What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, particularly those involving immunotherapy and checkpoint inhibitors like TLR 9 agonists, can cause a range of side effects. These may include immune-related adverse events such as skin reactions, endocrine disorders, and gastrointestinal issues like diarrhea. Other potential side effects include fatigue, infusion-related reactions, and, in severe cases, pneumonitis or hepatitis. Close monitoring and supportive care are essential to manage these side effects effectively.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for TLR 9 agonists like SD-101 in the treatment of pancreatic cancer. However, it does reference other treatments such as gemcitabine, S-1, and FOLFIRINOX, which have been studied and used in various regimens for potentially resectable pancreatic cancer. These treatments focus on chemotherapy combinations to improve survival rates in patients with pancreatic cancer.

What other types of research exist?

Promising novel alternatives to SD-101 for pancreatic cancer patients include: <ol> <li>Immune checkpoint inhibitors such as pembrolizumab, especially in combination with other treatments.</li> <li></li> </ol> Toll-like receptor 2 (TLR2) and Toll-like receptor 4 (TLR4) modulators, which have shown favorable prognostic potential. 3. Personalized, genotype-directed therapies targeting specific genetic mutations in pancreatic cancer. 4. Combination therapies involving PD-1/PD-L1 inhibitors and other agents like chemotherapy or other immunotherapies.

← Back to Search

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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Do I qualify?Apply below to find out

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.