drugset / Trial / NCT05220722

Pressure Enabled Delivery of SD-101 With Checkpoint Blockade for Primary Liver Tumors

NCT05220722 ↗

Phase 1/2 Terminated 23 enrolled TriSalus Life Sciences, Inc.
NaSingle-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2022-03-02
Primary completion
2024-07-31
Completion
2024-07-31

Outcome

Outcome not reported

Stopped (Enrollment): “The decision was made to terminate the study after the completion of Phase 1b enrollment and not proceed with Phase 2. Trial termination was not due to patient safety or data concerns.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody — —
Subject Nivolumab Monoclonal antibody — —
Subject Pembrolizumab Monoclonal antibody — —
Subject SD-101 Oligonucleotide (other) 2 mg Other