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
Recruiting
Apply to this trial

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

Start date
Jan 3, 2025
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
20 participants (estimated)
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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoSan DiegoCalifornia92093
Adam Burgoyne, MD, PhD
[email protected]
858-822-5354

Find similar trials in San Diego, CA

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

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