All patients will receive 2 cycles of SD-101. Each cycle consists of 3 consecutive weekly infusions and Cycles 1 and 2 are separated by one month. Escalating doses of SD-101 will be administered alone (Cohort A), together with pembrolizumab (Cohort B), and together with combined ipilimumab and nivolumab (Cohort C). Cohort B will begin dosing at the minimum anticipated biological effect level (MABEL (2mg SD-101)). Cohort C will begin one dose level below the MTD or optimal dose from Cohort B to optimize safety when adding CPI to SD-101.~Following determination of the recommended MTD or optimal dose of SD-101 and which checkpoint inhibitor (CPI) regimen(s) are tolerated, the study will progress to Phase 2. Patients in Phase 2 will receive the SD-101 dose selected from Phase 1b together with systemic single- or double-agent checkpoint blockade. The choice of single- or double-agent CPI therapy together with SD-101 for Phase 2 will consider safety data in addition to response rates from Cohorts B and C in Phase 1b.
This is an Open-label, Phase 1b/2 Study of the Pressure-Enabled Hepatic Artery Infusion (HAI) of SD-101, a TLR9 agonist, Alone or in Combination with Intravenous Checkpoint Blockade in Adults with Hepatocellular Carcinoma (HCC) and Intrahepatic Cholangiocarcinoma (ICC).