Study of AK119 and AK 112 With or Without Chemotherapy for Colorectal Cancer Patients

Colorectal Cancer Clinical Trial

Official title: A Phase Ib/II Study of AK112 and AK119 in Combination With or Without Chemotherapy in the Treatment of Patients With Advanced Microsatellite Stabilized (pMMR/MSS) Colorectal Cancer

Status Not yet recruiting

Clinical Trial Summary

This is a phase Ib/II clinical study on AK119 and AK112 combined with or without chemotherapy in advanced microsatellite stabilized (pMMR/MSS) colorectal cancer

Clinical Trial Description

The study included the screening period (no more than 28 days after the subject signed the informed consent form to the first medication), the treatment period (until the investigator assessed that there was no clinical benefit, intolerable toxicity or withdrew the informed consent, whichever occurred first) and the follow-up period (including safety follow-up, disease progress follow-up and survival follow-up). Subjects will be screened and evaluated within 28 days before the first medication to determine whether they meet the study conditions. During the screening period, tumor samples of the subjects need to be collected. Subjects who meet the study conditions will be treated according to the study medication plan until the following conditions occur: the investigator judges that the subject cannot continue to benefit, there is intolerable toxicity, there is a concomitant disease that affects further treatment, the investigator decides, the subject withdraws his informed consent or the treatment needs to be terminated for other reasons specified in the plan (whichever occurs first). The investigator regularly evaluated the tumor response of all subjects according to RECIST 1.1 standard. Subjects were evaluated once every 6 weeks (± 7 days) within 54 weeks after enrollment, and then once every 9 weeks (± 7 days). For subjects undergoing treatment, their clinical decisions are based on the tumor response evaluated by the researchers ;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT05846867
• Study type: Interventional
• Source: Akeso
• Contact: Zhifang Yao, MD
• Phone: 0760-8987 3999
• Email: clinicaltrials@akesobio.com
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: May 10, 2023
• Completion date: July 10, 2025