A study to test different doses of BI 3923948 alone and in combination with an anti-PD-1 antibody in people with different types of advanced cancer (solid tumors)
This research study is looking at a new medicine called BI 3923948. It's being tested in adults who have different types of advanced cancer that has either spread to other parts of the body (metastatic) or can't be surgically removed (unresectable). The study will check how safe the new medicine is and how the body handles different amounts (doses) of it. Researchers will also look at whether it works better when given together with an existing cancer drug called an anti-PD-1 antibody. This is one of the first times this new medicine is being given to people, so it's mainly about understanding its basic effects and safety.
At a glance
What is this study about?
This study is a very early stage of research, often called a Phase I trial. This means it's one of the first times a new medicine, known as BI 3923948, is being given to people. The main aim is to carefully check if the medicine is safe and to find the right amount (dose) that can be given without causing too many problems. It also helps researchers understand how the medicine moves through and affects the body.
The study involves people who have advanced cancer. This means their cancer has grown and spread to other areas, or it's in a place where surgery to remove it isn't possible. The researchers are testing BI 3923948 in two ways: first, on its own, and then alongside another type of cancer treatment called an anti-PD-1 antibody. These antibodies work by helping your body's immune system fight cancer.
By taking part, you would be helping doctors learn more about this new treatment. This kind of research is vital for developing new ways to fight cancer in the future, even if the direct benefits to you aren't yet clear. It helps gather important information that can lead to larger studies and potentially new treatments for many people.
Key takeaways
- This is an early-stage study testing a new cancer medicine.
- It's for adults with advanced cancers that have spread or can't be removed.
- The main goals are to check safety and find the right dose.
- Some people might get the new medicine with another cancer drug.
- Participation involves regular hospital visits for treatment and monitoring.
- You can stop participating 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, meaning adults of any age can potentially take part. Both men and women are welcome to participate.
The study is specifically for people who have advanced solid tumours. This means your cancer is no longer confined to one area and has either spread to different parts of your body, or doctors have decided it cannot be removed by an operation.
Other health conditions or previous treatments might affect whether you can join, so the study doctors will review your full medical history carefully.
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?
- Do you have advanced cancer that has spread or can't be surgically removed?
- Are you able to attend regular hospital appointments?
- Are you willing to follow the study's treatment and monitoring plan?
What does participation involve?
If you decide to take part, you would receive the study medication, BI 3923948, either on its own or in combination with an anti-PD-1 antibody. This will involve regular visits to the hospital or clinic. These visits will include checks like blood tests, physical examinations, and scans to see how you are responding to the treatment and to monitor for any side effects.
As this is an early-stage study, the exact number and frequency of visits, as well as the total length of time you'll be involved, will vary. However, you should expect to attend regularly for treatment and monitoring over a period that could last several months or longer. Doctors and nurses will explain the full schedule to you before you agree to participate.
Potential risks and benefits
Locations (4)
- —UnverifiedSweden
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedGermany
Common questions
What does 'advanced solid tumours' mean?
It means the cancer has either spread to other parts of your body, or it's a type that doctors can't remove with surgery.
What is an anti-PD-1 antibody?
It's a type of cancer medicine that helps your body's own immune system find and fight cancer cells.
Will I get the new medicine or the combination?
The study will decide which treatment you receive. You might get the new medicine alone or combined with the antibody.
Who is paying for this study?
Clinical trials are typically funded by pharmaceutical companies, government bodies, or research organisations.
What if I experience side effects?
The study team will closely monitor you and provide care for any side effects. You should always tell them about anything new or unusual you feel.
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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