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

Inclusion Criteria:

1. Able to provide written and signed informed consent
2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
3. Life expectancy ≥12 weeks
4. Females of childbearing potential and non-sterilized males who are sexually active must use an effective method of contraception from screening until 120 days after final dose of investigational product or women of non-childbearing potential.
5. Willing to receive blood transfusion(s) when so advised by the investigator.
6. Adequate organ function.
7. Subjects must have a histologically or cytologically confirmed advanced solid tumor that is refractory or relapsed to the current standard therapies or which no effective standard therapy is available.
8. At least 1 measurable lesion according to RECIST v1.1

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.