A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer

Inclusion Criteria:

• Histologically proven diagnosis of colorectal adenocarcinoma

• Part1: Subjects who have not previously received any systemic antitumor therapy andwho have previously received neoadjuvant or adjuvant therapy, the first detection ofrecurrence or metastasis should be ≥12 months after the last administration ofneoadjuvant or adjuvant therapy

• Part2: Subjects who have previously received systemic therapy includingfluorouracil, oxaliplatin, irinotecan, bevacizumab or anti-EGFR antibodies or couldnot tolerate or have contraindications to standard treatment

• Eastern Cooperative Oncology Group performance status of 0 or 1

• Measurable disease as defined by RECIST v1.1

• Adequate hematologic and organ function

Exclusion Criteria:

• Known MSI-H(Microsatellite-Instability-High) or dMMR(Mismatch Repair-Deficient)

• Prior treatment with immunotherapy, including immune checkpoint inhibitors , immunecheckpoint agonists, immune cell therapy and any treatment targeting tumor immunepathway

• 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

• Pregnancy or lactation

• Dysphagia