drugset / Trial / NCT05220722
Pressure Enabled Delivery of SD-101 With Checkpoint Blockade for Primary Liver Tumors
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | — | — |
| Subject | Nivolumab | Monoclonal antibody | — | — |
| Subject | Pembrolizumab | Monoclonal antibody | — | — |
| Subject | SD-101 | Oligonucleotide (other) | 2 mg | Other |