A Phase Ib/II Clinical Study on AK112 Combined or Not Combined With AK119 in pMMR/MSS Colorectal Cancer

This study is an open, multicenter, Ib/II phase clinical trial conducted in China. The research plan is divided into 5 queues. A total of 130-170 subjects were enrolled. Subjects who meet the research criteria will receive treatment with AK119 and AK112 in combination or without chemotherapy, as well as AK112 monotherapy, every two weeks according to the protocol. The research on the first and second cohorts will be conducted first, and at least two lines of microsatellite stabilized colorectal cancer subjects who have failed standard treatment will be enrolled; Subsequently, a third cohort was conducted, which included microsatellite stabilized colorectal cancer subjects who had failed at least two lines of standard treatment; After preliminary confirmation of the safety and efficacy of AK119 combined with AK112 in the first and second cohorts, and determination of the recommended dose of AK119 for subsequent combination chemotherapy, the study of AK119 and AK112 combined chemotherapy in the fourth and fifth cohorts will be conducted. The fourth and fifth cohorts will include participants with advanced first-line microsatellite stable colorectal cancer who have not received systemic treatment.