A dose escalation and expansion study of XB010 as a single agent and combination therapy in subjects with locally advanced or metastatic solid tumors
This clinical trial is studying an experimental medicine called XB010 for adults with advanced solid tumours. An advanced or metastatic tumour means cancer that has grown deeply into nearby tissues or spread to other parts of the body. Because this is a Phase 1 study, it is one of the first times XB010 is being given to people. The main purpose is to check how safe the drug is, find the safest and most effective dose, and watch for any side effects. Researchers will test XB010 on its own and also in combination with other treatments. Participants will have regular hospital visits for health checks, blood tests, and scans to see how their body and tumour respond. The findings will help doctors decide whether XB010 should be developed into a new cancer treatment in the future.
At a glance
What is this study about?
Solid tumours are lumps of cancer cells that form in body organs such as the lungs, bowel, or breasts. Sometimes cancer spreads from where it started to other areas of the body, which doctors call advanced or metastatic cancer. When this happens, common treatments may stop working as well as they once did. Because of this, scientists are working hard to discover and test new medicines that can target cancer in different ways.
This trial is looking at an experimental drug called XB010. It is a 'Phase 1' study, which means it is in the earliest phase of testing in humans. The main goal of this stage is not yet to prove the drug cures cancer, but rather to understand how the human body processes it. The study team wants to find out what dose is safe, what unwanted side effects it might cause, and whether there are early signs that it can help keep tumours under control.
The study has two steps. In the first step, called dose escalation, small groups of patients receive slowly increasing doses so doctors can find the safest amount to give. In the second step, called dose expansion, more people receive that chosen dose so doctors can study how well it works, either as a single treatment or combined with other cancer drugs.
Key takeaways
- Tests a new medicine called XB010 for advanced solid tumours.
- This is an early-stage study focused on safety, side effects, and finding the right dose.
- Open to adults aged 18 and older whose cancer has spread or returned after standard care.
- Involves regular hospital visits for treatment, blood tests, and scans.
- Participation is entirely voluntary, and you can withdraw at any time.
Who may be eligible?
This study is open to adults aged 18 and over who have been diagnosed with an advanced or metastatic solid tumour. It is designed for people whose cancer cannot be removed by surgery or has continued to grow despite trying standard NHS treatments.
To take part, you will need to be well enough to carry out everyday activities, such as light housework or walking. You will also need to have reasonably healthy organ function, such as good kidney, liver, and heart health, to make sure your body can safely handle the new medicine.
You might not be able to join if you are pregnant, breastfeeding, or have other serious, uncontrolled medical conditions that could make taking part unsafe. Your cancer specialist can review your medical history to see if this study is an option 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.
- I am 18 years of age or older.
- I have been diagnosed with an advanced or metastatic solid tumour.
- My cancer has continued to grow after trying standard treatments, or no standard treatments are suitable.
- I am well enough to walk around and manage my own personal care.
- I am able to attend regular hospital appointments for check-ups and scans.
What does participation involve?
If you take part, you will need to visit the hospital clinic regularly. During these visits, you will receive the study medicine, which may be given as a drip into a vein or taken as tablets. You will have regular checks to monitor your safety, including blood tests, urine tests, heart traces (ECGs), and physical exams. You will also have periodic imaging scans, such as CT or MRI scans, to see if the treatment is affecting your tumour. The study will last for as long as the treatment continues to help you without causing severe side effects, followed by a check-up period after treatment finishes to monitor your long-term health.
Potential risks and benefits
Locations (4)
- —UnverifiedItaly
- —UnverifiedNetherlands
- —UnverifiedFrance
- —UnverifiedSpain
Common questions
What is a Phase 1 clinical trial?
A Phase 1 trial is the first step in testing a new medicine in people. Its main goal is to test safety, find the right dose, and check for side effects.
Will I receive a dummy drug (placebo)?
In early Phase 1 cancer studies like this one, placebos are rarely used. You can expect to receive the active study medicine, XB010, either alone or with another cancer treatment.
Do I have to pay to take part?
No. The study treatment and tests are provided free of charge, and some trials may help cover travel expenses to the hospital.
Can I carry on with my daily activities?
Most people can continue their normal routine, but it depends on how you feel and how often you need to attend hospital appointments.
What happens if I decide to leave the study?
You are free to stop participating at any time. Your doctors will support your decision and discuss other available treatment options with you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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