Study on iExosomes for Treating Metastatic Pancreatic Cancer with KrasG12D Mutation

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT03608631

Provider View

This clinical trial is testing a new treatment using iExosomes, which are tiny particles derived from special cells, to see if they can help treat pancreatic cancer that has spread and has a specific KrasG12D mutation. The study aims to find the best dose and understand any side effects.

Patient Parameters

Program Overview

The purpose of this Phase I study is to determine the safest and most effective dose of iExosomes, which are derived from mesenchymal stromal cells and contain a special RNA targeting the KrasG12D mutation. This mutation is found in some pancreatic cancers that have spread to other parts of the body. Researchers hope that iExosomes can better treat this type of cancer by targeting the mutation directly.

Description

The main goals of this study are to find the highest dose of iExosomes that patients can tolerate without severe side effects and to identify any dose-related toxicities. Researchers will also look at how the body processes iExosomes and how well they work in controlling the cancer.

Participants will receive iExosomes through an IV infusion over 15-20 minutes on specific days, with treatment cycles repeating every 14 days for up to 3 courses. If the cancer responds well, participants may receive up to 3 additional courses. After treatment, participants will have follow-up visits to monitor their health and the treatment's effects.

The study will also explore optional tissue and blood samples to detect the KrasG12D mutation and evaluate the presence of the treatment's RNA in the body.

Eligibility Criteria

Inclusion Criteria

  • Have metastatic pancreatic cancer with the KrasG12D mutation confirmed by lab tests.
  • Have shown disease progression or stable disease after at least one line of systemic therapy, with at least 4 months of chemotherapy if stable.
  • Have a performance status of 0-1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Meet specific blood count and organ function criteria, including:
    • Neutrophil count of at least 1,500 cells/mm3.
    • Platelet count of at least 100,000/ul.
    • Hemoglobin level above 9.0 g/dL.
    • Liver and kidney function within specified limits.
  • Women of childbearing potential must have a negative pregnancy test and use effective contraception during the study and for 12 weeks after the last dose.
  • Men must use effective contraception during the study and for 12 weeks after the last dose.
  • Must sign an informed consent form acknowledging the investigational nature of the study.

Exclusion Criteria

  • Have severe or uncontrolled medical conditions that could interfere with the study, such as recent heart attack, unstable heart rhythm, uncontrolled diabetes, or serious infections.
  • Are pregnant or breastfeeding.
  • Have untreated or unstable brain metastases, except for those that have been treated and are stable without ongoing steroid use. Patients with stable brain metastases may participate if they meet specific criteria.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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