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

23 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new combination of treatments for liver cancer, specifically SD-101 (an experimental treatment) and checkpoint inhibitors such as Ipilimumab, Nivolumab, and Pembrolizumab. The main goal is to determine how effectively these treatments work together against advanced liver cancers, including hepatocellular carcinoma and intrahepatic cholangiocarcinoma. Ideal candidates for this trial have liver cancer that has progressed despite one prior standard treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.

What prior data suggests that the Pressure-Enabled Hepatic Artery Infusion of SD-101 is safe for liver cancer patients?

Research has shown that SD-101, when injected directly into the liver artery, was well-tolerated by patients in earlier studies. Patients experienced beneficial immune responses without severe side effects. When combined with other treatments like pembrolizumab, some patients experienced more serious side effects, known as grade 3 or 4, though these were uncommon.

For the checkpoint inhibitors—ipilimumab, nivolumab, and pembrolizumab—previous research indicates they are generally well-tolerated. However, like all medications, they can cause side effects. These may include tiredness, skin rash, or more serious issues, but severe reactions are not typical.

These treatments remain under study, so while they show promise, it's important to weigh both the benefits and risks. Prospective trial participants should discuss these details with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about SD-101 for liver cancer because it offers a novel approach compared to existing treatments like Sorafenib or Lenvatinib. Unlike these standard therapies that generally target cancer cell growth or blood vessel formation, SD-101 is administered directly into the liver using hepatic artery infusion (HAI) via the Pressure-Enabled Drug Delivery (PEDD) method. This targeted delivery approach could potentially increase the concentration of the drug in the tumor, enhancing its effectiveness while minimizing systemic side effects. Additionally, SD-101 works by stimulating the body's immune response, potentially offering a new mechanism to combat liver cancer.

What evidence suggests that this trial's treatments could be effective for liver cancer?

Research has shown that SD-101, a drug that boosts the immune system, may help treat liver cancers such as hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC). SD-101 encourages the immune system to attack cancer cells. In this trial, participants will receive SD-101, and studies are also examining its effectiveness when combined with other cancer drugs like ipilimumab, nivolumab, or pembrolizumab. Early results suggest that delivering SD-101 directly to the liver can effectively target tumors. While detailed results are still being gathered, the mechanism of SD-101 and the initial findings are promising for treating liver cancer. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05220722

Pressure Enabled Delivery of SD-101 With Checkpoint ... 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 ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2622

PERIO-02: Phase 1b pressure enabled regional immuno- ... Median age was 64.5. Only 1 pt was treatment-naïve; 4, 2L (17%); 5, 3L (22%); 14, > 4L (61%). 26% pts had > 10 liver tumors. 3 pts (13%) ...

3. withpower.com withpower.com/trial/cryoablation-sd-101-for-liver-cancer-60ecd

Cryoablation + SD-101 for Liver Cancer In a study of 78 patients with unresectable hepatocellular carcinoma (HCC), the combination of cryoablation and sorafenib showed promising efficacy, with a ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10631438/

Real-world clinical effectiveness of sorafenib among ... Most patients were reported to have Barcelona Clinic Liver Cancer stage B (19%) or stage C (70%) disease. Of 134 patients, 110 (82%) were reported to have ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-01365

Pressure Enabled Delivery of SD-101 With Checkpoint ... 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 ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.2521

Safety and early biologic effects of phase 1 PERIO-01 trial ... HAI of SD-101 has been well tolerated and associated with encouraging immunologic activity. Evidence of biologic effects at the lower doses of SD-101 with ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9365346/

Intralesional SD-101 in Combination with Pembrolizumab ... Combined positive score was ≥1 to < 20 in 35 patients (70%) and ≥ 20 in 15 patients (30%) of 50 patients with available data. There were 12 patients with grade ...

8. withpower.com withpower.com/trial/phase-2-hepatocellular-carcinoma-2-2022-de7e7

SD-101 + Checkpoint Inhibitors for Liver Cancer Trial Overview This study tests SD-101 delivered directly into the liver artery using pressure technology alone or combined with immune checkpoint blockers ( ...