NCT05607953

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: TriSalus Life Sciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Locally Advanced Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-03-01
• Primary completion: 2027-09-01
• Completion: 2027-10-01
• First posted: 2022-11-07
• Last updated: 2025-07-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study