What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as chemotherapy and targeted therapies, often cause side effects like nausea, vomiting, fatigue, and increased infection risk. Targeted therapies may also lead to skin rash, diarrhea, and liver toxicity. Investigational treatments like mesenchymal stromal cells-derived exosomes with KrasG12D siRNA could potentially cause immune reactions, off-target effects, and delivery-related issues, though detailed side effect profiles are still under study.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, primarily focusing on chemotherapy and targeted therapies. Notably, treatments like gemcitabine and nab-paclitaxel are commonly used. More recently, the FDA approved olaparib, a PARP inhibitor, for patients with germline BRCA-mutated metastatic pancreatic cancer. While these treatments do not directly align with the investigational iExosomes therapy involving mesenchymal stromal cells-derived exosomes with KrasG12D siRNA, they represent the broader landscape of targeted and molecular therapies in pancreatic cancer treatment.

What other types of research exist?

Promising novel alternatives to iExosomes for pancreatic cancer patients include multitargeted kinase inhibitors like regorafenib, cabozantinib, sorafenib, and lenvatinib, which have shown some activity in various cancers. Additionally, immunotherapy agents such as atezolizumab and durvalumab, which have demonstrated improved survival outcomes in other cancers, may also be considered. Further clinical trials and data are needed to confirm their efficacy specifically for pancreatic cancer.

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Virus Therapy

iExosomes for Pancreatic Cancer

Phase 1

Waitlist Available

Led By Shubham Pant

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have documented progression or stable disease on one or more lines of systemic therapy. If stable disease, patient must have completed at least 4 months of chemotherapy with cytotoxic therapy

ECOG (Eastern Cooperative Oncology Group) performance status of 0-1

Must not have

Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, uncontrolled diabetes, serious active or uncontrolled infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests tiny particles from special cells carrying genetic material to treat pancreatic cancer patients with a specific mutation. The particles deliver this material into cancer cells to stop them from growing by silencing a harmful gene. Gene therapy is being explored as a novel treatment for pancreatic cancer, targeting specific genetic alterations to inhibit cancer progression.

Who is the study for?

This trial is for adults with metastatic pancreatic cancer that has a specific mutation (KrasG12D). Participants must have tried at least one systemic therapy and have certain blood and organ function levels within normal ranges. Pregnant or breastfeeding individuals are excluded, as well as those with severe medical conditions or brain metastases unless treated and stable.

What is being tested?

The trial is testing the safety and optimal dosage of iExosomes—tiny vesicles from mesenchymal stromal cells carrying siRNA targeting the KrasG12D mutation. The goal is to see if they can effectively treat pancreatic cancer that has spread in the body.

What are the potential side effects?

As this is a phase I trial primarily focused on determining the best dose, side effects are being studied; however, potential risks may include typical reactions to biological therapies such as immune responses, inflammation, or injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has either not changed or worsened after treatment.

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I am fully active or can carry out light work.

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My pancreatic cancer has a specific KrasG12D mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe health issues that could affect my participation in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose Determined by Dose Limiting Toxicity

Minimal residual disease rate in high-risk patients

Overall survival (OS)

+1 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: Treatment (iExosomes)Experimental Treatment1 Intervention

Participants receive mesenchymal stromal cells-derived exosomes with KrasG12D siRNA IV over 15-20 minutes on days 1, 4, and 10. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Participants who respond may continue 3 additional courses.

0 / 4Eligibility criteria met

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, which targets rapidly dividing cancer cells but also affects the tumor microenvironment (TME) by remodeling stromal components. This remodeling can influence the efficacy of the treatment. The iExosomes trial focuses on mesenchymal stromal cells-derived exosomes loaded with KrasG12D siRNA, which specifically targets the KRAS mutation common in pancreatic cancer. This approach aims to inhibit the KRAS-driven tumorigenesis directly, potentially offering a more precise and effective treatment. Understanding these mechanisms is crucial for patients as it highlights the importance of targeting both cancer cells and the supportive TME, potentially leading to more effective and personalized therapies.

Therapeutic Status and Available Strategies in Pancreatic Ductal Adenocarcinoma.Chemotherapy and tumor microenvironment of pancreatic cancer.