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A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer
Sponsor: Akeso
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.
Official title: A Phase II Study of AK112 With or Without AK117 for Patients With Metastatic Colorectal Cancer
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
254
Start Date
2022-06-27
Completion Date
2028-08-12
Last Updated
2025-10-14
Healthy Volunteers
No
Conditions
Interventions
AK112
AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity
AK117
AK117 via intravenous (IV) infusion until disease progression or unacceptable toxicity
Oxaliplatin
Oxaliplatin via IV infusion
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
Irinotecan
Irinotecan via IV infusion
Leucovorin
Leucovorin via IV infusion
5-fluorouracil
5-fluorouracil via IV infusion
Locations (4)
Summit Therapeutics Research Site
Los Angeles, California, United States
Summit Therapeutics Research Site
Murrieta, California, United States
Summit Therapeutics Research Site
Fairfax, Virginia, United States
The Sixth Hospital,Sun Yat-sen University
Guanzhou, Guangdong, China