A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) and BI 765179 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Cancer
This research study is for adults with advanced cancer, including a specific type of head and neck cancer. It has two main parts. Part 1 aims to find the safest and highest dose of a new medicine, BI 765179, when given by itself or with another drug called ezabenlimab. This part is for people with various advanced solid tumours. Part 2 focuses on people with advanced head and neck cancer, checking if BI 765179 combined with pembrolizumab can be helpful. Both BI 765179 and ezabenlimab are new antibody treatments that could potentially help your body's immune system fight cancer. Participants will receive their treatment through an infusion into a vein every three weeks. Doctors will closely monitor participants' health throughout the study.
At a glance
What is this study about?
This study is a research project looking into potential new treatments for advanced cancer. It focuses on a new drug called BI 765179. We want to understand how safe this new drug is and whether it can help people with different types of advanced cancer, including those with advanced head and neck cancer.
The study is divided into two main sections. In the first part, we're trying to figure out the right amount of BI 765179 that people with solid tumours can take without too many side effects. This new drug might be given on its own or together with another medicine called ezabenlimab. Both of these are 'antibody' medicines, which means they are designed to work with your body's own defence system (your immune system) to fight against cancer cells.
The second part of the study focuses specifically on people with advanced head and neck cancer. Here, we're testing if BI 765179, when given alongside a well-known cancer drug called pembrolizumab, can be effective. Pembrolizumab is also an antibody medicine that helps the immune system. This study is important because it's the first time BI 765179 will be given to people, and it could lead to new treatment options for those with advanced cancers.
Key takeaways
- This study is testing a new cancer drug called BI 765179.
- It's for adults with advanced solid tumours, including head and neck cancer.
- The new drug will be given alone or combined with other immune-boosting medicines.
- Treatment is given as an infusion every three weeks.
- Participants will be closely monitored for health and side effects.
- It's the first time BI 765179 is used in people, so potential benefits and risks are being carefully assessed.
Who may be eligible?
This study is for adults aged 18 or over who have advanced cancer that has either not responded to standard treatments or for which standard treatments aren't suitable. Importantly, your cancer must be a type that is expected to show high levels of a specific protein called Fibroblast activation protein (FAP). This includes various cancers like lung, stomach, bowel, bladder, and certain head and neck cancers, among others.
You would need to be well enough to take part, meaning you can mostly look after yourself. We would also need to check your liver, kidney, and bone marrow are working adequately. For women who could become pregnant and men who could father a child, it's important to be willing and able to use reliable contraception throughout the study and for at least six months afterwards. If you have cancer that has spread to the brain, you might still be able to join if these brain tumours have been treated effectively and are stable.
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 hasn't responded to standard treatments or for which standard treatments aren't suitable?
- Do you have one of the listed cancer types that is expected to show high levels of the FAP protein?
- Are you generally well enough to manage your daily activities?
- Are you willing and able to use effective birth control if applicable?
What does participation involve?
If you join this study, the treatment will be given to you as an infusion (drip) into a vein, typically every three weeks. Depending on which part of the study you are in, you would receive BI 765179 either by itself, with ezabenlimab, or with pembrolizumab. In some parts of the study, people receive different doses of the medication.
You will have regular check-ups with the study doctors and nurses to monitor your health, how you are responding to the treatment, and if you experience any side effects. You can stay in the study for up to two years, as long as the treatment is helping you and you are tolerating it well. You are free to withdraw from the study at any time.
Potential risks and benefits
Locations (48)
- University of ArizonaVerified postcodeTucson, United States
- Beverly Hills Cancer CenterVerified postcodeBeverly Hills, United States
- The University of North Carolina at Chapel HillVerified postcodeChapel Hill, United States
- Avera Cancer InstituteVerified postcodeSioux Falls, United States
- NEXT Oncology-San Antonio-65273Verified postcodeSan Antonio, United States
- Border Cancer HospitalVerified postcodeAlbury, Australia
- Kinghorn Cancer CentreVerified postcodeDarlinghurst, Australia
- Townsville HospitalVerified postcodeDouglas, Australia
- Austin HospitalVerified postcodeHeidelberg, Australia
- Cliniques Universitaires Saint-LucVerified postcodeBrussels, Belgium
- Edegem - UNIV UZ AntwerpenVerified postcodeEdegem, Belgium
- AZ GroeningeVerified postcodeKortrijk, Belgium
Common questions
What is advanced cancer?
Advanced cancer means the cancer has spread from where it started to other parts of the body, or it's a type that can't be fully removed with surgery.
What are 'solid tumours'?
'Solid tumours' are cancers that form a lump or mass of cells, unlike blood cancers like leukaemia.
What are BI 765179, Ezabenlimab, and Pembrolizumab?
These are all types of medicine called antibodies. They are designed to help your body's immune system recognise and fight cancer cells.
How will I receive the treatment?
The treatment will be given to you through a drip into a vein, which is called an infusion.
How long will I be in the study?
You could be in the study for up to two years, as long as the treatment is helping you and you are not having too many side effects.
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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