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Gad20-209-Fsp-A3

This article discusses the clinical trials of GAd20-209-FSP, a genetic vaccine being studied for the treatment of advanced microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. The trials aim to assess the safety, tolerability, and effectiveness of this innovative therapy when combined with pembrolizumab, an immunotherapy drug.

Table of Contents

What is GAD20-209-FSP-A3?

GAD20-209-FSP-A3 is part of a genetic vaccine called Nous-209, which is being developed to treat certain types of advanced cancer[1]. This vaccine is made up of four components, including GAD20-209-FSP-A1, GAD20-209-FSP-A2, GAD20-209-FSP-A3, and GAD20-209-FSP-A4. Together, these components form a solution that is injected into the muscle to stimulate the immune system against cancer cells[1].

How Does It Work?

The GAD20-209-FSP-A3 vaccine is based on a modified adenovirus, which is a type of virus that has been engineered to deliver genetic material into the body[1]. This genetic material encodes for 209 Frame Shift Peptides (FSPs), which are abnormal proteins found in certain types of cancer cells[1].

When injected, the vaccine teaches the immune system to recognize these abnormal proteins, potentially helping it to identify and attack cancer cells that produce them. This approach is known as immunotherapy, as it uses the body’s own immune system to fight cancer[1].

What Conditions Does It Treat?

The GAD20-209-FSP-A3 vaccine is being studied for the treatment of advanced colorectal cancer with specific characteristics[1]. Specifically, it targets:

  • Locally advanced unresectable or metastatic colorectal cancer: This means cancer that has spread beyond the colon or rectum and cannot be removed surgically[1].
  • Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors: These are specific genetic features found in some colorectal cancers that make them potentially more responsive to immunotherapy[1].

Clinical Trial Information

The GAD20-209-FSP-A3 vaccine is currently being studied in a clinical trial. Here are some key points about the trial[1]:

  • It’s a Phase I/II trial, which means it’s testing both the safety and effectiveness of the treatment.
  • The trial is open-label, meaning both patients and doctors know which treatment is being given.
  • The vaccine is being studied in combination with another drug called pembrolizumab, which is an existing immunotherapy treatment.
  • The main goal is to see if the combination of the vaccine and pembrolizumab can shrink tumors or slow down cancer growth.

Eligibility Criteria

To participate in the trial, patients must meet certain criteria. Some key eligibility requirements include[1]:

  • Being 18 years or older
  • Having advanced colorectal cancer that is MSI-H or dMMR
  • Having cancer that can be measured on scans
  • Being in relatively good overall health
  • Not having certain other medical conditions or previous treatments that could interfere with the study

Potential Benefits and Risks

As with any experimental treatment, there are potential benefits and risks to consider[1]:

Potential benefits:

  • The treatment may help slow down or stop cancer growth
  • It may shrink tumors
  • It could potentially improve survival for patients with advanced colorectal cancer

Potential risks:

  • Side effects from the vaccine or pembrolizumab
  • The treatment may not work as well as hoped
  • There may be unknown risks, as this is an experimental treatment

It’s important to discuss these potential benefits and risks thoroughly with a healthcare provider before considering participation in the clinical trial[1].

Aspect Details
Study Type Phase I/II, Multi-center, Open-Label Study
Treatment GAd20-209-FSP genetic vaccine + pembrolizumab
Target Condition Advanced MSI-H or dMMR Colorectal Cancer
Primary Objective Assess anti-tumor activity (ORR)
Secondary Objectives Safety, tolerability, BOR, DoR, PFS
Key Eligibility Criteria Age ≥18, MSI-H/dMMR status, adequate organ function
Administration Route Intramuscular injection

FAQ

  • What is GAd20-209-FSP? GAd20-209-FSP is a genetic vaccine composed of four vectors derived from a Great Apes Adenovirus. It carries genetic material encoding 209 Frame Shift Peptides (FSPs), which are designed to target specific cancer cells.
  • What type of cancer is this treatment being studied for? The treatment is being studied for locally advanced unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
  • How is the vaccine administered? The vaccine is administered through intramuscular injection, meaning it's injected directly into the muscle.
  • What is the main goal of the clinical trials? The main goal is to assess the anti-tumor activity of the GAd20-209-FSP vaccination regimen combined with pembrolizumab, primarily by measuring the overall response rate (ORR) of patients.
  • 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 phases and cohorts of the study.

Ongoing Clinical Trials on Gad20-209-Fsp-A3

  • 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 changes in areas of repeated DNA sequences called microsatellites. This is often associated with defects in the ability to repair DNA mistakes.
  • Mismatch Repair Deficient (dMMR): A condition where cells lack the ability to correct small errors that occur during DNA replication, leading to an accumulation of mutations.
  • Frame Shift Peptides (FSPs): Protein fragments resulting from genetic mutations that alter the normal reading frame of a gene, potentially creating new targets for the immune system to recognize in cancer cells.
  • Pembrolizumab: An immunotherapy drug that helps the immune system detect and fight cancer cells by blocking a protein called PD-1.
  • Overall Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • RECIST v1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standard way to measure how well a cancer patient responds to treatment.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease without it getting worse.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status: A scale used to assess how a patient's disease is progressing and how it affects daily living abilities.

References

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