A Phase 1b/2 Pressure Enabled Regional Immuno-Oncology Study of Hepatic Arterial Infusion of SD-101 with Systemic Checkpoint Blockade for Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma

The purpose of this study is to determine the safety and best dose of SD-101 given by hepatic artery infusion (HAI, a method of putting medication directly into your liver) using Pressure- Enabled Drug Delivery (PEDD) alone or in combination with either pembrolizumab or in combination with nivolumab and ipilimumab. SD-101 works by limiting the expression, or present of, TLR9 in your body, which when present in large amounts, helps your tumor to grow. The study also aims to find out what effects (both good and bad) SD-101 given by HAI with PEDD has on you and your cancer when given alone or when in combination with pembrolizumab or when given in combination with nivolumab and ipilumumab. Nivolumab, pembrozilumb and ipilimumab have been previously studied in humans and are currently approved by the United States Food and Drug Administration (FDA) for the treatment of certain cancer types, including HCC. They have not previously been studied in combination with SD-101.

Are you Eligible? (Inclusion Criteria)

• You must be 18 years of age or older. -You must have been diagnosed with intreahepatic cholagiocarcinoma (ICC) or hepatocellular cholangiocarcinoma (HCC). - You must have be comfortable with receiving the study drug in the vein (intravenously).