An phase I study of BI 765063 (a monoclonal antibody) as single agent and in combination with BI 754091 (a PD-1) to characterize safety, pharmacokinetics, pharmacodynamics and preliminary efficacy in patients with advanced solid tumour
This research study is for adults with advanced cancers. We are testing two new medicines, one called BI 765063 and another called BI 754091. Sometimes these medicines will be given together, and sometimes BI 765063 will be given on its own. The main goals are to find out if these new medicines are safe for people to take, how they move through the body, and what effects they have. We will also be looking to see if they show any signs of helping to shrink tumours. This is an early phase study, meaning it's one of the first times these medicines are being given to people.
At a glance
What is this study about?
This clinical trial is designed for people who have advanced solid tumours. "Advanced" means that the cancer has grown and spread from where it started. "Solid tumour" refers to cancers that form a lump, like breast cancer or lung cancer, rather than blood cancers.
The main purpose of this study is to explore two new medicines, BI 765063 and BI 754091. BI 765063 is a type of medicine called a 'monoclonal antibody', which is a laboratory-made protein that can target specific things in your body. BI 754091 is also a similar type of medicine that works on the immune system, often called an 'immunotherapy'. Researchers want to understand several things: first, are these medicines safe for people? Second, how does the body process these medicines? Third, what effects do they have on the body? Finally, they are looking for early signs that these medicines might be effective in helping to treat the cancer.
This is an "early phase" study, specifically a Phase I and Phase II study. This means it's one of the first times these particular medicines are being given to humans. Early phase studies are crucial for gathering essential information about new treatments before they can be tested in larger groups of people. If the results from this study are promising, it could lead to further research into these medicines for cancer treatment.
Key takeaways
- This study is for adults with advanced solid tumours.
- It's testing two new medicines (BI 765063 and BI 754091) for safety and early signs of effectiveness.
- This is an early-stage clinical trial (Phase I/II).
- Participation involves regular hospital visits, medicines, and monitoring.
- You can withdraw from the study at any time.
- You should discuss it with your doctor to see if it's right for you.
Who may be eligible?
This study is looking for adults aged 18 or over. The study includes both men and women.
To be considered for this study, you must have an advanced solid tumour. This means your cancer has spread beyond its original location. The study isn't specific to one type of cancer, so various types of advanced solid tumours are being considered.
There will be other, more detailed reasons why someone might be suitable or not suitable for the study. For example, your general health, other medical conditions you might have, or previous treatments for your cancer would all be carefully checked by the study doctors. These checks are to ensure the study is as safe as possible for you.
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 an advanced solid tumour (cancer that has spread)?
- Are you able to travel to study appointments?
- Are you willing to follow the study schedule?
- Have you discussed this trial with your main cancer doctor?
What does participation involve?
If you decide to take part in this study, you will have regular visits to the hospital or clinic. These visits will involve blood tests, physical examinations, and other tests like scans to monitor your health and how your body is reacting to the medicine. The study medicines (BI 765063 or BI 754091, or both) will be given to you during these visits.
The research team will closely monitor you throughout the study. After you finish receiving the study medicines, you will have follow-up appointments. These might involve further checks and tests to see how you are doing over time. The total length of your participation will depend on how you respond to the treatment and other factors, and the study team will explain this in detail.
Potential risks and benefits
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Common questions
What does 'advanced solid tumour' mean?
It means your cancer started as a lump and has now grown or spread from where it first began.
What are 'Phase I and Phase II' studies?
These are early parts of drug testing. Phase I checks safety, and Phase II looks for signs that a drug might work and continues to check safety.
What kind of medicines are BI 765063 and BI 754091?
They are new, specially designed antibodies. One might be an immunotherapy, which helps your body's immune system fight cancer.
Will I definitely get the new medicine?
Yes, everyone in this study will receive the new medicines. Some will receive one, and some will receive both together.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason. Your decision will not 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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