Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT05846867
Brief Summary:
This is an open label, multicenter Phase Ib/II clinical study on the efficacy and safety of AK119 and AK112 in combination with or without chemotherapy, and AK112 monotherapy in pMMR/MSS CRC
Detailed Description:
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.
Study:
NCT05846867
Study Brief:
Protocol Section:
NCT05846867