NCT04556253

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

A Multicenter, Open-Label, Phase II Study of Anti-PD-1/CTLA-4 Bispecific Antibody AK104 in the Perioperative Treatment of Locally Advanced Microsatellite Instability/Mismatch Repair Protein-Deficient Gastric and Colorectal Cancers

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer

Interventions

Type	Name	Description
DRUG	AK104	Subjects will receive AK104 by intravenous administration.

Timeline

• Start date: 2024-02-28
• Primary completion: 2026-12-01
• Completion: 2028-12-01
• First posted: 2020-09-21
• Last updated: 2026-01-02

Locations

1 site across 1 country: China