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

NCT05220722 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-10-23

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • TriSalus Life Sciences, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-02
Primary Completion
2024-07-31
Completion
2024-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05220722 on ClinicalTrials.gov