NCT05846867

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

An Open, Multicenter Phase Ib/II Clinical Study on the Efficacy and Safety of AK119 and AK112, Either in Combination or Not, With Chemotherapy, and AK112 Monotherapy in pMMR/MSS CRC

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	AK119	AK119 IV every 2 weeks.intravenous infusion
DRUG	AK112	AK112 IV every 2 weeks.intravenous infusion
DRUG	Oxaliplatin	Oxaliplatin: 85mg/m2, intravenous infusion
DRUG	Irinotecan	Irinotecan 180mg/m2, intravenous infusion
DRUG	Calcium folinate	Calcium folinate: 400mg/m2, intravenous infusion
DRUG	Fluorouracil	Fluorouracil 400mg/m2, intravenous injection

Timeline

• Start date: 2023-05-08
• Primary completion: 2026-05-08
• Completion: 2026-08-11
• First posted: 2023-05-06
• Last updated: 2026-03-04

Locations

1 site across 1 country: China