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Checkpoint Inhibitor

SD-101 + Checkpoint Inhibitors for Liver Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by TriSalus Life Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Nonsterilized males must agree to contraception measures
Must have previously received 1 line of standard therapy for liver cancer and have persistent or progressive measurable disease not amenable to curative therapies
Must not have
Previously received SD-101
Has active, untreated brain metastasis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved

Summary

This trial is testing a new cancer treatment that uses a TLR9 agonist to treat HCC and ICC.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include reactions at the infusion site, flu-like symptoms from SD-101; fatigue, skin issues, hormonal changes from Nivolumab and Pembrolizumab; and potentially more serious immune-related effects from Ipilimumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man who can father children and agree to use birth control.
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I have liver cancer, have tried one standard treatment, and my cancer is still growing or present.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 or older with advanced liver cancer or bile duct cancer.
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My liver function is classified between Child-Pugh A to B7.
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I haven't had chemotherapy, targeted therapy, or radiation in the last 14 days.
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I have never had embolic HAI therapy with permanent materials.
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My liver cancer can be measured by standard health guidelines.
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My liver cancer is confirmed by tests and mainly affects my liver.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have previously been treated with SD-101.
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I have brain metastasis that hasn't been treated.
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I had a severe reaction to previous immunotherapy.
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I do not have active COVID-19, severe infections, or uncontrolled HIV.
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I haven't had chemotherapy or experimental drugs in the last 14 days.
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I have a history of bleeding disorders.
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I have a major blood clot in the liver's vein or severe high blood pressure in the liver.
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Most of my liver is affected by cancer.
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I cannot stop my regular blood thinner medication.
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My liver disease is severe, classified as Child-Pugh B 8-9 or C.
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I am taking more than 10 mg of prednisone or its equivalent daily.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1b: To Determine the Maximum Tolerable Dose (MTD) or Optimal Dose of SD-101 alone, in Combination with Pembrolizumab, and in Combination with Nivolumab and Ipilimumab
Phase 1b: To Determine the Safety of SD-101 Alone, in Combination with Pembrolizumab, and in Combination with Nivolumab and Ipilimumab
Phase 2: To Assess Overall Response Rate (ORR)
Secondary study objectives
Phase 1b: Assess Preliminary Efficacy in Terms of RECIST v1.1 for Immune Based Therapeutics
Phase 1b: Assess Preliminary Efficacy in Terms of iRECIST for Immune Based Therapeutics
Phase 1b: Assess Preliminary Efficacy in Terms of modified RECIST (mRECIST) for Immune Based Therapeutics
+3 more

Side effects data

From 2017 Phase 1 & 2 trial • 9 Patients • NCT02254772
100%
Myalgia
100%
Arthralgia
100%
Headache
100%
Fatigue
56%
Fever
56%
Injection site reaction
44%
Chills
33%
Nasal Congestion
33%
Bruising
33%
Cough
33%
Rash
33%
Swelling
22%
Induration
22%
Bloating
11%
Neutropenia
11%
Anemia
11%
Back pain
11%
Diarrhea
11%
Dysphagia
11%
Anorexia
11%
Nausea
11%
Flu Like Symptoms
11%
Pancytopenia
11%
Sepsis
11%
Malaise
11%
Increased Creatinine
11%
Dyspnea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (SD-101 + Ipilimumab + Radiation)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SD-101Experimental Treatment4 Interventions
Three weekly doses of SD-101 given over two cycles via HAI using the PEDD method of administration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SD-101
2014
Completed Phase 2
~90
Nivolumab
FDA approved
Ipilimumab
FDA approved
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

TriSalus Life Sciences, Inc.Lead Sponsor
4 Previous Clinical Trials
183 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05220722 — Phase 1 & 2
Liver Cancer Research Study Groups: SD-101
Liver Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT05220722 — Phase 1 & 2
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05220722 — Phase 1 & 2
~24 spots leftby Dec 2025
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