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Omp11

The AUDREY study is a global multicenter phase 1/2 clinical trial exploring the potential of EO4010, a novel microbial-derived peptide therapeutic vaccine containing Omp11, in combination with nivolumab and/or bevacizumab for patients with previously treated metastatic colorectal carcinoma. This groundbreaking research aims to evaluate the safety, tolerability, and efficacy of this innovative treatment approach for patients who have limited options after standard therapies.

Table of Contents

What is EO4010?

EO4010 is a new type of cancer treatment called a therapeutic vaccine. It’s being studied for patients with metastatic colorectal cancer (cancer that has spread from the colon or rectum to other parts of the body) who have already received other treatments[1]. This vaccine is made up of several components, including something called OMP11, which is one of the active ingredients[1].

How does EO4010 work?

EO4010 is designed to work with your immune system to fight cancer. It’s called a microbial-derived peptide therapeutic vaccine, which means it’s made from small pieces of proteins that come from microbes (tiny organisms like bacteria). These proteins are chosen because they look similar to proteins found on cancer cells[1].

The idea is that when your immune system learns to recognize and attack these vaccine proteins, it will also be better at recognizing and attacking similar proteins on your cancer cells. This is a way of “training” your immune system to fight the cancer more effectively[1].

Who is EO4010 for?

The current study is looking at EO4010 for people who meet these criteria:

  • Have advanced colorectal cancer that can’t be removed by surgery and has spread to other parts of the body[1]
  • Have already tried other standard treatments, or aren’t suitable for those treatments[1]
  • Are 18 years or older[1]
  • Have a good overall health status (doctors use a scale called ECOG to measure this)[1]
  • Have a specific genetic marker called HLA-A2[1]

There are also some reasons why a person might not be able to participate in the study, such as having certain other medical conditions or having received specific treatments recently[1].

Clinical Trial Details

The study of EO4010 is called the “AUDREY” study. It’s a phase 1/2 trial, which means it’s an early stage of testing in humans. The main goals are to check if the treatment is safe and to see how well it works[1].

The study is testing EO4010 in different ways:

  1. By itself
  2. Combined with another drug called nivolumab (which helps the immune system fight cancer)
  3. Combined with nivolumab and a drug called bevacizumab (which affects blood vessel growth in tumors)
  4. Combined with just bevacizumab[1]

Patients in the study will receive the treatment and have regular check-ups. The treatment phase is expected to last about 43 weeks, but patients might continue longer if they’re benefiting from the treatment[1].

Potential Benefits

While it’s too early to know for sure how well EO4010 works, the researchers are looking at several potential benefits:

  • Shrinking tumors or slowing their growth[1]
  • Improving survival time[1]
  • Controlling the disease for a longer time[1]

The study will measure these outcomes to see how effective the treatment is[1].

Safety and Side Effects

A major goal of this study is to check the safety of EO4010. The researchers will carefully monitor patients for any side effects or adverse reactions. They’ll use a standardized system to grade any side effects that occur[1].

It’s important to note that as this is a new treatment, not all possible side effects are known yet. This is why the study includes close monitoring and follow-up visits even after the treatment ends[1].

Aspect Details
Study Name AUDREY Study
Study Type Phase 1/2 clinical trial
Main Treatment EO4010 (containing Omp11) in combination with nivolumab and/or bevacizumab
Target Condition Previously treated metastatic colorectal carcinoma
Primary Objective Evaluate safety and tolerability of the combination therapy
Secondary Objectives Assess immunogenicity, tumor response, progression-free survival, and overall survival
Key Eligibility Criteria HLA-A2 positive, advanced colorectal cancer, previously treated, ECOG status 0-1
Study Design Multiple cohorts with different treatment combinations
Treatment Duration Expected to be completed by week 43
Follow-up Safety visits at 30 and 100 days post-treatment, then every 8 weeks

FAQ

  • What is the main purpose of the AUDREY study? The main purpose of the AUDREY study is to evaluate the safety and tolerability of EO4010 (which contains Omp11) in combination with nivolumab and/or bevacizumab in patients with previously treated, unresectable locally advanced or metastatic colorectal cancer.
  • Who is eligible to participate in this clinical trial? Eligible participants are HLA-A2 positive patients, 18 years or older, with advanced non-resectable colorectal adenocarcinoma that is mismatch repair proficient and microsatellite stable. They should have been previously treated with standard therapies or are not considered candidates for such therapies, and have an ECOG performance status of 0 to 1.
  • What are the main components of the treatment being studied? The treatment being studied combines EO4010 (a novel microbial-derived peptide therapeutic vaccine containing Omp11) with nivolumab (an immune checkpoint inhibitor) and/or bevacizumab (an anti-VEGF agent). The study aims to assess how these components work together in treating advanced colorectal cancer.
  • How long does the treatment phase of the study last? The treatment phase of the study is expected to be completed by week 43. Patients will receive regularly scheduled visits to receive study treatment and undergo procedures as described in the protocol. The treatment continues as long as the patient benefits from it, unless the disease worsens or other factors lead to discontinuation.
  • What happens after the treatment phase ends? After the treatment phase, there are follow-up safety visits at 30 and 100 days after the last doses of EO4010 and nivolumab, respectively. If the disease hasn't worsened, follow-up visits are scheduled every 8 weeks to assess the patient's health and any side effects. After disease progression, follow-up visits continue every 8 weeks to monitor the patient's overall health and gather information about any cancer-related medications.

Ongoing Clinical Trials on Omp11

  • Study on EO4010 Vaccine with Nivolumab and Bevacizumab for Patients with Metastatic Colorectal Cancer Who Have Already Received Treatment

    Not recruiting

    2 1 1 1
    Investigated drugs:
    France Spain

Glossary

  • EO4010: A novel microbial-derived peptide therapeutic vaccine being studied in the AUDREY trial. It contains several components, including Omp11, and is administered as an emulsion for injection.
  • Omp11: One of the active substances in EO4010, classified as a protein. It is being studied as part of the combination therapy for advanced colorectal cancer.
  • Metastatic colorectal cancer: A type of cancer that starts in the colon or rectum and has spread to other parts of the body.
  • HLA-A2: A specific type of human leukocyte antigen (HLA) that patients must possess to be eligible for this study. HLAs are proteins on cells that help the immune system identify foreign substances.
  • Nivolumab: An immune checkpoint inhibitor drug used in combination with EO4010 in this study. It works by helping the immune system recognize and attack cancer cells.
  • Bevacizumab: An anti-VEGF (vascular endothelial growth factor) agent used in some arms of this study. It works by inhibiting the growth of blood vessels that feed tumors.
  • ECOG performance status: A scale used to assess how a patient's disease is progressing and how it affects daily living abilities. In this study, patients must have a status of 0 to 1 to be eligible.
  • Mismatch repair proficient: A characteristic of cancer cells that can effectively repair DNA mismatches, making them less responsive to certain types of immunotherapy.
  • Microsatellite stable: A characteristic of tumors that do not have high levels of genetic instability in areas called microsatellites. This status can affect how tumors respond to certain treatments.
  • Immunogenicity: The ability of a substance to provoke an immune response in the body. In this study, it refers to the vaccine's ability to stimulate T cells against specific peptides.
  • T cells: A type of white blood cell that plays a central role in immune response. The study aims to evaluate how EO4010 affects T cell responses against cancer-associated antigens.
  • Tumor associated antigens (TAAs): Proteins that are present on tumor cells and can be recognized by the immune system. The study assesses T cell cross-reactivity with human TAAs.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with the disease without it worsening. This is one of the secondary endpoints of the study.
  • RECIST 1.1 and iRECIST criteria: Standardized guidelines used to measure tumor response in cancer clinical trials. These criteria help determine if the cancer is responding to treatment, staying the same, or getting worse.

References

  1. http://clinicaltrials.eu/trial/study-on-eo4010-vaccine-with-nivolumab-and-bevacizumab-for-patients-with-metastatic-colorectal-cancer-who-have-already-received-treatment/