A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 as Monotherapy or in Combination With AK104

Exclusion Criteria

• •1. Concurrent enrollment in another clinical study excluding observational trials
• •2. Prior malignancy active within the previous 3 years except for the tumor for which a subject is enrolled in the study
• •3. Active brain/central nervous system (CNS) metastases
• •4. Active infections requiring systemic therapy within 2 weeks prior to the first dose of investigational product.
• •5. Known history of HIV.
• •6. Known active hepatitis B or C infections
• •7. Active or prior documented autoimmune disease that may relapse.
• •8. History of interstitial lung disease or non-infectious pneumonitis, except those induced by radiation therapies.
• •9. History of defects in RBC production, or hemoglobin production or metabolism
• •10. Patients with clinically significant cardio-cerebrovascular disease.
• •11. History of severe hypersensitivity reactions to other mAbs.
• •12. History of organ transplantation.
• •13. Receiving any anticancer therapy targeting the CD47/SIRPα ; Anticancer small molecule targeted agent within 2 weeks prior to the first dose of the investigational product; Anticancer mAbs within 6 weeks prior to the first dose of investigational product or 5 half-lives (whichever is lesser); Other anticancer therapy within 4 weeks prior to the first dose of the investigational product;
• •14. Subjects with a condition requiring systemic treatment with either corticosteroid (\>10 mg daily doses)) or other immunosuppressive medications within 2 weeks prior to the first dose of investigational product.
• •15. Received a live attenuated vaccine within 4 weeks prior to the first dose of investigational product.