A First-in-Human Study to Evaluate the Safety and Anti-cancer Activity of the product FS120, which is an Antibody medication, to be administered alone or with Pembrolizumab in Subjects with Advanced Malignancies
This is a very early-stage study, called a 'first-in-human' trial, for a new cancer medicine. It's testing a drug named FS120, which is a type of antibody therapy. The main goals are to check if FS120 is safe for people with advanced cancers and to see if it shows any signs of fighting the cancer. Patients will either receive FS120 by itself or in combination with another established cancer drug called Pembrolizumab. This type of research helps doctors understand how new medicines work and if they could be helpful treatment options in the future.
At a glance
What is this study about?
This study is an early research project focusing on a new medicine called FS120. FS120 belongs to a group of treatments known as 'antibody medications.' These are designed to target specific things in the body, in this case, aiming to help fight cancer cells. The study is called 'first-in-human' because it's the very first time this particular medicine is being given to people. This means doctors are being extra careful to understand how it works and if it's safe.
The main aim of this trial is to learn about the safety of FS120. Doctors will be closely watching for any side effects and how the body reacts to the medicine. They also want to see if FS120 has any anti-cancer activity, meaning if it shows any signs of slowing down or shrinking tumours. Some participants in the study might receive FS120 on its own, while others might receive it alongside another cancer medicine called Pembrolizumab, which is already used to treat various cancers.
Studying new medicines like FS120 is a crucial step in finding better ways to treat advanced cancers. While this is an early study and not designed to be a definitive cure, the information gathered from participants is vital. It helps researchers decide if FS120 is promising enough to be studied in larger groups of people and potentially become a new treatment option in the future.
Key takeaways
- This is an early study testing a new cancer medicine (FS120) for the first time in people.
- The main goals are to check the medicine's safety and see if it shows any signs of fighting advanced cancers.
- Participants will receive FS120, either alone or with an existing cancer drug (Pembrolizumab).
- It's open to adults aged 18 and older with advanced malignancies.
- Participating will involve regular hospital visits for treatments and checks.
- You can stop participating at any time.
Who may be eligible?
To join this study, you must be an adult aged 18 or older. There is no upper age limit, so people of all adult ages can be considered. The study is open to both men and women.
The main requirement is that you have a type of cancer that is considered 'advanced.' This generally means the cancer has spread or is difficult to treat with standard therapies. The medical team will check specific details of your cancer and your overall health to make sure this study is suitable for you.
It’s important to remember that even if you meet these general points, there will be other specific medical checks and criteria that the study doctors need to go through to determine if you can safely participate. This is to ensure the study is safe and appropriate for everyone involved.
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?
- Have you been diagnosed with an advanced cancer?
- Are you able to regularly attend hospital for appointments and treatments?
- Are you willing to potentially receive a new, untested medicine?
- Are you able to understand and sign consent forms?
What does participation involve?
Taking part in this study would involve regular visits to the hospital or clinic. During these visits, you would have medical check-ups, blood tests, and scans (like CT or MRI) to see how the treatment is affecting you and your cancer. The new medicine, FS120, would be given to you as an infusion, likely through a drip into your arm.
If you are in the group receiving Pembrolizumab, that would also be given as an infusion. The study team will explain the schedule for these treatments and tests, which will vary. You would be closely monitored for any side effects, and the doctors and nurses would be available to answer your questions and support you throughout. The total length of your participation would depend on how you respond to the treatment and what the study doctors decide is best for you, but it would involve regular follow-up for a period of time.
Potential risks and benefits
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Common questions
What does 'first-in-human' mean?
It means this is the very first time this new medicine, FS120, is being given to people. Researchers are carefully checking its safety and how it works.
What is an 'antibody medication'?
It's a type of medicine that uses the body's natural defence system (antibodies) to specifically target and fight things like cancer cells.
Will I definitely get the new medicine?
Yes, if you join this study, you will receive FS120, either on its own or together with another cancer drug called Pembrolizumab.
What kind of cancer is this for?
This study is for people who have advanced types of cancer, meaning it has spread or is difficult to treat with standard methods.
Can I stop participating if I want to?
Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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