A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes

Inclusion Criteria:

• Age ≥ 18 years old at the time of enrolment.

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.

• Expected life expectancy ≥ 3 months.

• Newly diagnosed HR-MDS, according to the 2016 World Health Organization (WHO)classification with the presence of < 20% blasts in bone marrow or peripheral blood;Overall IPSS-R score ≥ 3.5.

• Ability to undergo the study-required bone marrow sample collection procedures.

• Suitable venous access for the study-required blood sampling (i.e., including PK andimmunogenicity).

• Female patients of childbearing age must have negative serum pregnancy test resultsbefore randomization or per region-specific guidance documented in the informedconsent and a negative urine pregnancy test on the day of first dose prior todosing.

• Female patients of childbearing potential having sex with an unsterilized malepartner must agree to use a highly effective method of contraception from thebeginning of screening until 180 days after the last dose of the study treatment.

• Unsterilized male patients having sex with a female partner of childbearingpotential must agree to use an effective method of contraception from the beginningof screening until 180 days after the last dose of study treatment.

Exclusion Criteria:

• MDS evolving from a pre-existing myeloproliferative neoplasm (MPN),myelodysplastic/myeloproliferative neoplasms (MDS/MPN).

• Prior treatment with Cluster of Differentiation (CD) 47 or Signal-regulatory proteinalpha (SIRPα)-targeting agents.

• Concurrently participating in another interventional clinical study, unless it is anobservational (non-interventional) clinical study or during the follow-up period ofan interventional study.

• Patients who previously diagnosed with another malignancy and have any evidence ofresidual disease.

• Known allergy to any component of any study drug; known history of severehypersensitivity to other monoclonal antibodies.

• Patients with any psychiatric or social factor which the investigator deems mayinterfere with the patient's ability to comply with the requirements of the study.

• Patients with current hypertension with systolic blood pressure ≥ 160 mmHg ordiastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy.

• Patients with known cardiopulmonary disease defined as unstable angina, clinicallysignificant arrhythmia, congestive heart failure (New York Heart Association ClassIII or IV), decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolicdisorders.

• Patients who are breastfeeding or plans to breastfeed during the study.

• Other conditions where the investigator considers the patient inappropriate forenrollment.