Study on Nab-Paclitaxel and Gemcitabine with or without VCN-01 for Patients with Metastatic Pancreatic Cancer

Sponsor: Theriva Biologics SL

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05673811

Provider View

This clinical trial is testing a combination of chemotherapy drugs, Nab-Paclitaxel and Gemcitabine, with or without an additional treatment called VCN-01, to see if it can help treat patients with pancreatic cancer that has spread to other parts of the body.

Patient Parameters

Program Overview

This study is exploring whether adding a new treatment, VCN-01, to the standard chemotherapy drugs Nab-Paclitaxel and Gemcitabine can improve outcomes for patients with metastatic pancreatic cancer. VCN-01 is a modified virus designed to target and destroy cancer cells. The trial will involve about 92 patients from North America and the European Union, who will be randomly assigned to receive either the standard chemotherapy alone or with VCN-01. Researchers will monitor the safety and effectiveness of these treatments.

Description

This clinical trial involves two groups of patients with metastatic pancreatic cancer. One group will receive the standard chemotherapy treatment with Nab-Paclitaxel and Gemcitabine, while the other group will receive the same chemotherapy plus up to two doses of VCN-01, a new investigational treatment. The study aims to determine if adding VCN-01 can improve treatment outcomes. Patients will be monitored regularly to ensure safety and to evaluate the effectiveness of the treatments. The trial will take place at multiple centers in North America and the European Union, with a total of 92 participants. A committee will review the data at regular intervals to ensure the trial's safety and progress.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Be 18 years or older.
  • Have a confirmed diagnosis of stage IV pancreatic cancer that has not been treated with systemic therapy before.
  • Have at least one tumor that can be measured by scans.
  • Be willing to follow the study treatment plan.
  • Have a life expectancy of at least 5 months.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Use effective contraception if of childbearing potential.
  • Have adequate organ function as shown by specific blood tests, including:
    • Sufficient blood cell counts.
    • Normal liver and kidney function.
    • Adequate nutritional status.

Exclusion Criteria

  • Not willing to complete study procedures due to location, mental health, or social reasons.
  • Have an active infection or serious illness, including tuberculosis, hepatitis B or C, or HIV.
  • Have received certain vaccines recently.
  • Have chronic liver disease or significant liver scarring.
  • Have taken another investigational drug recently.
  • Have a viral illness within two weeks before starting the study.
  • Are on chronic immunosuppressive therapy.
  • Have another active cancer.
  • Live with someone who is immunosuppressed.
  • Have certain genetic conditions like Li Fraumeni syndrome.
  • Are pregnant or breastfeeding.
  • Are on full-dose blood thinners that cannot be stopped temporarily.
  • Have untreated or worsening brain metastases.
  • Have any condition that would make participation unsafe.
  • Have a history of lung disease or nerve damage.
  • Have risk factors for bowel perforation.
  • Have certain heart conditions or allergies to study drugs.
  • Have other recommended first-line treatment options.

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