In short
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.
At a glance
- 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
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. This vaccine is made up of several components, including something called OMP11, which is one of the active ingredients.
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.
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.
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
- Have already tried other standard treatments, or aren't suitable for those treatments
- Are 18 years or older
- Have a good overall health status (doctors use a scale called ECOG to measure this)
- Have a specific genetic marker called HLA-A2
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.
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.
The study is testing EO4010 in different ways:
- By itself
- Combined with another drug called nivolumab (which helps the immune system fight cancer)
- Combined with nivolumab and a drug called bevacizumab (which affects blood vessel growth in tumors)
- Combined with just bevacizumab
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.
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
- Improving survival time
- Controlling the disease for a longer time
The study will measure these outcomes to see how effective the treatment is.
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.
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.