SD-101 + Checkpoint Inhibitors for Liver Cancer

Recruiting at4 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: TriSalus Life Sciences, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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).

Research Team

Eligibility Criteria

Adults over 18 with advanced liver or bile duct cancer that's not removable by surgery, who've had one standard treatment but still have growing tumors. They need good blood counts, kidney and liver function, and can't be pregnant or breastfeeding. People with severe allergies to trial drugs or certain medical conditions like active infections are excluded.

Inclusion Criteria

I am a man who can father children and agree to use birth control.

I have a documented FGFR2 or IHD1 mutation and have either been treated for it or refused treatment.

I have liver cancer, have tried one standard treatment, and my cancer is still growing or present.

Exclusion Criteria

I have previously been treated with SD-101.

Patients enrolled in Phase 1b portion of the study

I have brain metastasis that hasn't been treated.

Treatment Details

Interventions

• Ipilimumab (Checkpoint Inhibitor)
• Nivolumab (Checkpoint Inhibitor)
• Pembrolizumab (Checkpoint Inhibitor)
• SD-101 (TLR9 Agonist)

Trial Overview This study tests SD-101 delivered directly into the liver artery using pressure technology alone or combined with immune checkpoint blockers (Nivolumab, Ipilimumab, Pembrolizumab) given through IV. It aims to see how well these treatments work for patients with specific types of liver cancers.

Participant Groups

Group I: SD-101 Experimental Treatment 4 Interventions

Three weekly doses of SD-101 given over two cycles via HAI using the PEDD method of administration.

Who Is Running the Clinical Trial?

TriSalus Life Sciences, Inc.

Lead Sponsor

Trials

10

Recruited

420+