Subjects must meet all the following criteria to be eligible for enrollment into the study:  Ability to understand and voluntarily agrees to participate by giving written informed consent for the study; Male or female aged ≥18 years at the time of signing the ICF; Histopathologically or cytologically documented advanced or metastatic malignancies and failed or intolerable to previous standard therapy, has no available standard of care therapy or refused standard therapy; An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1 (Appendix 2); Female and male patients of reproductive potential must agree to use highly effective contraception during the study treatment period and within 6 months after the last investigational drug administration.  Subjects who meet any of the following criteria will be excluded from the study:  Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with tumor-related pain that cannot be controlled as determined by the investigator. Systemic anti-tumor therapy within 28 days prior to the first dose of the study treatment History of autoimmune diseases, except for Type 1 diabetes (blood glucose can be controlled by insulin therapy) History of clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study treatment. Known history of serious allergic reactions to the investigational product or its main ingredients; History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation;