NCT05382442

A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer

A Phase II Study of AK112 With or Without AK117 for Patients With Metastatic Colorectal Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 254 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is a Phase II study. The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of AK112 with or without AK117 in participants with metastatic colorectal cancer who are not suitable for surgery.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	AK112	AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity
DRUG	AK117	AK117 via intravenous (IV) infusion until disease progression or unacceptable toxicity
DRUG	Oxaliplatin	Oxaliplatin via IV infusion
DRUG	Capecitabine	Capecitabine via oral,The total daily dose was 2000mg/sqm, Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days
DRUG	Irinotecan	Irinotecan via IV infusion
DRUG	Leucovorin	Leucovorin via IV infusion
DRUG	5-fluorouracil	5-fluorouracil via IV infusion

Timeline

• Start date: 2022-06-27
• Primary completion: 2026-05-15
• Completion: 2028-08-12
• First posted: 2022-05-19
• Last updated: 2025-10-14

Locations

4 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study