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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
Study Summary
This trial is testing a new treatment for advanced pancreatic cancer using injections and drugs to boost the immune system.
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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreTrial 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
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously been treated with SD-101.My liver disease is moderately to severely advanced.My cancer has spread to distant parts of my body.I cannot stop my long-term blood thinner medication.I have severe portal hypertension shown by GI bleeding or low platelets with an enlarged spleen.I have an active hepatitis B or C infection.I had a severe reaction to previous immunotherapy.I have an active autoimmune disease or a history of IgG4-related pancreatitis.I am taking more than 10 mg of prednisone daily or any immunosuppressive medication.I have no other cancers, or if I do, they're not currently being treated and are stable.I have chronic pancreatitis.I haven't had chemotherapy, targeted therapy in the last 14 days, or radiation in the last 4 weeks.I have brain metastasis that hasn't been treated.I do not have COVID-19, severe infections, or uncontrolled HIV.I have a history of bleeding disorders.I had bacterial pneumonia within the last 8 weeks.I have an autoimmune or immune-mediated disease.I am over 18 and have advanced pancreatic cancer that cannot be surgically removed.I had treatment for my cancer but it didn't fully clear on scans.I haven't had chemotherapy or experimental drugs in the last 14 days.I am fully active or restricted in physically strenuous activity but can do light work.My previously inoperable cancer can now be surgically removed.I have a major blood clot in the liver's vein or severe swelling in my liver causing bleeding or fluid build-up not responding to treatment.Any side effects from my previous cancer treatments have mostly gone away.
Research Study Groups:
This trial has the following groups:- Group 1: SD-101
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the upper limit of patients engaged in this medical experiment?
"Confirmed. Evidence available on clinicaltrials.gov demonstrates that this experiment, which was first advertised on the 1st of November 2022, is still in its recruitment phase. The endeavour requires 60 participants from a single centre to be enrolled."
Answered by AI
Are new participants being sought for this trial at the present time?
"According to clinicaltrials.gov, this medical trial is open for recruitment with the first advertisement posted on November 1st 2022 and updated as recently as November 18th of the same year."
Answered by AI
Is SD-101 a reliable form of treatment for patients?
"Available evidence on SD-101's safety is somewhat scant, prompting our team at Power to assign it a score of 1. This early phase trial provides limited data regarding its efficacy and security."
Answered by AI
What goals is this clinical experiment attempting to accomplish?
"The main purpose of the clinical trial, which will span 12 months, is to ascertain the maximum tolerated dose (MTD) for SD-101 administered via PRVI. Secondary objectives include assessing overall survival over a one year period and RECIST v1.1 ORR as measures of activity, coupled with determining preliminary efficacy in terms of RECIST for immune based therapeutics on clinical benefit ([CR] + [PR] + [SD])."
Answered by AI
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