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Hepatocellular CarcinomaPhase 1/2NCT05220722

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

A Phase 1/2 study testing SD-101, Pembrolizumab and Nivolumab in people with Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma, run by TriSalus Life Sciences, Inc. at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
SD-101, Pembrolizumab and Nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
4 sitesUnited States
Study dates
2 Mar 2022to 31 Jul 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older with locally advanced, metastatic or unresectable hepatocellular carcinoma or intrahepatic cholangiocarcinoma, with the diagnosis confirmed by radiologic, histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases.
  • Previously received 1 line of standard therapy for liver cancer and with persistent or progressive measurable disease, as defined by RECIST version 1.1, that is not amenable to curative therapies
  • Performance status score of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale (scores range from 0 to 5, with higher numbers reflecting greater disability)
  • Designation of class A to B7 on the Child-Pugh liver function scale (a three-category scale [A, B, or C], with C indicating the most severe compromise of liver function)
  • Adequate hematologic and organ function.
  • Has radiographically, histologically or cytologically confirmed HCC or ICC with liver-only or liver-dominant disease. Liver-dominant will be defined as intrahepatic disease representing the largest fraction of disease.
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  • Able to understand the study and provide written informed consent prior to any study procedures
  • Has not received prior cytotoxic chemotherapy, targeted therapy, or external radiation therapy within 14 days prior to C1D1
  • Has not ever received prior embolic HAI therapy with permanent embolic material.
  • Note: Previous embolic HAI therapy with permanent embolic material will not be exclusionary if following this therapy, the target vessels are not occluded, and tumors are perfused based on the patient's screening imaging.
  • Prior surgical resection or radiofrequency ablation of oligometastatic liver disease is allowed. Liver lesions that received ablative therapies should not be considered target lesions unless they have clearly progressed since the therapy or have viable tumor on contrast enhanced MRI or CT.
  • Has no prior history of or other concurrent malignancy unless the malignancy is clinically insignificant, no ongoing treatment is required, and the patient is clinically stable
  • Has measurable disease in the liver according to RECIST v.1.1 criteria
  • Has a life expectancy of >3 months at screening as estimated by the investigator
  • Has a QTc interval ≤480 msec
  • All associated clinically significant (in the judgment of the investigator) drug-related toxicity from previous cancer therapy must be resolved (to Grade ≤1 or the patient's pretreatment level) prior to study treatment administration (Grade 2 alopecia and endocrinopathies controlled on replacement therapy are allowed).
  • Has adequate organ function at screening as evidenced by:
  • Platelet count >80,000/μL
  • Hemoglobin ≥8.0 g/dL
  • White blood cell count (WBC) >2,000/μL
  • Serum creatinine ≤2.0 mg/dL unless the measured creatinine clearance is ≥30 mL/min calculated by Cockcroft-Gault formula.
  • Total and direct bilirubin ≤2.0 × the upper limit of normal (ULN) and alkaline phosphatase ≤5 × ULN. For patients with documented Gilbert's disease, total bilirubin up to 3.0 mg/dL is allowed.
  • ALT and AST ≤5 × ULN
  • Prothrombin time/International Normalized Ratio (INR) or activated partial thromboplastin time (aPTT) test results at screening ≤1.5 × ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose for at least 4 weeks prior to the first dose of study intervention) Note: Laboratory tests with exclusionary results judged by the investigator as not compatible with the patient's clinical status may be repeated once for eligibility purposes.
  • Females of childbearing potential must be nonpregnant and nonlactating, or post-menopausal, and have a negative serum human chorionic gonadotropin (hCG) pregnancy test result at screening and a negative urine or serum pregnancy test prior to the first dose of study intervention.
  • Females of childbearing potential must agree to abstain from sexual activity with nonsterilized male partners, or if sexually active with a nonsterilized male partner must agree to use highly effective methods of contraception from screening, throughout the study and agree to continue using such precautions for 100 days after the final dose of study intervention.
  • Nonsterilized males who are sexually active with a female of childbearing potential must agree to use effective methods of contraception and avoid sperm donation from Day 1 throughout the study and for 30 days after the final dose of study intervention.
  • For patients with a documented FGFR2 mutation, prior treatment with a FGFR2-targeted agent or refusal of treatment with at least one of these agents must be documented. For patients with a documented IHD1 mutation, prior treatment with an IHD1 targeted agent or refusal of treatment with ivosidenib must be documented.

Who cannot join

  • Has received chemotherapy or an investigational agent within 14 days (or 5 half-lives, whichever is shorter) before C1D1.
  • Has active, untreated brain metastasis.
  • Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • Has main portal vein thrombosis, or severe portal hypertension as defined by a history of variceal hemorrhage or active ascites accumulation refractory to medical management
  • Has more than 2/3 parenchymal replacement by tumor of both liver lobes.
  • Has Child-Pugh Class B 8-9 or C cirrhosis.
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  • Has experienced a Grade 3 or higher immune-related AE from prior CPI therapy.
  • Note: Patients who have experienced a Grade 3 immune-related AE from prior CPI therapy will not be excluded if that AE has since recovered to a Grade 1 for a minimum of 14 days.
  • Is unable to be temporarily removed from chronic anticoagulation therapy.
  • Has a history of bleeding disorders.
  • Has active coronavirus disease 2019 (COVID-19), other severe infection, including a liver infection, within 2 weeks before the first dose of study drug, or uncontrolled human immunodeficiency virus (HIV) infection at screening.
  • Has active, known, or suspected autoimmune disease or immune-mediated disease. Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger are not exclusionary.
  • Is receiving systemic steroid therapy >10 mg of prednisone daily or equivalent or any other immunosuppressive medication at any dose level. Local steroid therapies (e.g., otic, ophthalmic, intra-articular or inhaled medications) are acceptable.
  • Has significant concurrent or intercurrent illness, psychiatric disorder, or alcohol or chemical dependence that would, in the opinion of the Investigator and/or Medical Monitor, compromise their safety or compliance or interfere with interpretation of the study.
  • Lactating women are excluded from study participation.
  • Has previously received SD-101.
  • Medical history of significant hypersensitivity, severe and unresolved immune-mediated reactions, severe infusion-related reactions, or allergic reaction to TLR9 agonists or CPI agents in the judgment of the investigator.
  • Patients who were enrolled in the Phase 1b portion of the study will not be eligible for enrollment in Phase 2.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Colorado

    Aurora, Colorado, 80045

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Columbia University

    New York, New York, 10032

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

Other trials in United States

About this study

Official title: A Phase 1b/2 Pressure Enabled Regional Immuno-Oncology Study of Hepatic Arterial Infusion of SD-101 With Systemic Checkpoint Blockade for Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma

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).

Read the detailed description

All patients will receive 2 cycles of SD-101. Each cycle consists of 3 consecutive weekly infusions and Cycles 1 and 2 are separated by one month. Escalating doses of SD-101 will be administered alone (Cohort A), together with pembrolizumab (Cohort B), and together with combined ipilimumab and nivolumab (Cohort C). Cohort B will begin dosing at the minimum anticipated biological effect level (MABEL (2mg SD-101)). Cohort C will begin one dose level below the MTD or optimal dose from Cohort B to optimize safety when adding CPI to SD-101.

Following determination of the recommended MTD or optimal dose of SD-101 and which checkpoint inhibitor (CPI) regimen(s) are tolerated, the study will progress to Phase 2. Patients in Phase 2 will receive the SD-101 dose selected from Phase 1b together with systemic single- or double-agent checkpoint blockade. 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 in Phase 1b.

Being tested
SD-101, Pembrolizumab, Nivolumab, Ipilimumab
Keywords
Liver Tumors, SD-101, TLR9 Agonist, HCC, ICC
Medical subject headings
Carcinoma, Hepatocellular, Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SD-101Drug

    SD-101 doses will be delivered via HAI using the PEDD method of administration.

  • PembrolizumabBiological

    Also called Keytruda

    During Phase 1b, Cohort B, pembrolizumab will be administered together with SD-101.

  • NivolumabBiological

    Also called Opdivo

    During Phase 1b, Cohort C, nivolumab will be administered together with ipilimumab and SD-101.

  • IpilimumabBiological

    Also called Yervoy

    During Phase 1b, Cohort C, ipilimumab will be administered together with nivolumab and SD-101.

Study groups in NCT05220722
Study groupRoleWhat they receive
SD-101ExperimentalThree weekly doses of SD-101 given over two cycles via HAI using the PEDD method of administration.
Receives: Drug: SD-101; Biological: Pembrolizumab; Biological: Nivolumab; Biological: Ipilimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1b: To Determine the Safety of SD-101 Alone, in Combination with Pembrolizumab, and in Combination with Nivolumab and Ipilimumab

    As a measure of safety, adverse events will be graded according to CTCAE v5.0.

    Measured: 12 months

  2. 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

    A standard 3+3 dose-escalation design will be employed to determine the MTD or optimal dose.

    Measured: 12 months

  3. Phase 2: To Assess Overall Response Rate (ORR)

    As a measure of activity, ORR will be assessed. ORR will be assessed using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.

    Measured: 12 months

Secondary outcomes (8)

  1. Phase 1b: Assess Preliminary Efficacy in Terms of iRECIST for Immune Based Therapeutics

    As a measure of activity, iRECIST will be utilized to determine ORR.

    Measured: 12 months

  2. Phase 1b: Assess Preliminary Efficacy in Terms of modified RECIST (mRECIST) for Immune Based Therapeutics

    As a measure of activity, mRECIST will be utilized to determine ORR.

    Measured: 12 months

  3. Phase 1b: Assess Preliminary Efficacy in Terms of RECIST v1.1 for Immune Based Therapeutics

    As a measure of activity, RECIST 1.1 will be utilized to determine hepatic-specific response rate (HRR).

    Measured: 12 months

  4. Phase 1b: Assess Preliminary Efficacy in Terms of RECIST v1.1 for Immune Based Therapeutics

    As a measure of activity, RECIST 1.1 will be utilized to determine overall progression-free survival (PFS).

    Measured: 12 months

  5. Phase 1b: Assess Preliminary Efficacy in Terms of RECIST v1.1 for Immune Based Therapeutics

    As a measure of activity, RECIST 1.1 will be utilized to determine clinical benefit (complete response [CR] + partial response [PR] + stable disease [SD]).

    Measured: 12 months

  6. Phase 2: To Assess Treatment-Emergent Adverse Events of the Chosen MTD or Optimal Dose of SD-101 in Combination with CPI

    As a measure of safety, adverse events will be graded according to CTCAE v5.0.

    Measured: 6 months

  7. Phase 2: Assess Efficacy in Terms of RECIST v1.1 for Immune Based Therapeutics

    As a measure of activity, RECIST 1.1 will be utilized to determine duration of response (DOR).

    Measured: 12 months

  8. Phase 2: To Assess Overall Survival (OS)

    As a measure of activity, OS will be assessed. The events for the assessment of 12-month OS are death events.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2022
  2. Study start2 Mar 2022
  3. Primary completion31 Jul 2024
  4. Study completion31 Jul 2024

Why it stopped: The decision was made to terminate the study after the completion of Phase 1b enrollment and not proceed with Phase 2. Trial termination was not due to patient safety or data concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Phase 1b: Escalating doses of SD-101 will be administered alone (Cohort A), together with pembrolizumab (Cohort B), or together with combined ipilimumab and nivolumab. Three weekly doses of SD-101 are delivered over two cycles via HAI using the Pressure Enabled Drug Delivery (PEDD) method of administration. Phase 2: Three weekly infusions of SD-101 will be delivered via PEDD/HAI over two cycles at the dose selected from Phase 1b in combination with systemic single- or dual-agent checkpoint blockade.
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05220722
Sponsor's protocol ID
TS-PERIO-02
Status last verified
Oct 2025
First submitted
21 Jan 2022
Last updated
23 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SD-101, Pembrolizumab and Nivolumab in people with Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma, run by TriSalus Life Sciences, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The decision was made to terminate the study after the completion of Phase 1b enrollment and not proceed with Phase 2. Trial termination was not due to patient safety or data concerns.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1b: To Determine the Safety of SD-101 Alone, in Combination with Pembrolizumab, and in Combination with Nivolumab and Ipilimumab (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05220722.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.

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