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Checkpoint Inhibitor

SD-101 + Pembrolizumab for Pancreatic Cancer

Phase 1
Recruiting
Research Sponsored by TriSalus Life Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

This trial involves injecting a drug called SD-101 directly into the pancreas to treat adults with advanced pancreatic cancer. The drug helps boost the immune system to fight cancer and can be combined with another treatment to make it more effective.

Who is the study for?
Adults with advanced pancreatic cancer who haven't had recent chemotherapy, radiation, or other cancers. They must understand the study, consent to it, have a life expectancy over 3 months, stable organ function and blood counts within certain limits. Women of childbearing age must not be pregnant and agree to contraception.
What is being tested?
The trial is testing SD-101 delivered directly into the pancreas using pressure alongside pebrolizumab given intravenously. It's an early-phase study to see if this combination can help treat locally advanced pancreatic cancer that hasn't spread elsewhere.
What are the potential side effects?
Possible side effects include reactions at the infusion site, flu-like symptoms due to immune system activation by SD-101 (like fever or chills), and typical immune checkpoint inhibitor side effects such as fatigue, skin rash or potential autoimmune reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1 - To determine the maximum tolerated dose (MTD) or optimal biologic dose (OBD) of SD-101 administered alone via PRVI.
Phase 1b - To determine the safety of SD-101 administered via PRVI in combination with anti-PD-1 and to assess the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 disease control rate (DCR)
Secondary study objectives
Phase 1 - To assess the RECIST v1.1 ORR
Phase 1b - To assess preliminary efficacy in terms of RECIST 1.1 pancreatic-specific progression free survival (PPFS)
Pancreas
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: SD-101Experimental Treatment2 Interventions
Two doses of SD-101 given over two cycles via pancreatic retrograde venous infusion (PRVI) using the PEDD method of administration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SD-101
2014
Completed Phase 2
~90

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for pancreatic cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy, such as gemcitabine, works by interfering with the DNA replication of cancer cells, leading to cell death. Targeted therapies, like those inhibiting specific oncogenes or pathways (e.g., HER2), aim to block the growth and spread of cancer cells by targeting molecular abnormalities. Immunotherapy, including TLR agonists like SD-101, stimulates the immune system to recognize and attack cancer cells. These treatments are crucial for pancreatic cancer patients as they offer different mechanisms to combat the aggressive nature of the disease, potentially improving survival rates and quality of life.
Expression and significance of TLR4 and HIF-1alpha in pancreatic ductal adenocarcinoma.

Find a Location

Who is running the clinical trial?

TriSalus Life Sciences, Inc.Lead Sponsor
4 Previous Clinical Trials
212 Total Patients Enrolled

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05607953 — Phase 1
Pancreatic Cancer Research Study Groups: SD-101
Pancreatic Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05607953 — Phase 1
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05607953 — Phase 1
~23 spots leftby Oct 2025