This is clinical study to test, for the first time in people, the safety (any good or bad effects), how long the drug can stay in the body and if it can control the disease of people diagnosed with advanced cancer that has not responded to treatment, has returned after it has been treated, or cannot be treated by surgery, drugs, or any other known treatments.
This is an early-stage clinical trial looking into a new medication for advanced cancers. These are cancers that have either not gotten better with usual treatments, have returned after being treated, or cannot be treated effectively by surgery or other available therapies. The study is being conducted in people for the very first time. Researchers want to understand if the drug is safe, what side effects it might have, how it moves through and leaves the body, and if it shows any signs of shrinking or controlling the cancer. This kind of study is crucial for learning about potential new treatments for difficult-to-treat cancers.
At a glance
What is this study about?
This clinical trial is an important early step in testing a brand new medication for certain advanced cancers. We often call this a 'Phase 1' study, which means it's one of the first times this drug is being given to people. The main purpose at this stage isn't to prove the drug cures cancer, but to gather essential information.
The researchers are focusing on a few key things: Firstly, they want to understand if the drug is safe. They will carefully monitor for any side effects, both good and bad. Secondly, they'll learn how the drug acts in the body, such as how long it stays there after being taken. Thirdly, they'll be looking for early signs that the drug might be helping to control the cancer, such as slowing its growth or making it shrink.
This study specifically includes people with advanced cancers that have become difficult to treat. This might mean the cancer hasn't responded to previous treatments, has come back after treatment, or isn't suitable for surgery or other standard therapies. The trial is looking at different types of cancer, including certain advanced solid tumours and particular types of lymphoma, which is a blood cancer. By participating, patients are helping scientists learn more about this new drug and whether it could be a future treatment option.
Key takeaways
- Tests a new drug for advanced cancers in people for the first time.
- Focuses on safety, how the body handles the drug, and early signs of effectiveness.
- For cancers that haven't responded to other treatments, have returned, or are untreatable.
- Includes various advanced solid tumours and certain lymphomas.
- Participation involves regular monitoring and assessments.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. Both men and women can participate. The study is looking for people who have advanced cancer that has not responded well to standard treatments, has returned after treatment, or cannot be treated effectively with current therapies.
Specifically, the study is divided into different groups. Some groups are for people with advanced solid tumours, which are cancers that form a lump or mass. Other groups are for people with certain types of lymphoma, which is a cancer of the immune system called non-Hodgkin's lymphoma, that has come back or is hard to treat. There's also a specific group for advanced basal cell carcinoma, a type of skin cancer, and another for a particular kind of lymphoma called diffuse large B-cell lymphoma.
It's important to remember that these are just general guidelines. The medical team will have a full list of detailed requirements to make sure the study is right and safe for you. They will review your medical history and test results carefully to see if you meet all the criteria.
- Are you 18 years old or older?
- Do you have a type of advanced cancer that hasn't responded to previous treatments, has returned, or cannot be treated by surgery/other drugs?
- Are you willing to attend regular appointments for monitoring and treatment?
- Are you able to understand and agree to the study procedures (informed consent)?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
As this is an early-stage study, taking part would involve regular visits to the clinic for assessments. These will include blood tests, physical examinations, and possibly scans to monitor your health and how the drug is affecting your cancer. You will be given the study medication as prescribed by the research team. The exact number of visits and tests will be detailed by the study doctors. There will also be follow-up appointments after you stop taking the drug to ensure your safety and monitor any lasting effects. The total duration of your participation will depend on how you respond to the treatment and the study plan, but it generally involves regular monitoring over a period of time.
Potential risks and benefits
Locations (2)
- —Italy
- —Spain
Common questions
What does 'advanced cancer' mean in this study?
It means the cancer has spread or grown significantly, or it hasn't responded well to standard treatments, has returned, or isn't treatable by other means.
What is the purpose of a 'Phase 1' study like this?
The main goal is to check if the new drug is safe, what side effects it might cause, and how the body handles it. We also look for early signs that it might help control the cancer.
Will I definitely get the new drug?
Yes, in this type of study, all participants who are accepted will receive the new investigational drug.
How long would I need to be in the study?
The duration can vary depending on how you respond and the study plan. The study team will explain the expected time commitment for visits and follow-up.
Can I stop participating in the study if I change my mind?
Yes, you have the right to withdraw from the study at any time, 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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