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ACTIVE NOT RECRUITING
NCT05382442
PHASE2

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

Sponsor: Akeso

View on ClinicalTrials.gov

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

Interventions

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

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