A Study of LY4257496 in Participants With Cancer (OMNIRAY)
This research study, called OMNIRAY, is looking at a new investigational medication, LY4257496, for individuals diagnosed with specific cancers. These include breast cancer, bowel cancer (colorectal neoplasms), prostate cancer, and womb cancer (endometrial neoplasms), particularly when the cancer has spread to other parts of the body (metastasis). This is a very early-stage study, known as Phase I, which means it's the first time this new medicine is being given to people. The main goal at this stage is to find out if the medicine is safe, how much can be given, and how it acts within the body. It helps researchers understand how the medicine works before it can be tested in larger groups of people. Participants must be 18 years or older, and both men and women can take part.
At a glance
What is this study about?
This research study is called OMNIRAY, and it's looking into a new medication known as LY4257496. This medicine is still experimental, meaning it hasn't been approved for general use yet. The scientists want to see how it works in people who have specific types of cancer. These include breast cancer, bowel cancer (also called colorectal cancer), prostate cancer, and womb cancer (also known as endometrial cancer). They are particularly interested in cases where the cancer has spread to other parts of the body, which is called metastasis.
This is a very early step in testing new medicines, called a 'Phase I' study. Think of it like taking a new car for its very first test drive. Because it's a new medicine never given to humans before, the main aim is to make sure it's safe for people. Doctors will be very carefully monitoring participants to see if there are any side effects and to understand how the body handles the medicine. They also want to find the right dose that can be given.
Understanding how a new medicine acts in the body is really important. The information gathered from this early stage helps researchers decide if the medicine is promising enough to be tested in more people and to see if it can actually help treat cancer. Your participation would help gather crucial information that could lead to new treatments in the future.
Key takeaways
- This study is testing a completely new medicine for certain cancers.
- It's a very early-stage trial (Phase I), focusing on safety and how the medicine works in the body.
- People with breast, bowel, prostate, or womb cancer (especially if it has spread) might be eligible.
- Participants must be 18 years or older; both men and women can join.
- You'll have frequent check-ups to monitor your health and the medicine's effects.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old. There's no upper age limit, so people of all adult ages can be considered. The study is open to both men and women.
Crucially, you must have been diagnosed with one of the specific types of cancer that the study is focusing on. These include breast cancer, bowel cancer, prostate cancer, or womb cancer. The study is particularly looking for people where the cancer has spread to other parts of the body.
While these are the main points, there will be other specific health requirements and tests to make sure the study medicine is right and safe for you. Your cancer specialist will be able to check if you meet all the necessary criteria.
- Are you 18 years old or older?
- Do you have breast, bowel, prostate, or womb cancer?
- Has your cancer spread to other parts of your body?
- Are you willing to have regular hospital visits and tests?
- Are you able to take an investigational medicine as prescribed?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will be given the new study medicine, LY4257496. Because this is a very early-stage study, you can expect frequent visits to the clinic, especially at the beginning. This is so the medical team can keep a close eye on you, monitor your health, and check for any side effects.
During these visits, you will likely have various assessments, which might include blood tests, urine tests, physical examinations, and possibly scans or other tests related to your cancer. These tests help doctors understand how your body is reacting to the medicine and how the medicine is working. You will be given clear instructions on how to take the medicine, and you'll have regular contact with the study team.
The total duration of your participation will depend on how you respond to the medicine and if there are any side effects. There might also be a follow-up period after you stop taking the medicine to ensure your continued well-being. All the details would be fully explained to you before you agree to join.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What does 'Phase I' mean for this study?
Phase I means this is the first time this new medicine is being tested in people. The main goals are to make sure it's safe, find the right dose, and see how it behaves in the body.
Will this medicine cure my cancer?
It's too early to say if this medicine will cure cancer. The study aims to understand its safety and how it works. While there's a chance it could have a positive effect, there's no guarantee at this stage.
What kind of cancer is this study for?
This study is for people with breast cancer, bowel cancer, prostate cancer, or womb cancer, especially if the cancer has spread.
Can I stop being in the study if I want to?
Yes, taking part in a study is completely voluntary. You can decide to leave the study at any time, for any reason, and it won't affect your future medical care.
Why is it important to test new medicines like this?
Testing new medicines like LY4257496 helps doctors find new ways to treat cancer. These early studies are crucial steps in developing potential new treatments for the future.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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