A dose-escalation and expansion study of the safety and pharmacokinetics of XB002 as single-agent and combination therapy in subjects with inoperable locally advanced or metastatic solid tumors
This research study is for people living with advanced solid cancers that either cannot be removed by surgery, or where other treatments haven't worked or caused too many side effects. The main goal is to understand a new medicine called XB002. Scientists want to see how safe it is and how it behaves in the body, both when given on its own and when combined with other existing cancer drugs like nivolumab or bevacizumab. The study will check XB002 in up to ten different types of cancer when given alone, and in specific lung, head and neck, and oesophageal cancers when given with nivolumab, or ovarian cancer when given with bevacizumab. It's an early-stage study, meaning it's one of the first times this medicine is being tested in people.
At a glance
What is this study about?
This study is a Phase 1 clinical trial, which means it's an early-stage study designed to understand a new medicine called XB002. Imagine it as a first look at how a new car performs – but for medicine. The main goals are to find out if XB002 is safe for people to take, what side effects it might have, and how it moves through the body. This helps doctors learn the right dose to give.
The study is for people with advanced solid tumours. A 'solid tumour' is a lump of abnormal cells, like those found in breast, lung, or bowel cancer, as opposed to blood cancers. 'Advanced' means the cancer has spread or grown significantly. This study is specifically for individuals where surgery isn't an option, or when other commonly used treatments are no longer effective or cause too many difficult side effects.
XB002 will be tested in two ways. Firstly, it will be given on its own to people with up to ten different types of advanced cancers. Secondly, it will be tested in combination with other established cancer drugs. For example, it will be combined with nivolumab for certain lung, head and neck, and oesophageal cancers, and with bevacizumab for a type of ovarian cancer. By testing XB002 alone and with other medicines, researchers hope to see if it could offer new treatment options for people living with these challenging cancers.
Key takeaways
- This study evaluates a new medicine (XB002) for advanced solid cancers.
- It aims to find out if XB002 is safe and how it works in the body.
- XB002 is tested alone and with other established cancer drugs.
- It's for people whose cancers can't be surgically removed or current treatments aren't working.
- Participation involves regular clinic visits, blood tests, and scans.
- You can withdraw from the study at any time.
Who may be eligible?
To be part of this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
Critically, the study is looking for people who have solid tumours that are advanced, meaning they cannot be surgically removed or have spread. This also applies if the usual life-prolonging treatments haven't worked for you, or if the side effects from those treatments were too difficult to manage.
There might be other specific health requirements or conditions that would mean you can or cannot join the study, but these would be discussed in detail by the study team and your doctor.
- Are you 18 years old or older?
- Do you have a solid tumour that is advanced?
- Can your cancer not be fully removed by surgery?
- Have your current cancer treatments stopped working, or caused difficult side effects?
- Are you willing to attend regular hospital visits for tests and monitoring?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will be given the new medicine, XB002, either on its own or together with another cancer drug. The study team will carefully monitor you throughout your participation. This will involve regular visits to the clinic, where you'll have various assessments. These assessments typically include physical examinations, blood tests, and scans to check how the medicine is affecting your body and your cancer. The frequency and duration of these visits will vary depending on your specific treatment plan and how you are responding. You will have regular checks as long as you are receiving the study medication, and then follow-up appointments after you stop treatment to monitor your health.
Potential risks and benefits
Locations (5)
- —Netherlands
- —Spain
- —Belgium
- —France
- —Italy
Common questions
What is a 'solid tumour'?
A solid tumour is a growth of abnormal cells that forms a lump, like those found in cancers of the breast, lung, or bowel, unlike blood cancers like leukaemia.
What does 'advanced cancer' mean?
Advanced cancer means the cancer has spread from where it started (metastasised) or has grown significantly, making it difficult to treat with local methods like surgery alone.
Why is this called a 'Phase 1' study?
Phase 1 is the first stage of testing a new medicine in people. The main goal is to check its safety, understand how it behaves in the body, and find the right dose, rather than primarily seeing if it cures the disease.
Will I receive an old drug or a new drug?
You will receive the new investigational drug, XB002, either by itself or combined with an existing, approved cancer treatment like nivolumab or bevacizumab.
Can I stop participating if I want to?
Yes, absolutely. You can choose to leave the study at any point, for any reason, and it will not affect your ongoing 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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