A study in patients with different types of advanced cancer (solid tumors) to test different doses of BI 907828 (brigimadlin) in combination with BI 754091 (ezabenlimab) and BI 754111 or BI 907828 (brigimadlin) in combination with BI 754091 (ezabenlimab)
This research study is looking for adults aged 18 and over who have advanced solid tumors, which means their cancer has grown or spread. The main goal is to find out the safest and most effective dose of a new experimental drug called Brigimadlin when it's given along with another drug called Ezabenlimab. In some cases, a third experimental drug might also be tested. This is a very early stage of research, called Phase I, which helps doctors understand how these new medicines work in the human body. The study aims to see how these combinations affect cancer and what side effects they might cause.
At a glance
What is this study about?
This study is an early-stage clinical trial for people who have advanced solid tumors. 'Solid tumors' are cancers that start in organs or tissues, like breast, lung, or bowel cancer, rather than blood cancers such as leukaemia. 'Advanced' means the cancer has either grown or spread to other parts of the body.
The main purpose of this research is to test combinations of new experimental drugs. The primary drug being studied is called Brigimadlin, and it's being tested with another new drug called Ezabenlimab. In some parts of the study, a third experimental drug might also be included. Because these are new treatments, the researchers need to find out what doses are safe and how the drugs work together in the body.
This is a 'Phase I' study, which is the very first step in testing new medicines in people. At this stage, the focus is on safety and finding the right dose, rather than on how well the treatment works against the cancer. Even so, researchers will also be looking to see if the drugs show any signs of affecting the cancer. Taking part helps doctors learn valuable information that could lead to new treatments in the future.
Key takeaways
- This study is testing new drug combinations for advanced solid tumors.
- It's an early-stage study focused on safety and finding the best dose.
- Adults aged 18 and over, with advanced solid tumors, are eligible.
- Participation involves regular hospital visits for medication and checks.
- Potential benefits include access to new treatments; risks include unknown side effects.
- You can withdraw from the study at any time.
Who may be eligible?
To be considered for this study, you must be an adult, aged 18 or older. There is no upper age limit, meaning people of all adult ages can potentially take part. All sexes are welcome to join, so both men and women can be considered.
The study is specifically for individuals who have been diagnosed with advanced solid tumors. This means your cancer has spread beyond its original site or has progressed despite previous treatments. The type of advanced solid tumor will be a key factor in deciding if this study is right for you, as different types of cancer may react differently to these experimental drugs.
There will be other, more detailed criteria that your doctor will check. These might include your general health, how well your organs are working (like your liver and kidneys), and what other medical conditions you have. These detailed checks are important to ensure your safety if you join the study.
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 an advanced solid tumor (cancer that has grown or spread)?
- Are you generally able to attend regular hospital visits?
- Are you willing to receive new experimental drug combinations?
What does participation involve?
If you decide to take part in this study, you would receive the experimental medicines at the hospital or clinic. Your participation would involve a series of visits for medical check-ups and assessments. These visits would allow the study doctors to monitor your health, how you are responding to the medication, and to look for any side effects.
Assessments would typically include blood tests, urine tests, and possibly scans (like CT scans) to see how the cancer is responding. There would be regular appointments with the study team who would ask about your general well-being and any symptoms you might be experiencing. The experimental drugs would be given to you according to a specific schedule decided by the study doctors.
After you finish taking the study medication, there would be a follow-up period during which the doctors would continue to monitor your health. The total duration of your participation, including treatment and follow-up, would be explained in full detail by the study team before you decide to join.
Potential risks and benefits
Locations (6)
- —UnverifiedNetherlands
- —UnverifiedGermany
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedHungary
- —UnverifiedBelgium
Common questions
What does 'advanced solid tumors' mean?
It means cancer that has grown or spread from where it started. This study is for various types of cancer that form solid growths, not blood cancers.
What is a 'Phase I' study?
It's the first stage of testing new medications in people. The main goals are to check if the treatment is safe, to find the right dose, and to see how it affects the body.
Will I definitely get the new drugs?
Yes, if you join this study, you will receive the experimental drug combinations. This study doesn't compare the drugs to a dummy pill (placebo) or standard treatment.
What does 'intervention' mean in this study?
Intervention refers to the experimental drugs you would receive as part of the study. In this case, it's specific combinations of Brigimadlin and Ezabenlimab, and sometimes a third drug.
Can I stop participating in the study if I change my mind?
Yes, absolutely. You have the right to leave the study at any time, for any reason, and it will not affect your ongoing medical care or relationship with your doctors.
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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