NCT05220722

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: TriSalus Life Sciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Hepatocellular Carcinoma
• Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	SD-101	SD-101 doses will be delivered via HAI using the PEDD method of administration.
BIOLOGICAL	Pembrolizumab	During Phase 1b, Cohort B, pembrolizumab will be administered together with SD-101.
BIOLOGICAL	Nivolumab	During Phase 1b, Cohort C, nivolumab will be administered together with ipilimumab and SD-101.
BIOLOGICAL	Ipilimumab	During Phase 1b, Cohort C, ipilimumab will be administered together with nivolumab and SD-101.

Timeline

• Start date: 2022-03-02
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2022-02-02
• Last updated: 2025-10-23

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study