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

NCT05220722 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: TS-PERIO-02
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

Hepatocellular Carcinoma; Intrahepatic Cholangiocarcinoma

Keywords

Liver Tumors; SD-101; TLR9 Agonist; HCC; ICC

Outcome Measures

Primary Outcomes (3)

• 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.

  12 months

• 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.

  12 months

• 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.

  12 months

Secondary Outcomes (8)

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

  12 months

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

  12 months

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

  12 months

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

  12 months

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

  12 months

Study Arms (1)

SD-101

EXPERIMENTAL

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

Drug: SD-101; Biological: Pembrolizumab; Biological: Nivolumab; Biological: Ipilimumab

Interventions

SD-101 DRUG

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

SD-101

Pembrolizumab BIOLOGICAL

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

Also known as: Keytruda

SD-101

Nivolumab BIOLOGICAL

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

Also known as: Opdivo

SD-101

Ipilimumab BIOLOGICAL

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

Also known as: Yervoy

SD-101

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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).

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• TriSalus Life Sciences, Inc.: lead

Study Sites (4)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Cholangiocarcinoma

Interventions

pembrolizumab; Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 2, 2022
• Study Start: March 2, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: October 23, 2025

Record last verified: 2025-10

Locations

US (4)