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Omp12

The AUDREY study is a global multicenter phase 1/2 clinical trial investigating the use of EO4010, a novel microbial-derived peptide therapeutic vaccine containing OMP12, in combination with nivolumab and/or bevacizumab for patients with previously treated metastatic colorectal carcinoma. This trial aims to evaluate the safety, tolerability, and potential effectiveness of this innovative combination therapy in patients who have limited treatment options.

Table of Contents

What is EO4010?

EO4010 is a new type of cancer treatment called a microbial-derived peptide therapeutic vaccine. It is being studied for patients with metastatic colorectal cancer (mCRC) who have already received other treatments[1]. This innovative therapy is designed to help the body’s immune system fight cancer cells more effectively.

EO4010 contains several active substances, including:

  • UCP2
  • EO2317
  • EO2318
  • OMP10
  • OMP11
  • OMP12

These substances are proteins or protein-like molecules that are intended to stimulate the immune system to recognize and attack cancer cells[1].

How Does EO4010 Work?

EO4010 works as a cancer vaccine. Unlike vaccines that prevent diseases, cancer vaccines are designed to treat existing cancer. Here’s how EO4010 is thought to work:

  1. It introduces specific proteins (peptides) that are similar to those found on cancer cells.
  2. These proteins stimulate the immune system, particularly T cells, which are a type of white blood cell that helps fight disease.
  3. The activated T cells learn to recognize and attack cancer cells that have similar proteins.

In the clinical trial, EO4010 is being tested alone and in combination with other cancer drugs:

  • Nivolumab: An immunotherapy drug that helps the immune system attack cancer cells.
  • Bevacizumab: A drug that stops the growth of blood vessels that feed tumors[1].

Who is EO4010 For?

EO4010 is being studied for patients with:

  • Metastatic colorectal cancer (mCRC): This is cancer that started in the colon or rectum and has spread to other parts of the body.
  • Cancer that is unresectable (cannot be removed by surgery) and has been previously treated.
  • Cancer that is mismatch repair proficient and microsatellite stable: These are specific characteristics of the cancer cells[1].

Patients must also:

  • Be 18 years or older
  • Have an ECOG performance status of 0 to 1 (able to perform daily activities with little to no assistance)
  • Be HLA-A2 positive (have a specific protein on their cells that helps the immune system recognize foreign substances)[1]

Clinical Trial Details

The clinical trial for EO4010 is called the “AUDREY” study. It is a global, multicenter Phase 1/2 trial. The study is divided into several parts:

  1. Screening: Patients are tested to see if they qualify for the study.
  2. Treatment Phase: Patients receive the study treatment and undergo regular check-ups. This phase is expected to last up to 43 weeks.
  3. Follow-up: After treatment ends, patients are monitored for safety and to see how well the treatment worked[1].

The study includes different groups (cohorts) of patients:

  • Cohort 1: Tests EO4010 alone, then with nivolumab
  • Cohort 2: Tests EO4010 with nivolumab
  • Cohort 3: Tests EO4010 with nivolumab and bevacizumab, or with bevacizumab alone[1]

Potential Benefits

While it’s important to note that EO4010 is still being studied and its effectiveness is not yet proven, the researchers hope to see benefits such as:

  • Tumor shrinkage (objective response rate)
  • Disease control (stopping the cancer from growing)
  • Longer time before the cancer gets worse (progression-free survival)
  • Improved overall survival[1]

Safety and Side Effects

A main goal of this study is to evaluate the safety of EO4010. The researchers will closely monitor patients for any side effects or adverse events. Common side effects of cancer treatments can include fatigue, nausea, and changes in blood cell counts, but the specific side effects of EO4010 are not yet known[1].

Patients in the study will have regular check-ups and tests to monitor their health and the effects of the treatment. It’s important for patients to report any unusual symptoms or changes in their health to their healthcare team promptly.

Aspect Details
Study Name AUDREY Study
Study Type Phase 1/2 clinical trial
Main Treatment EO4010 (containing OMP12) 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, objective response rate, disease control rate, progression-free survival, and overall survival
Key Eligibility Criteria HLA-A2 positive, advanced non-resectable colorectal adenocarcinoma, mismatch repair proficient, microsatellite stable
Study Design Three cohorts with different combination therapies
Treatment Duration Expected to complete by week 43, with potential for continuation
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 OMP12) in combination with nivolumab and/or bevacizumab in patients with previously treated, advanced colorectal cancer.
  • Who is eligible to participate in this clinical trial? Eligible participants are HLA-A2 positive patients aged 18 or older with advanced non-resectable colorectal adenocarcinoma that is mismatch repair proficient and microsatellite stable. They must have been previously treated with standard therapies or are not considered candidates for such therapies.
  • What are the main components of the treatment being studied? The main components of the treatment being studied are EO4010 (a novel microbial-derived peptide therapeutic vaccine containing OMP12), nivolumab (an immune checkpoint inhibitor), and bevacizumab (an anti-VEGF agent). These may be used alone or in combination depending on the study cohort.
  • How long does the treatment phase of the study last? The treatment phase of the study is expected to be completed by week 43. However, patients may continue treatment as long as they benefit from it, until disease progression, or until they decide to stop or leave the study.
  • 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 dose. If the disease has not progressed, follow-up visits will be 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.

Ongoing Clinical Trials on Omp12

  • 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 OMP12, which is the focus of this summary.
  • OMP12: One of the active substances in EO4010, classified as a protein-based component of the therapeutic vaccine.
  • Metastatic colorectal carcinoma (mCRC): An advanced stage of colorectal cancer where the cancer has spread from the colon or rectum to other parts of the body.
  • Nivolumab: An immune checkpoint inhibitor drug that helps the immune system fight cancer cells.
  • Bevacizumab: An anti-VEGF (Vascular Endothelial Growth Factor) agent that helps prevent the growth of blood vessels that supply tumors.
  • HLA-A2: A specific type of Human Leukocyte Antigen, which is important for the immune system's ability to recognize and respond to the vaccine.
  • 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 cancer cells that do not have high levels of genetic instability in certain repeated DNA sequences called microsatellites.
  • ECOG performance status: A scale used to assess how a patient's disease is progressing and how it affects daily living abilities.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with the disease without it worsening.
  • Overall survival (OS): The length of time from the start of treatment that patients diagnosed with the disease are still alive.
  • Objective response rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Disease control rate (DCR): The percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response, and stable disease.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment.
  • iRECIST: A modified version of RECIST criteria specifically designed for immunotherapy trials.

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/