Pressure Enabled Intrapancreatic Delivery of SD-101 With Checkpoint Blockade for Locally Advanced Pancreatic Adenocarcinoma
NCT05607953 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-07-04
Summary
This study is an open-label, phase 1/1b study of the pressure-enabled intrapancreatic infusion of SD-101, a TLR 9 agonist, alone or in combination with intravenous checkpoint blockade in adults with locally advanced pancreatic cancer.
Conditions
- Locally Advanced Pancreatic Adenocarcinoma
Interventions
- DRUG
-
SD-101
SD-101 doses are administered via PRVI using the PEDD method of administration
- BIOLOGICAL
-
anti-PD-1
In the Phase 1b, anti-PD-1 will be administered together with SD-101
Sponsors & Collaborators
-
TriSalus Life Sciences, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-01
- Primary Completion
- 2027-09-30
- Completion
- 2027-10-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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