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Gad20-209-Fsp-A4

This article discusses the clinical trials of GAd20-209-FSP, an innovative genetic vaccine being studied for the treatment of microsatellite unstable solid tumors, particularly in patients with advanced colorectal cancer. The trials aim to assess the safety, tolerability, and effectiveness of this vaccine when used in combination with pembrolizumab, an immunotherapy drug.

Table of Contents

What is GAD20-209-FSP-A4?

GAD20-209-FSP-A4 is part of a genetic vaccine called Nous-209, which is being studied for the treatment of certain types of cancer[1]. This vaccine is considered an advanced therapy, specifically a gene therapy product. It’s important to note that GAD20-209-FSP-A4 is one of four components that make up the complete Nous-209 vaccine[1].

How Does It Work?

The Nous-209 vaccine, which includes GAD20-209-FSP-A4, works in a unique way:

  • It’s based on a virus called adenovirus, specifically one found in great apes (GAd20)[1].
  • The vaccine carries genetic material that encodes for 209 Frame Shift Peptides (FSPs). These are special proteins that are often found in certain types of cancer cells[1].
  • When introduced into the body, it’s designed to stimulate the immune system to recognize and attack cancer cells that have these specific proteins[1].
This approach is a form of immunotherapy, which means it uses the body’s own immune system to fight cancer.

Target Conditions

The Nous-209 vaccine, including GAD20-209-FSP-A4, is being studied for the treatment of:

  • Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer that is locally advanced and can’t be surgically removed, or has spread to other parts of the body (metastatic)[1].
These terms (MSI-H and dMMR) refer to specific genetic characteristics of the cancer that make it potentially responsive to this type of treatment[1].

Clinical Trial Information

The vaccine is currently being studied in a clinical trial:

  • It’s a Phase I/II trial, which means it’s testing both the safety and how well the treatment works[1].
  • The trial is testing the vaccine in combination with another drug called pembrolizumab, which is also an immunotherapy[1].
  • The main goal is to see how many patients respond to the treatment (called the Overall Response Rate or ORR)[1].
  • The trial is also looking at how safe the treatment is and how long the responses last[1].

Eligibility Criteria

To participate in the trial, patients must meet certain criteria. Some key points include:

  • Be 18 years or older[1].
  • Have confirmed MSI-H or dMMR colorectal cancer[1].
  • Have cancer that can’t be surgically removed or has spread[1].
  • Have a life expectancy of at least 6 months[1].
  • Have good overall health and organ function[1].
There are also several conditions that would prevent a person from participating, such as certain other medical conditions or previous treatments[1].

Potential Benefits and Risks

As with any experimental treatment, there are potential benefits and risks:

  • Potential benefits: The treatment might help slow down or stop the growth of cancer, or even shrink tumors in some patients[1].
  • Potential risks: The treatment might cause side effects. The trial is carefully monitoring for any adverse events[1].
It’s important to note that as this is an experimental treatment, not all potential risks are known, and the benefits are not guaranteed[1].

Aspect Details
Study Type Phase I/II, Multi-center, Open-Label Study
Investigational Drug GAd20-209-FSP (Nous-209) Genetic Vaccine
Target Condition Microsatellite Unstable Solid Tumors, specifically MSI-H or dMMR Colorectal Cancer
Combination Therapy GAd20-209-FSP + Pembrolizumab
Primary Endpoint Overall Response Rate (ORR) assessed by RECIST v1.1 criteria
Key Secondary Endpoints Safety, tolerability, Best Overall Response, Duration of Response, Progression-Free Survival
Administration Route Intramuscular injection
Key Eligibility Criteria Age ≥18 years, confirmed MSI-H or dMMR status, adequate organ function, ECOG performance status 0/1

FAQ

  • What is GAd20-209-FSP? GAd20-209-FSP is a genetic vaccine composed of four vectors derived from Great Apes Adenovirus 20. It carries genetic material encoding 209 Frame Shift Peptides (FSPs), which are designed to target microsatellite unstable solid tumors.
  • What type of cancer is being targeted in these trials? The trials are primarily focusing on patients with locally advanced unresectable or metastatic, microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC).
  • How is the vaccine administered? GAd20-209-FSP is administered as an intramuscular injection.
  • What is the main objective of the Phase II trials? The main objective is to assess the preliminary evidence of anti-tumor activity of the vaccination regimen plus pembrolizumab, measured by the Overall Response Rate (ORR) using RECIST v1.1 criteria.
  • Who is eligible to participate in these trials? Eligible participants include 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 between different cohorts of the study.

Ongoing Clinical Trials on Gad20-209-Fsp-A4

  • 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, particularly colorectal cancer.
  • Mismatch Repair Deficient (dMMR): A condition where cells lack the ability to correct mistakes made during DNA replication, leading to an accumulation of mutations. This is closely related to MSI-H status.
  • RECIST v1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standard set of rules used to measure how well a cancer patient responds to treatment.
  • Overall Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Pembrolizumab: An immunotherapy drug that helps the immune system detect and fight cancer cells.
  • Frame Shift Peptides (FSPs): Abnormal protein fragments resulting from genetic mutations that cause a shift in the reading frame of DNA, often found in microsatellite unstable tumors.
  • Adenovirus vector: A modified virus used to deliver genetic material into cells as part of gene therapy or vaccination.

References

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