed, are intolerant to, or have no available standard therapy.
Dose Escalation Phase: While testing for NTRK/TRK status is not mandatory, enrollment priority will be accorded to patients whose tumors harbor oncogenic NTRK/TRK alterations. Dose Expansion and Indication Expansion Phases: Enrollment eligibility is contingent upon the confirmation of oncogenic NTRK/TRK alterations, as ascertained through tumor tissue or peripheral blood testing.
None
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Treatment groupsSee each treatment group below.