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Genetically Modified Human Adenovirus Encoding Human Ph20 Hyaluronidase

This article explores the ongoing clinical trial of VCN-01, a genetically modified human adenovirus encoding human PH20 hyaluronidase, in combination with standard therapy for patients with advanced pancreatic cancer. The study aims to assess the drug’s impact on overall survival and its safety profile when used alongside nab-paclitaxel and gemcitabine in treating metastatic pancreatic cancer.

Table of Contents

What is VCN-01?

VCN-01 is an innovative drug being studied for the treatment of metastatic pancreatic cancer. It is classified as a genetically modified human adenovirus encoding human PH20 hyaluronidase. This means that VCN-01 is a virus that has been altered in a laboratory to carry a specific gene that produces an enzyme called hyaluronidase[1].

How does VCN-01 work?

VCN-01 is designed to target cancer cells specifically. The virus is modified to replicate inside cancer cells, causing them to burst and die. Additionally, the hyaluronidase enzyme it produces helps break down a substance called hyaluronan, which is often found in high levels around pancreatic tumors. By breaking down this substance, VCN-01 may help other cancer treatments reach the tumor more effectively[1].

Clinical Trial Overview

A clinical trial called VIRAGE is currently underway to evaluate the effectiveness of VCN-01 in combination with standard chemotherapy drugs for metastatic pancreatic cancer. The main goals of this study are:

  1. To see if adding VCN-01 to standard treatment improves overall survival
  2. To assess the safety and tolerability of VCN-01
  3. To measure how well the treatment controls the cancer’s growth and spread

The study will compare two groups of patients: one receiving standard chemotherapy alone, and another receiving standard chemotherapy plus VCN-01[1].

Who can participate in the trial?

The trial is looking for adults (18 years or older) with confirmed metastatic pancreatic cancer who have not yet received treatment for their advanced disease. Some key eligibility criteria include:

  • Having at least one measurable tumor
  • Being in relatively good overall health (ECOG performance status of 0 or 1)
  • Having adequate organ function
  • Not having certain other medical conditions that could interfere with the study

It’s important to note that there are specific medical criteria that patients must meet to be eligible for the trial. A healthcare provider can help determine if a patient qualifies[1].

Treatment Details

In this study, VCN-01 is given as an intravenous infusion (through a vein) at two specific times:

  • Week 1 of the study
  • Week 14 of the study

This is in addition to the standard chemotherapy drugs, nab-paclitaxel and gemcitabine, which are given according to their usual schedule[1].

Potential Benefits

While the effectiveness of VCN-01 is still being studied, researchers hope it may offer several benefits:

  • Improved overall survival for patients with metastatic pancreatic cancer
  • Better control of tumor growth and spread
  • Potentially higher response rates to treatment
  • Longer-lasting responses to treatment

The study will also track changes in a tumor marker called CA 19-9, which may help indicate how well the treatment is working[1].

Safety Considerations

As with any experimental treatment, there may be risks and side effects associated with VCN-01. The study is designed to carefully monitor patients for any adverse effects. Some specific safety considerations include:

  • Patients should not receive live vaccines for a period before and after treatment
  • Those in close contact with immunosuppressed individuals may not be eligible
  • Patients with certain pre-existing conditions (like pneumonitis or sensory neuropathy) may be excluded

The study team will provide detailed information about potential risks and closely monitor participants throughout the trial[1].

Aspect Details
Study Type Phase IIb, Open-label, Randomized Study
Condition Metastatic Pancreatic Cancer
Intervention VCN-01 with Nab-Paclitaxel and Gemcitabine
Primary Endpoints Overall Survival, Safety and Tolerability
Key Secondary Endpoints Progression-Free Survival, Overall Response Rate, Disease Control Rate
Dosing Schedule VCN-01 administered at Week 1 and Week 14
Eligibility Adults with first-line metastatic pancreatic adenocarcinoma stage IV de novo
Key Exclusion Criteria Pregnancy, untreated brain metastases, pre-existing sensory neuropathy, risk of bowel perforation

FAQ

  • What is VCN-01 and how does it work? VCN-01 is a genetically modified human adenovirus that encodes human PH20 hyaluronidase. It is designed to potentially enhance the effectiveness of standard chemotherapy treatments for metastatic pancreatic cancer by breaking down barriers in the tumor microenvironment.
  • Who is eligible for this clinical trial? Eligible participants are adults (18 years or older) with histologically or cytologically confirmed, first-line metastatic pancreatic adenocarcinoma stage IV de novo, who have not received previous systemic treatment for their pancreatic cancer. They must have at least one measurable tumor lesion and meet specific health criteria.
  • What is the main objective of this clinical trial? The main objective is to evaluate the time from randomization until death (overall survival) in both treatment arms and to assess the safety and tolerability of VCN-01 when administered intravenously at Week 1 and Week 14 in one of the treatment arms.
  • How is VCN-01 administered in this trial? VCN-01 is administered intravenously (through a vein) at Week 1 and Week 14 in one of the treatment arms, alongside the standard therapy of nab-paclitaxel and gemcitabine.
  • What are some of the key exclusion criteria for this trial? Key exclusion criteria include pregnancy or lactation, untreated brain metastases with progressive symptoms, pre-existing sensory neuropathy >G1, risk factors for bowel perforation, and certain active infections or autoimmune diseases. Patients with Li Fraumeni syndrome or known retinoblastoma protein pathway germline deficiency are also excluded.

Ongoing Clinical Trials on Genetically Modified Human Adenovirus Encoding Human Ph20 Hyaluronidase

  • Study on the Effects of VCN-01 with Nab-Paclitaxel and Gemcitabine for Patients with Advanced Pancreatic Cancer

    Not recruiting

    1 1
    Investigated drugs:
    Spain

Glossary

  • Metastatic Pancreatic Cancer: A type of cancer that starts in the pancreas and has spread to other parts of the body.
  • VCN-01: A genetically modified human adenovirus encoding human PH20 hyaluronidase, designed to potentially enhance the effectiveness of chemotherapy in treating pancreatic cancer.
  • Nab-paclitaxel: A chemotherapy drug used in combination with gemcitabine as standard therapy for metastatic pancreatic cancer.
  • Gemcitabine: A chemotherapy drug commonly used in combination with nab-paclitaxel to treat metastatic pancreatic cancer.
  • Overall Survival (OS): The length of time from the start of treatment until death from any cause.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives without the cancer progressing or getting worse.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors, version 1.1 – a set of rules used to measure how well a cancer patient responds to treatment.
  • ECOG Performance Status: A scale used to assess how a patient's disease is progressing and how it affects daily living abilities.
  • Ca 19.9: A tumor marker often used to monitor pancreatic cancer progression and treatment response.
  • Intravenous (IV): A method of administering medication directly into a vein.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-vcn-01-with-nab-paclitaxel-and-gemcitabine-for-patients-with-advanced-pancreatic-cancer/