University of Texas Southwestern Medical Center
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.
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.
Inclusion Criteria: 1. Histological confirmation of specific disease -Cohort A (HCC): Patient must have a diagnosis confirmed by histology or clinically by the American Association for the Study of Liver Diseases (AASLD) criteria in patients with cirrhosis. Known fibrolamellar HCC will be excluded. * Cohort B (BTC, biliary tract cancers): Patients must have histologically confirmed biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gall bladder cancers). Patients with combined HCC-cholangiocarcinoma may be enrolled in Cohort B. 2. Locally…
Ligufalimab (AK117) 45 mg/kg IV over 120 minutes on Day 1 every 3 weeks
Cadonilimab (AK104) 10 mg/kg IV over 60 minuets at least 30 minutes after Ligufalimab on Day 1 every 3 weeks
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