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

1. Age ≥18 when signing the informed consent form, regardless of gender. 2. The estimated survival time is ≥3 months. 3. Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors that have failed, are intolerant to, or have no available standard therapy. 4. 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. 5. The Indication Expansion Phase will enroll subjects into the following three cohorts, with respective entry criteria: Cohort 1: Subjects with a confirmed oncogenic NTRK fusion who have not received prior treatment with entrectinib, larotrectinib, and/or other selective TRK-TKIs. Cohort 2: Subjects with a confirmed oncogenic NTRK fusion who have experienced treatment failure with entrectinib, larotrectinib, and/or other selective TRK-TKIs. Cohort 3: Subjects with confirmed non-fusion NTRK alterations, including point mutations, gene amplification, or TRK protein overexpression, and a positive pan-TRK immunohistochemistry (IHC) result, regardless of prior TRK-TKI treatment. Notes:1)NTRK point mutations include Single Nucleotide Variants (SNVs) and Insertion-Deletions (InDels). 2)Positive pa…