Lead Sponsor

Akeso

Collaborators

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

•Histologically proven diagnosis of colorectal adenocarcinoma
•Part1: Subjects who have not previously received any systemic antitumor therapy and who have previously received neoadjuvant or adjuvant therapy, the first detection of recurrence or metastasis should be ≥12 months after the last administration of neoadjuvant or adjuvant therapy
•Part2: Subjects who have previously received systemic therapy including fluorouracil, oxaliplatin, irinotecan, bevacizumab or anti-EGFR antibodies or could not 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

•Known MSI-H(Microsatellite-Instability-High) or dMMR(Mismatch Repair-Deficient)
•Prior treatment with immunotherapy, including immune checkpoint inhibitors , immune checkpoint agonists, immune cell therapy and any treatment targeting tumor immune pathway
•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, during treatment
•Pregnancy or lactation
•Dysphagia