SD-101 + Checkpoint Inhibitors for Liver Cancer

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: TriSalus Life Sciences, Inc.

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Brain metastasis, Hepatitis, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 6

89 Participants Needed

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).

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1b

Participants receive 2 cycles of SD-101 with escalating doses, each cycle consisting of 3 weekly infusions separated by one month

10 weeks

6 visits (in-person)

Treatment Phase 2

Participants receive the selected SD-101 dose with systemic single- or double-agent checkpoint blockade

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Ipilimumab
• Nivolumab
• Pembrolizumab
• SD-101

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.

Ipilimumab is already approved in United States, European Union for the following indications:

Approved in United States as Yervoy for:

• Advanced melanoma
• Stage III unresectable melanoma
• Stage IV metastatic melanoma

Approved in European Union as Yervoy for:

• Advanced melanoma
• Stage III unresectable melanoma
• Stage IV metastatic melanoma

Who Is Running the Clinical Trial?

TriSalus Life Sciences, Inc.

Lead Sponsor

Trials

10

Recruited

420+