drugset / Trial / NCT05382442

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

NCT05382442

Phase 2 Active not recruiting 254 enrolled Akeso Summit Therapeutics · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-06-27
Primary completion
2026-05-15
Completion
2028-08-12

Drugs

EvaluationDrugModalityDoseRoute
Subject AK117 Monoclonal antibody Intravenous
Subject Capecitabine Small molecule 2000 mg/m2 Oral
Subject Irinotecan Small molecule 150 mg/m2 Intravenous
Subject Irinotecan Small molecule 165 mg/m2 Intravenous
Subject Ivonescimab Monoclonal antibody Intravenous
Subject Leucovorin Small molecule 400 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous
Subject fluorouracil Small molecule 2800 mg/m2 Intravenous

Indications