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

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT06710223
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SD-101 — DRUG
    Toll-like receptor 9 (TLR9) agonist
  • Cryotherapy — DEVICE
    Cryoablation of liver
  • Tremelimumab — DRUG
    Anti-CTLA4
  • Durvalumab — DRUG
    Anti-PDL1

Study Details

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).

Key Dates

First listed
Nov 29, 2024
Start date
Jan 3, 2025
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SD-101
    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).

Primary Outcome Measure

Adverse Events [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoSan DiegoCalifornia92093-

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Liver cancer
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OncologyGI oncologyHepatology
By research site
University of California, San Diego· San Diego, CA

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