🏛️ Verified NIH Record • Updated 2025-07-01

Pressure Enabled Intrapancreatic Delivery of SD-101 With Checkpoint Blockade for Locally Advanced Pancreatic Adenocarcinoma (NCT05607953)

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

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: TriSalus Life Sciences, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (29 items) and avoid the listed exclusions (23 items).

Location: MD Anderson Cancer Center — Houston, Texas

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Main portal, superior mesenteric vein, or splenic vein thrombosis with complete occlusion
  • Severe portal hypertension, as evidenced by gastrointestinal (GI) bleeding, thrombocytopenia with splenomegaly
  • Chronic pancreatitis
  • Active autoimmune disease or history of IgG4 related pancreatitis
  • Conversion to local resectability following prior treatment
  • Has received chemotherapy or an investigational agent within 14 days (or 5 half-lives, whichever is shorter) before screening
  • Has active, untreated brain metastasis
  • Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • Has main portal vein thrombosis, or severe portal hypertension as defined by a history of variceal hemorrhage or active ascites accumulation refractory to medical management
  • Has Child-Pugh Class B or C cirrhosis.
  • Has experienced a Grade 3 or higher immune-related AE from prior CPI therapy

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • MD Anderson Cancer Center — Houston, Texas

📞 Contact the Study Coordinator

Phone: (877) 632-6789

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗