A phase 1, open-label, dose-escalation and dose-expansion study evaluating the safety, feasability and efficacy of ODI-2001 vaccine, a personalized immunotherapy, in patients with metastatic or locally advanced colon cancer of pancreatic cancer
This study is looking at a new, personalised treatment called ODI-2001, which is a type of vaccine. It's designed to help the body's own defence system fight advanced bowel cancer (colorectal cancer) or advanced pancreatic cancer that has spread or is hard to remove. This is an early-stage study, meaning it's one of the first times this treatment is being given to people. The main goals are to check if it's safe, how the body reacts to different doses, and to get an early idea of how effective it might be. Researchers also want to learn how practical it is to use this new treatment. We are not yet sure how well it works, but this study is an important step to find out more for future patients.
At a glance
What is this study about?
This research is focused on a new type of treatment for advanced bowel cancer (also known as colorectal cancer) and advanced pancreatic cancer. These are cancers that have either spread to other parts of the body (metastatic) or are in an advanced stage that makes them difficult to treat with standard methods. The new treatment being tested is called ODI-2001, and it's described as a 'personalised immunotherapy vaccine'.
What does 'personalised immunotherapy vaccine' mean? It means this treatment is created specifically for each patient, using information from their own cancer. The idea behind it is to teach your body's immune system – your natural defence against illness – to recognise and fight your cancer cells more effectively. Instead of a regular vaccine that prevents disease, this is designed to help treat an existing one.
This is a 'Phase 1' study, which is the very first stage of testing a new medicine in people. At this stage, the main goals are to make sure the treatment is safe, find the right dose to use, and see if it's possible to give this treatment in a practical way. While researchers will also be looking for any signs that it might be working against the cancer, the primary focus is on safety and understanding how the body reacts to this new vaccine.
Key takeaways
- This study tests a new personalised vaccine (ODI-2001) for advanced bowel or pancreatic cancer.
- It's a 'Phase 1' study, focusing on safety, finding the right dose, and basic feasibility.
- The vaccine aims to help your immune system fight your specific cancer.
- Participation involves receiving the new treatment and close monitoring.
- Potential benefits include early access to new treatment, but risks include unknown side effects.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.
The main requirement for joining is that you have either advanced bowel cancer or advanced pancreatic cancer. This means your cancer has either spread to other parts of your body, or it's a type of cancer that is located in an area that makes it hard to treat with regular surgery or other common methods.
There will be other important health checks and guidelines that the study doctors will go through with you to make sure it's safe for you to take part. These will help them decide if this study is the right fit for your situation.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with advanced bowel (colorectal) cancer?
- Have you been diagnosed with advanced pancreatic cancer?
- Has your cancer spread or is it hard to treat with standard methods?
- Are you able to attend regular hospital appointments?
What does participation involve?
If you decide to take part in this study, the doctors and nurses will explain everything in detail. Because this is an early-stage study, you would likely have regular visits to the clinic for check-ups, blood tests, and to receive the study treatment. The treatment would involve getting the ODI-2001 vaccine. The exact number of visits and the full duration of your participation would be discussed with you, but typically, early-stage studies can involve a period of active treatment followed by monitoring appointments to keep an eye on your health and check how the treatment is affecting you over time.
Potential risks and benefits
Locations (1)
- —UnverifiedFrance
Common questions
What is a 'personalised' vaccine?
It means the vaccine is designed specifically for you, using information from your own cancer, to help your body's defence system recognise and fight it.
What kind of cancer is this study for?
It's for people with advanced bowel (colorectal) cancer or advanced pancreatic cancer that has spread or is hard to treat.
What does 'Phase 1' mean for a study?
It's the very first stage where a new treatment is tried in people. The main goals are to check if it's safe and find the right dose, rather than how well it works yet.
Will this study cure my cancer?
It's too early to say if this treatment will cure cancer. This study aims to understand its safety and how it works, not to guarantee a cure.
Can anyone join this study?
Only adults (18+) with advanced bowel or pancreatic cancer may be eligible. There will be other specific health checks to see if it's right for you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.