Phase I Study of SHR-2002 + SHR-1316 in Patients With Advanced Malignant Tumors

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;