Cryoablation and Arterial Infusion of SD-101 in Combination With Durvalumab and Tremelimumab
NCT06710223 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-04-30
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
Interventions
- DRUG
-
SD-101
Toll-like receptor 9 (TLR9) agonist
- DEVICE
-
Cryotherapy
Cryoablation of liver
- DRUG
-
Tremelimumab
Anti-CTLA4
- DRUG
-
Anti-PDL1
Sponsors & Collaborators
-
TriSalus Life Sciences, Inc.
collaborator INDUSTRY -
Boston Scientific Corporation
collaborator INDUSTRY -
University of California, San Diego
lead OTHER
Principal Investigators
-
Adam Burgoyne, MD, PhD · University of California, San Diego
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-03
- Primary Completion
- 2027-06-30
- Completion
- 2027-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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