drugset / Trial / NCT04556253

AK104 in Locally Advanced MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer

NCT04556253 ↗

Phase 2 Active not recruiting 47 enrolled Peking University
NaSingle-groupOpen-labelTreatment

Summary

This is a single-arm, multicenter phase II clinical study. The aim is to evaluate the safety, tolerability, and anti-tumor activities of AK104(a PD-1/CTLA-4 bispecific antibody) in MSI-H/dMMR locally advanced gastric adenocarcinoma and colorectal cancer during the perioperative period.Eligible patients will receive AK104 for three cycles before surgery and at most 6 months after surgery. The primary endpoint is the pathological complete response rate.

Timeline

Start
2024-02-28
Primary completion
2026-12
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cadonilimab Monoclonal antibody — Intravenous

Indications