Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of ASKC202 With or Without ASK120067

Who may be able to join

• Willing and able to provide signed and dated informed consent;
• Aged 18 years old or more, male or female;
• Part 1 (Monotherapy Dose-Escalation) and Part 3 (Monotherapy Expansion): the subjects with locally advanced or metastatic solid tumors for whom no standard therapy regimens are available currently or who are intolerable to standard therapy regimens; Part 3: the subjects with MET gene amplification or protein overexpression; Part 3 cohort 1: histologically or cytologically confirmed unresectable locally advanced or metastatic NSCLC.
• 4）Part 2:(Combination Therapy Dose-Escalation):a)histologically or cytologically confirmed unresectable locally advanced or metastatic NSCLC;b)Histologically confirmed EGFR sensitizing mutation (Ex19del or L858R).；c)Disease progression following treatment with a third-generation EGFR TKI, or treatment with a first-/second-generation EGFR-TKI with confirmed T790M-negative status upon progression; d)MET gene amplification or protein overexpression.
• 5) Part 4:(Combination Therapy Dose-Expansion):a)histologically or cytologically confirmed unresectable locally advanced or metastatic NSCLC;b)Histologically confirmed EGFR sensitizing mutation (Ex19del or L858R).；c)MET gene amplification or protein overexpression.
• 6) At least one measurable lesion (based on the RECIST 1.1 criterion) (this article is only for the dose expansion phase); 7) ECOG score 0~1; 8) Expected survival time ≥ 3 months; 9) Major organ function is essentially normal (no transfusions, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), or other medically supportive care have been received in the 14 days prior to the administration of the study drug), and laboratory tests during the screening period meet the following criteria: system Laboratory test values haematology Absolute neutrophil count ≥1.5 ×109/L platelet ≥90×109/L haemoglobin ≥90g/L kidney Serum creatinine or Creatinine clearance (CrCl). ≤ 1.5 × ULN or
• ≥60 mL/min (estimated from the Cockcroft-Gault formula) liver Total bilirubin ≤1.5 × ULN or ≤2 × ULN (for patients with liver cancer or liver metastases). AST(SGOT) and ALT (SGPT). ≤2.5 × ULN or ≤5 × ULN (for patients with liver cancer or liver metastases). Coagulation (no anticoagulation was received in the 7 days prior to the administration of the study drug).
• International normalized ratio (INR) or prothrombin time (PT). ≤1.5 × ULN Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN 10) Women of childbearing age must have a pregnancy test (serum or urine) within 7 days of enrolling and have a negative result, or meet one of the following criteria to prove that there is no risk of pregnancy: a Postmenopausal is defined as amenorrhea at least 12 months after age >50 years and discontinuation of all exogenous hormone replacement therapy; b Women younger than 50 years of age who are considered postmenopausal if they have been amenorrhea for 12 months or more after stopping all exogenous hormone therapy, and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within the laboratory reference values for postmenopausal; c Previously undergone irreversible sterilization procedures, including hysterectomy, bilateral ovarian resection, or bilateral salping, with the exception of bilateral tubal ligation; 11) Women of childbearing age should use strict contraceptive contraception throughout trial 7 and within 3 months after the last dose of the test drug; male subjects should use strict contraception throughout the trial period and for 6 months after the last dose of the test drug and no sperm donation; 12) The patient understands the purpose and steps of the trial, voluntarily participates in the trial, and signs a written informed consent form; 13) Patients have good comprehension, are able to follow protocol requirements and can cooperate with investigators in this trial.