Study of IBI318 in Participants With Advanced Malignancies

Exclusion Criteria

• •1. Previous exposure to immunotherapy including but not limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anti-tumor vaccine
• •2. Participation in another interventional clinical study, an observational (non-interventional) clinical study, or a follow-up phase of an interventional study
• •3. Receive last anti-tumor treatment within 4 weeks prior to the first dose of study drug
• •4. Use of immunosuppressive drugs within 4 weeks prior to the first dose of study drug
• •5. Require long-term steroid therapy or any other form of immunosuppressive therapy not including inhaled steroids
• •6. Toxicity (excluding hair loss or fatigue) caused by previous antitumor therapy that did not recover to NCI CTCAE v 5.0 level 0-1 within 4 weeks prior to the first dose of study drug
• •7. Received major surgery or has unhealed wounds, ulcers, or fractures within 4 weeks prior to the first dose of study drug
• •8. Expect to receive other anti-tumor treatments during study (allowing palliative radiotherapy)
• •9. History of infectious pneumonitis that required steroids or has current pneumonitis
• •10. Known active untreated CNS metastases and/or spinal cord compression and/or cancerous meningitis, or with a history of soft meningeal cancer
• •11. Active autoimmune disease that has required systemic treatment in past 2 years
• •12. Known active Hepatitis B or Hepatitis C virus
• •13. Uncontrolled concomitant diseases or neurological, psychiatric/social conditions that could affect study compliance, significantly increase the risk of adverse events, or affect the participant's ability to provide written informed consent
• •14. Known history of human immunodeficiency virus (HIV) infection
• •15. Known history of active tuberculosis (TB) or active syphilis
• •16. History of allogeneic organ transplantation or hematopoietic stem cell transplantation
• •17. Accompanied by uncontrolled third interstitial fluids requiring repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc.
• •18. Known severe allergic reactions to other monoclonal antibodies or are allergic to any IBI318 formulation component
• •19. Female subjects who are pregnant or lactating