SD-101 + Pembrolizumab for Pancreatic Cancer

Overseen By Ann-Marie Hulstine

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: TriSalus Life Sciences, Inc.

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Chronic pancreatitis, Autoimmune disease, Hepatitis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial requires that you have not received chemotherapy or targeted therapy within 14 days before screening. If you are on chronic anticoagulation therapy, you must be able to be temporarily removed from it. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What data supports the effectiveness of the drug Pembrolizumab for pancreatic cancer?

Pembrolizumab has shown clinical activity in a variety of solid tumors, including non-small-cell lung cancer and melanoma, and is approved for esophageal cancer, but it provides minimal benefit for most patients with pancreatic cancer. ^{1 2 3 4 5}

Is the combination of SD-101 and Pembrolizumab safe for humans?

Pembrolizumab, also known as Keytruda, has been used in various cancer treatments and is generally considered safe, but it can cause side effects like fatigue, nausea, and immune-related issues such as thyroid problems and type 1 diabetes in rare cases. These side effects have been observed in treatments for other cancers, not specifically pancreatic cancer. ^{1 2 3 4 6}

How is the drug SD-101 + Pembrolizumab unique for treating pancreatic cancer?

The combination of SD-101 and Pembrolizumab is unique because it involves using an immune checkpoint inhibitor (Pembrolizumab) that targets the PD-1 pathway, which is a novel approach for pancreatic cancer, a condition with limited effective treatments. Pembrolizumab has shown activity in other cancers, but its use in pancreatic cancer is still being explored, making this combination a new potential option. ^{1 2 3 4 5}

Eligibility Criteria

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.

Inclusion Criteria

Has a QTc interval ≤480 msec

Has a life expectancy of >3 months at screening as estimated by the Investigator

Able to understand the study and provide written informed consent prior to any study procedures

Exclusion Criteria

I have previously been treated with SD-101.

Patients who were enrolled in the Phase 1 portion of the study will not be eligible for enrollment in Phase 1b

My liver disease is moderately to severely advanced.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Escalating doses of SD-101 administered alone via PRVI into the regional vessels of the pancreas

12 months

Phase 1b Treatment

SD-101 administered with systemic anti-PD-1 checkpoint blockade over 2 cycles, each cycle being about 6 weeks apart

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Pembrolizumab (Checkpoint Inhibitor)
• SD-101 (TLR 9 Agonist)

Trial Overview 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.

Participant Groups

Group I: SD-101 Experimental Treatment 2 Interventions

Two doses of SD-101 given over two cycles via pancreatic retrograde venous infusion (PRVI) using the PEDD method of administration.

Who Is Running the Clinical Trial?

TriSalus Life Sciences, Inc.

Lead Sponsor

Trials

10

Recruited

420+

Findings from Research

Pembrolizumab, a PD-1 inhibitor used in cancer treatment, can lead to rare but serious immune-related adverse events, including type 1 diabetes mellitus, occurring in about 0.2% of cases.

A review of 42 cases revealed that patients may develop diabetic ketoacidosis during treatment, highlighting the need for blood glucose monitoring and awareness of this potential side effect among clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. Clotman, K., Janssens, K., Specenier, P., et al.[2022]

In a study of 41 pancreas cancer patients treated with pembrolizumab, the median overall survival was 7.2 months, which is considered favorable compared to the benchmark of over 4 months.

Patients with specific genetic markers (dMMR, MSI-H, TMB-H, or Lynch syndrome) had a significantly lower risk of death, indicating that these biomarkers may help identify patients who could benefit more from pembrolizumab treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab near the end of life in patients with metastatic pancreatic cancer: a multi-site consecutive series to examine survival and patient treatment burden. Storandt, MH., Tran, N., Martin, N., et al.[2023]

In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.

The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]

Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.

Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. Karim, S., Leighl, N.[2017]

Pembrolizumab (Keytruda) is an approved treatment for metastatic or locally advanced esophageal and gastroesophageal junction cancer, indicating its efficacy in targeting these specific cancer types.

It is used in combination with platinum- and fluoropyrimidine-based chemotherapy, suggesting a synergistic approach to enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab Approved for Esophageal or Gastroesophageal Cancer. Aschenbrenner, DS.[2023]

Pembrolizumab (KEYTRUDA) was approved by the FDA for treating advanced melanoma, showing an overall response rate of 24% in a trial of 89 patients, with 86% of responses lasting at least 6 months.

While there are potential immune-mediated side effects, the benefits of prolonged tumor response durations were deemed to outweigh these risks, marking an improvement over existing treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. Chuk, MK., Chang, JT., Theoret, MR., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Pembrolizumab near the end of life in patients with metastatic pancreatic cancer: a multi-site consecutive series to examine survival and patient treatment burden. [2023]

3. Ireland pubmed.ncbi.nlm.nih.gov

Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Pembrolizumab Approved for Esophageal or Gastroesophageal Cancer. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]