A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer

Inclusion Criteria:

• Metastatic or locally advanced, histologically documented TNBC characterized byabsence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), andprogesterone receptor (PR) expression

• No prior chemotherapy or targeted systemic therapy for inoperable locally advancedor metastatic TNBC

• Eligible for taxane monotherapy

• A representative formalin-fixed, paraffin-embedded tumor specimen in paraffinblocks, or at least 5 unstained slides with an associated pathology reportdocumenting ER, PR, and HER2 negativity.

• Eastern Cooperative Oncology Group performance status of 0 or 1

• Measurable disease as defined by RECIST v1.1

• Adequate hematologic and end-organ function

Exclusion Criteria:

• Known central nervous system (CNS) disease, except for asymptomatic CNS metastases

• Leptomeningeal disease

• Pregnancy or lactation

• History of autoimmune disease

• Prior allogeneic stem cell or solid organ transplantation

• Positive test for human immunodeficiency virus

• Active hepatitis B or hepatitis C

• Receipt of a live, attenuated vaccine within 30 days prior to randomization, duringtreatment