#1 Clinical Trials Search in Europe

Gad20-209-Fsp-A2

A groundbreaking clinical trial is underway to evaluate the effectiveness of Gad20-209-Fsp-A2, a component of an innovative genetic vaccine called Nous-209. This study focuses on patients with advanced microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. The trial aims to assess the vaccine’s potential when combined with pembrolizumab, an immunotherapy drug, in treating this specific type of cancer.

Table of Contents

What is GAD20-209-FSP-A2?

GAD20-209-FSP-A2 is part of an innovative genetic vaccine called Nous-209, which is being developed to treat certain types of advanced colorectal cancer[1]. This vaccine is considered an advanced therapy, specifically a gene therapy product. It’s important to note that GAD20-209-FSP-A2 is one of four components that make up the complete Nous-209 vaccine[1].

How Does It Work?

The Nous-209 vaccine, including GAD20-209-FSP-A2, works in a unique way:

  • It’s based on a virus called adenovirus, specifically one found in great apes[1].
  • This virus has been modified to carry genetic information for special proteins called Frame Shift Proteins (FSPs)[1].
  • When injected into the body, it’s designed to stimulate the immune system to recognize and fight cancer cells[1].

The vaccine is given through an intramuscular injection, which means it’s injected directly into a muscle[1].

Who Is This Treatment For?

Nous-209, including GAD20-209-FSP-A2, is being developed for patients with:

  • Locally advanced unresectable or metastatic colorectal cancer. This means cancer that has spread locally or to other parts of the body and can’t be removed surgically[1].
  • Cancers that are microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). These are specific genetic features of some colorectal cancers[1].

Current Clinical Trial

GAD20-209-FSP-A2 is currently being studied in a clinical trial. Here are some key points about the trial:

  • It’s a Phase I/II trial, which means it’s testing both safety and how well the treatment works[1].
  • The trial is testing Nous-209 in combination with another drug called pembrolizumab[1].
  • The main goal is to see if the combination can shrink tumors or stop them from growing[1].
  • The trial is also looking at how safe the treatment is and how long its effects last[1].

Potential Benefits

While it’s important to remember that GAD20-209-FSP-A2 is still being studied, researchers hope it might:

  • Help shrink tumors or stop them from growing in patients with advanced colorectal cancer[1].
  • Provide a new treatment option for patients whose cancer has specific genetic features (MSI-H or dMMR)[1].
  • Work well in combination with other cancer treatments like pembrolizumab[1].

Safety Considerations

As with any medical treatment, there are potential risks and safety considerations:

  • The clinical trial is carefully monitoring for any side effects or safety issues[1].
  • Patients with certain conditions, such as active infections, liver disease, or a history of certain other cancers, may not be eligible for the treatment[1].
  • The treatment may affect fertility, so patients are advised to use effective contraception during and after treatment[1].

It’s important to note that as GAD20-209-FSP-A2 is still in clinical trials, our understanding of its benefits and risks may change as more research is conducted. Patients should always discuss potential treatments with their healthcare provider to understand the most current information and how it applies to their individual situation.

Aspect Details
Study Type Phase I/II, Multi-center, Open-Label Study
Intervention Nous-209 Genetic Vaccine (including Gad20-209-Fsp-A2) + Pembrolizumab
Target Condition Advanced MSI-H or dMMR Colorectal Cancer
Primary Objective Assess anti-tumor activity (ORR) using RECIST v1.1 criteria
Secondary Objectives Evaluate safety, tolerability, and additional efficacy measures (BOR, DoR, PFS)
Key Eligibility Criteria Adults with confirmed MSI-H/dMMR status, adequate organ function, ECOG status 0/1
Administration Route Intramuscular injection

FAQ

  • What is Gad20-209-Fsp-A2? Gad20-209-Fsp-A2 is one of four components in the Nous-209 genetic vaccine. It is derived from a Great Apes Adenovirus and carries genetic material encoding Frame Shift Peptides (FSPs) that may help stimulate the immune system to fight cancer cells.
  • What type of cancer is this trial focusing on? The trial is focusing on locally advanced unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
  • How is the vaccine administered? The Nous-209 vaccine, which includes Gad20-209-Fsp-A2, is administered as an intramuscular injection.
  • What is the main goal of this clinical trial? The main goal is to assess the anti-tumor activity of the vaccination regimen combined with pembrolizumab, measured by the Overall Response Rate (ORR) according to RECIST v1.1 criteria.
  • Who is eligible to participate in this trial? Eligible participants are adults (18 years or older) with confirmed MSI-H or dMMR colorectal cancer, adequate organ function, and a life expectancy of at least 6 months. Specific eligibility criteria vary depending on the trial phase and cohort.

Ongoing Clinical Trials on Gad20-209-Fsp-A2

  • Study of Nous-209 Genetic Vaccine and Pembrolizumab for Patients with Advanced Microsatellite Instability-High Colorectal Cancer

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Italy Spain

Glossary

  • Microsatellite Instability-High (MSI-H): A condition where cells have a high number of genetic mutations in microsatellites, which are short, repeated sequences of DNA. This is often associated with certain types of cancer, including some colorectal cancers.
  • Mismatch Repair Deficient (dMMR): A condition where cells lack the ability to correct mistakes in DNA replication, leading to an accumulation of genetic mutations. This can contribute to the development of certain cancers.
  • RECIST v1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standardized method to measure how well a cancer patient responds to treatment by assessing changes in tumor size.
  • Overall Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Pembrolizumab: An immunotherapy drug that helps the immune system recognize and attack cancer cells.
  • Frame Shift Peptides (FSPs): Small protein fragments resulting from genetic mutations that can be recognized by the immune system as foreign, potentially stimulating an anti-tumor response.
  • Adenovirus: A type of virus that can be modified for use in gene therapy or vaccine development.

References

  1. http://clinicaltrials.eu/trial/study-of-nous-209-genetic-vaccine-and-pembrolizumab-for-patients-with-advanced-microsatellite-instability-high-colorectal-cancer/