NCT06789848

Ligufalimab and Cadonilimab in Advanced Liver Cancers

Phase II Basket Trial of Ligufalimab (AK117) and Cadonilimab (AK104) in Advanced Hepatobiliary Cancers

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to find out if the combination of Ligufalimab and Cadonilimab are effective in treating advanced hepatobiliary cancers that have failed prior therapy.

Detailed description

The study is an open-label, non-randomized, phase II basket therapeutic clinical trial. To determine the objective response rate of combination ligufalimab and cadonilimab in refractory and advanced hepatocellular carcinoma and biliary tract cancers.

Conditions

• Advanced Hepatocellular Carcinoma
• Refractory Hepatocellular Carcinoma
• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Ligufalimab	Ligufalimab (AK117) 45 mg/kg IV over 120 minutes on Day 1 every 3 weeks
DRUG	Cadonilimab	Cadonilimab (AK104) 10 mg/kg IV over 60 minuets at least 30 minutes after Ligufalimab on Day 1 every 3 weeks

Timeline

• Start date: 2025-02-18
• Primary completion: 2029-05-31
• Completion: 2030-05-31
• First posted: 2025-01-23
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study