A Phase I/II Study of TJ004309 for Advanced Solid Tumor

Inclusion Criteria: * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1 * In the dose-escalation phase, subjects with advanced solid tumors that are histologically or cytologically confirmed to be unresectable or have metastasized, subjects with standard treatment failure or intolerance (disease progression, or inability to tolerate chemotherapy, targeted therapy, etc.), or subjects without effective treatment. * Synchronous dose expansion (will base on dose-escalation phase) * At least one measurable disease by modified RECIST 1.1 for immune based therapeutics V1.1 * Expected survival ≥ 3 months * Adequate organ function as defined by the following criteria: * Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 times upper limit of normal (ULN) * Total serum bilirubin ≤ 1.5 times the ULN * Absolute neutrophil count (ANC) ≥ 1.5 ×109/ L * Platelets ≥ 100×109/ L without transfusion support within 28 days prior to study treatment * Hemoglobin ≥ 9.0 g/dL without transfusion support within 14 days prior to study treatment * Serum creatinine ≤ 1.5 times the ULN or Creatinine clearance \> 30 mL/min by Cockcroft-Gault formula * International normalized ratio (INR) in normal range * Serum pregnancy test must be negative for childbearing female prior to study treatment * The man have reproductive ability or childbearing female (refers to men and women not on birth control operation, and the menopause women), mu…