Study on EDV Nanocell Therapy with Gemcitabine and Nab-paclitaxel for Pancreatic Cancer

Sponsor: Engeneic Pty Limited

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07049055

Provider View

This clinical trial is testing a new treatment that combines EDV nanocell therapy with standard chemotherapy drugs gemcitabine and nab-paclitaxel to see if it is safe and can help improve survival in patients with advanced pancreatic cancer.

Patient Parameters

Program Overview

The purpose of this study is to find out if a new treatment using EDV nanocell therapy, combined with the chemotherapy drugs gemcitabine and nab-paclitaxel, is safe and can help patients with advanced pancreatic cancer live longer. The study compares this new combination treatment to the standard chemotherapy treatment alone in patients whose cancer has worsened after previous treatments.

Description

This study is exploring a new treatment for patients with advanced pancreatic cancer that has spread and worsened after initial treatments. The experimental treatment involves a special type of chemotherapy drug, PNU-159682, delivered directly to the cancer cells using a technology called EDV nanocell. This technology targets cancer cells that have a specific marker called EGFR, helping to kill the cancer cells more effectively.

The treatment also includes another investigational product that boosts the immune system to fight cancer. This combination is called E-EDV-D682/GC. The study is divided into two parts:

  • Cohort 1: An initial phase to test the safety of the new treatment in a small group of patients. If the treatment is safe, the study will move to the next phase.
  • Cohort 2: A larger phase where patients are randomly assigned to receive either the new treatment (E-EDV-D682/GC with gemcitabine and nab-paclitaxel) or the standard treatment (gemcitabine and nab-paclitaxel with a placebo).

Patients will receive treatment in cycles, with regular visits to the clinic for monitoring and evaluation. The study aims to determine if the new treatment can improve outcomes for patients with this type of cancer.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of advanced pancreatic cancer that has spread.
  • Aged 18 or older.
  • Good overall health with a performance status score of 0 or 1.
  • Expected to live at least 3 more months.
  • Cancer that can be measured by scans.
  • Tumors must have the EGFR marker.
  • Cancer must have worsened after initial treatment with specific chemotherapy regimens.
  • Only one previous line of treatment for advanced cancer is allowed.
  • Adequate levels of albumin, blood cell counts, kidney, liver, and heart function.
  • Women must not be pregnant and must use effective birth control during and after the study.
  • Men must use effective birth control during and after the study.
  • Willingness to follow study procedures and provide informed consent.

Exclusion Criteria

  • Currently receiving another experimental treatment.
  • Unresolved side effects from previous cancer treatments.
  • Significant fluid buildup around the heart, lungs, or abdomen.
  • History of cancer spread to the brain or spinal cord.
  • Ongoing treatment for other cancers, except hormone therapy.
  • History of other cancers within the last two years, unless low risk.
  • Uncontrolled diabetes or heart disease.
  • Uncontrolled high blood pressure or heart rhythm problems.
  • Certain heart conditions or infections like HIV, hepatitis B or C.
  • Active or severe infections.
  • High calcium levels in the blood.
  • Recent major surgery or radiation therapy.
  • Allergies to study drugs or components.
  • Pregnant or breastfeeding women.
  • Inability to comply with study visits or procedures.
  • Any other condition that may pose a risk to the patient or affect study results.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.