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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
TriSalus Life Sciences, Inc.
Study ID
NCT05220722
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • SD-101 — DRUG
    SD-101 doses will be delivered via HAI using the PEDD method of administration.
  • Pembrolizumab — BIOLOGICAL
    During Phase 1b, Cohort B, pembrolizumab will be administered together with SD-101.
  • Nivolumab — BIOLOGICAL
    During Phase 1b, Cohort C, nivolumab will be administered together with ipilimumab and SD-101.
  • Ipilimumab — BIOLOGICAL
    During Phase 1b, Cohort C, ipilimumab will be administered together with nivolumab and SD-101.

Study Details

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).

Key Dates

Start date
Mar 2, 2022
Status verified
Oct 2025
Primary completion
Jul 31, 2024
Completion
Jul 31, 2024

Study Design

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

Arms

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

Primary Outcome Measure

Phase 1b: To Determine the Safety of SD-101 Alone, in Combination with Pembrolizumab, and in Combination with Nivolumab and Ipilimumab [ Time Frame: 12 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of ColoradoAuroraColorado80045-
Columbia UniversityNew YorkNew York10032-
Rhode Island HospitalProvidenceRhode Island02903-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Aurora, CO

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
University of Colorado· Aurora, COColumbia University· New York, NYRhode Island Hospital· Providence, RIMD Anderson Cancer Center· Houston, TX

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