• Histological and/or cytological diagnosis of advanced/metastatic solid tumors, who have failed standard treatment, or have no standard therapy.

• Have at least one measurable lesion by RECIST v1.1 (Eisenhauer et al., 2009) for solid tumors.

• Men or women ≥18 years old.

• Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) of 0 to 1.

• Life expectancy of ≥ 12 weeks;

• Patients with adequate organ function and the laboratory test criteria specifically defined as follows within 7 days prior to the first dosing.

‣ Hepatic function: AST and ALT ≤ 2.5 x upper limit of normal (ULN); if liver metastases, then ≤ 5 x ULN. Total bilirubin ≤ 1.5 x ULN or ≤ 3 x ULN in the presence of documented Gilbert's Syndrome.

⁃ Albumin ≥3g/dL.

⁃ Coagulation function: International normalized ratio (INR) ≤ 1.5×ULN; APTT≤1.5×ULN.

⁃ Renal function: Creatinine clearance ≥ 60 mL/min (calculated by Cockcroft and Gault equation) (Cockcroft DW, 1976)

⁃ Hematopoietic function (without infusion of blood product, use of G-CSF or other treatments to correct blood count within 14 days): Hemoglobin (HGB) ≥ 90 g/L; Platelet count (PLT) ≥ 100×109/L; Absolute neutrophil count (ANC) ≥ 1.5×109/L;

• Serum pregnancy test (for female of childbearing potential) negative within 7 days prior to first dosing of study treatment. Male and female patients of childbearing potential must agree to use effective methods of contraception from the time of informed consent, throughout the study and for 6 months after the last dose of the investigational product.

• Willing to participate in the clinical trial, understand and sign the informed consent, and comply with the study visits and procedures.