Cryoablation and Arterial Infusion of SD-101 in Combination With Durvalumab and Tremelimumab

NCT06710223 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 810313
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this Phase 1b clinical trial is to evaluate the safety and efficacy of cryoablation and hepatic arterial administration of SD-101 in participants with advanced hepatocellular carcinoma. After this procedure, participants will be treated with tremelimumab and durvalumab every 4 weeks (STRIDE regimen).

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  The primary endpoint is the number and frequency of adverse events related to cryoablation and hepatic artery infusion of SD-101 in combination with durvalumab and tremelimumab. Adverse events (AEs) during the 6 months following Cryo+SD-101 will be recorded. The NCI CTCAE version 5.0 will be used to grade adverse events. Incidence of AEs will be summarized by event type, grade and body system. Particularly, the rates of infusion reactions, major bleeding, major infection, and grade 3 or above non-infection adverse events will be reported. The proportion of patients having each type of adverse event will be summarized along with a corresponding 90% confidence interval calculated using the exact method. The rate and 90% exact CI of subjects who experience serious adverse events will also be reported.

  6 months

Study Arms (1)

SD-101

EXPERIMENTAL

Participants will be treated with cryoablation and intrahepatic artery infusion of SD-101. This treatment will be followed by administration of the immune checkpoint inhibitors Tremelimumab and Durvalumab (STRIDE regimen). Tremelimumab 300mg will be given intravenously once, 7-10 days after cryoablation + SD-101. Durvalumab 1500mg will be given intravenously at the same time as Tremelimumab, and then every 28 days (on day 1 of every subsequent cycle).

Drug: SD-101; Device: Cryotherapy; Drug: Tremelimumab; Drug: Durvalumab

Interventions

SD-101 DRUG

Toll-like receptor 9 (TLR9) agonist

Also known as: nelitolimod

SD-101

Cryotherapy DEVICE

Cryoablation of liver

SD-101

Tremelimumab DRUG

Anti-CTLA4

SD-101

Durvalumab DRUG

Anti-PDL1

SD-101

Eligibility Criteria

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

You may qualify if:

• Willing and able to provide written informed consent prior to performance of any study- specific procedures.
• Age ≥ 18 years.
• Locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants:
• For cirrhotic participants with no histological confirmation of diagnosis, clinical confirmation is required per AASLD criteria.
• Pathological diagnoses of HCC will be made according to the International Working Party criteria.
• HCC with a component that measures at least 3 cm and that is located 1 cm or greater away from sensitive structures, including large blood vessels, large bile ducts, pericardium, diaphragm, gallbladder, stomach, and bowel.
• Is not a candidate for local therapies alone, including liver transplantation, tumor ablation, transarterial embolization, radiation therapy, or resection.
• No prior systemic therapy for advanced or metastatic HCC.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
• Evaluable target lesions as per Response Evaluation Criteria in Solid Tumors RECIST v1.1 or mRECIST.
• Child-Pugh A or Child-Pugh B7 liver function.
• Life expectancy of ≥ 12 weeks.
• Adequate bone marrow function defined as:
• Peripheral absolute neutrophil count ≥ 1000/mm\^3
• Platelet count ≥ 50,000/ mm\^3

You may not qualify if:

• Brain metastases or spinal cord compression, unless treatment was completed at least 4 weeks before study entry, and stable without steroid treatment for at least 4 weeks.
• Evidence of severe or uncontrolled systemic diseases \[e.g., unstable or uncompensated respiratory, cardiac (including life threatening arrhythmias)\].
• Unresolved toxicity ≥ CTCAE Grade 2 from previous anti-cancer therapy except alopecia (if applicable) unless agreed that the patient can be entered after discussion with the Medical Monitor.
• Presence of cardiac impairment defined as:
• prior history of cardiovascular disease including heart failure that meets New York Heart Association (NYHA) class III and IV definitions; OR
• history of myocardial infarction/active ischemic heart disease within one year of study entry; OR
• uncontrolled dysrhythmias; OR
• poorly controlled angina
• Participation in a trial of an investigational agent within the prior 30 days
• Pregnant or breast-feeding.
• High volume peritoneal or pleural effusions requiring centesis more frequently than every 14 days.
• Poorly controlled or refractory (grade 3-4) hepatic encephalopathy.
• History of allogeneic stem cell or solid organ transplantation.
• Prior history of pneumonitis/interstitial lung disease.
• Receipt of live vaccine within 30 days.

Sponsors & Collaborators

• Boston Scientific Corporation: collaborator
• University of California, San Diego: lead
• TriSalus Life Sciences, Inc.: collaborator

Study Sites (1)

University of California, San Diego

San Diego, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Cryotherapy; tremelimumab; durvalumab

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)

Therapeutics

Study Officials

• Adam Burgoyne, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Burgoyne, MD, PhD

CONTACT

858-822-5354; CancerCTO@health.ucsd.edu

Gastrointestinal Research Team

CONTACT

858-822-5354; CancerCTO@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor of Medicine

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: January 3, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)