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Pressure Enabled Intrapancreatic Delivery of SD-101 With Checkpoint Blockade for Locally Advanced Pancreatic Adenocarcinoma

Locally Advanced Pancreatic Adenocarcinoma Clinical Trial

Official title:
A Phase 1/1b Pressure Enabled Regional Immuno-Oncology Study of Pancreatic Retrograde Venous Infusion of SD-101 Alone and With Checkpoint Blockade for Locally Advanced Pancreatic Ductal Adenocarcinoma

Clinical Trial 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.

Clinical Trial Description

This study will be conducted in 2 phases. In Phase 1, escalating doses of SD-101 will be administered alone via PRVI into the regional vessels of the pancreas containing the locally advanced tumor. The first three patients will part of a safety run-in. Following determination of the recommended MTD or optimal biologic dose (OBD) of SD-101 for PRVI, the study will progress to Phase 1b to assess the safety of concomitant SD-101 and CPI usage, along with preliminary efficacy. Patients in Phase 1b will receive the SD-101 dose selected from Phase 1 together with systemic anti-PD-1, defined as any FDA approved anti-PD-1, checkpoint blockade. SD-101 will be administered over 2 cycles, with 1 dose per cycle and each cycle being about 6 weeks apart. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05607953
Study type Interventional
Source TriSalus Life Sciences, Inc.
Contact Ann-Marie Hulstine
Phone 484-252-1960
Email annmarie.hulstine@trisaluslifesci.com
Status Recruiting
Phase Phase 1
Start date March 1, 2023
Completion date October 2026
View Details
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