In short
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.
At a glance
- 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
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. 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.
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:
- It introduces specific proteins (peptides) that are similar to those found on cancer cells.
- These proteins stimulate the immune system, particularly T cells, which are a type of white blood cell that helps fight disease.
- 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.
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.
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)
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:
- Screening: Patients are tested to see if they qualify for the study.
- Treatment Phase: Patients receive the study treatment and undergo regular check-ups. This phase is expected to last up to 43 weeks.
- Follow-up: After treatment ends, patients are monitored for safety and to see how well the treatment worked.
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
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
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.
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.