A study in people with advanced cancer (solid tumours) to test different doses of BI 3810944 and to find out whether it helps
This is an early-stage study, often called a Phase 1 trial, looking for people with advanced solid tumours, including melanoma. The main goal is to test a new drug, BI 3810944, for the very first time in humans. Researchers will give different doses of the drug to see what amount is safe and well-tolerated. They also want to understand how the drug works in the body and if there are any signs that it might help treat these cancers. Studies like this are important steps in developing new cancer treatments. If you have been diagnosed with an advanced solid tumour or melanoma, your doctor can tell you if this study might be an option for you.
At a glance
What is this study about?
This study is about exploring a new experimental medicine called BI 3810944 for people who have advanced solid tumours. "Advanced solid tumours" means cancers that have grown or spread and are not blood cancers. Melanoma, a type of skin cancer, is one of the specific cancers included. This is a very early study, usually called a Phase 1 trial, which means it's the first time this particular drug is being given to people. This is a crucial step in developing new medicines.
The main aim of this early study is to carefully test different amounts (doses) of BI 3810944. Researchers want to find out what dose is safe and how the body handles the medicine. They will also be looking for any signs that the drug might be effective in treating these cancers. Think of it like taking the first few steps on a long journey to find a new treatment.
Studies like this are vital because they help scientists understand if a new medicine works the way they expect and if it's safe enough to continue testing in larger groups of people. Every new treatment that eventually becomes available starts with studies like this. Your involvement could help advance future cancer treatments.
Key takeaways
- It's an early safety study of a brand-new drug.
- For adults with advanced solid tumours, including melanoma.
- Aims to find a safe dose and look for early signs of effectiveness.
- Your health will be closely watched.
- Participation is voluntary; you can withdraw at any time.
Who may be eligible?
This study is looking for adults who are at least 18 years old. There's no upper age limit, meaning older adults can also take part.
Participants must have a type of cancer called a solid tumour that is considered 'advanced'. This means the cancer has grown or spread in a way that makes it more challenging to treat with standard methods. Melanoma, a skin cancer, is one of the specific types of solid tumour being included.
Both men and women can take part in this study. There will also be other health requirements and medical tests to make sure that joining the study is safe for you. Your study doctor will discuss all these details if you are interested.
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.
- Am I at least 18 years old?
- Have I been diagnosed with an advanced solid tumour (like melanoma)?
- Am I able and willing to attend regular hospital or clinic visits?
- Am I comfortable with receiving an experimental, new medicine?
What does participation involve?
If you decide to take part in this study, you would first have a number of tests and checks to make sure the study is suitable for you. These might include blood tests, scans, and physical examinations. If you qualify, you would receive the study medicine, BI 3810944, at a specific dose. This medicine would likely be given regularly, possibly through a drip or in tablet form, depending on the study design.
You would need to attend regular clinic visits for more blood tests, examinations, and to discuss how you are feeling and any side effects. The frequency of these visits might be more intense at the beginning and then become less frequent over time. There would also be follow-up appointments after you stop taking the study medicine. The total length of your participation would depend on how your body responds to the treatment and the specific study plan, but early-stage studies can often last several months.
Potential risks and benefits
Locations (2)
- —UnverifiedBelgium
- —UnverifiedNetherlands
Common questions
What does 'advanced solid tumour' mean?
It means cancer that has grown or spread from its original site to other parts of the body, and it's not a blood cancer.
What is a 'Phase 1' study?
It's the very first stage where a new medicine is given to people. The main goals are to check its safety, find the best dose, and see how the body handles it.
Will I definitely get the new drug?
Yes, in this type of study, all participants usually receive the new experimental drug, unlike some later studies where you might get a placebo.
How long would I be in the study?
The exact length varies for each person, but early-stage studies often involve several months of active treatment and follow-up appointments.
Can I stop being part of the study once I've started?
Yes, you can choose to leave the study at any time, and you don't have to give a reason. Your decision won't affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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