A Modular, Open Label, Dose Finding Phase 1/2 Clinical Trial in Patients with Solid Tumours to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PTT-4256 (RAISIC-1: Relief of Acidic Immune Suppression In Cancer)
This research study is called RAISIC-1 and is looking into a new medicine called PTT-4256 for people who have solid tumours, which are lumps of cancer cells found in different parts of the body. The main aim is to understand if PTT-4256 is safe and how well people tolerate it. We also want to see how the body handles the medicine and check for any early signs that it might be effective against cancer. Some parts of the study will also look at how it works when given alongside another cancer medicine called OPDIVO. This is an early-stage study, meaning it's one of the first times this new medicine is being tested in people. It will help us learn more about its potential to treat cancer in the future.
At a glance
What is this study about?
This study, known as RAISIC-1, is an important step in developing new treatments for people with solid tumours. Solid tumours are a type of cancer that forms a mass, unlike blood cancers. The new medicine being tested is called PTT-4256. It's designed to help the body's immune system fight cancer by addressing something called 'acidic immune suppression' – think of it as making the cancer environment less friendly for the cancer and more friendly for your immune cells.
The main purpose of this study is to carefully check the safety of PTT-4256. This means keeping a close eye on any side effects that people might experience. We also want to understand how the body absorbs, breaks down, and gets rid of the medicine. In some parts of the study, PTT-4256 will be given on its own, and in other parts, it will be given together with another cancer medicine, OPDIVO, which is already used to treat certain cancers. This helps researchers see if the new medicine works well alone or in combination.
Because this is an early-stage study (called Phase 1 and Phase 2), it's the first time this specific medicine is being tested in people. This means we'll start with small doses and gradually increase them to find the safest and most effective amount. We'll also be looking for early signs that the medicine might be shrinking tumours or stopping their growth, as well as checking how long people live after starting the treatment. This information is crucial for deciding if PTT-4256 should be studied further in larger groups of people.
Key takeaways
- This study is testing a new cancer medicine called PTT-4256.
- It's for adults with solid tumours.
- The main goals are to check safety and how the medicine works in the body.
- It will also look for early signs that the medicine might shrink tumours.
- Sometimes, PTT-4256 will be given with another medicine, OPDIVO.
- This is an early-stage study, gathering important initial information.
Who may be eligible?
To be able to join this study, you need to be at least 18 years old – there's no upper age limit, meaning people of all adult ages can potentially take part. The study is open to both men and women.
The study is specifically for people who have been diagnosed with solid tumours. This means your cancer must form a mass rather than being a blood cancer.
It's important to remember that these are just general guidelines. There will be other specific health requirements that your doctor will need to check to see if this study is suitable for you. They will review your medical history and current health carefully.
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 solid tumours (not blood cancer)?
- Are you able to attend regular hospital visits for check-ups and tests?
- Are you willing to have scans and blood tests as part of the study?
- Are you open to the possibility of receiving an experimental new medicine?
What does participation involve?
If you decide to take part in this study, you'll be given the new medicine, PTT-4256. You might also receive OPDIVO, another medicine, depending on which part of the study you're in. During the study, you'll have regular hospital visits for assessments. This will involve physical examinations, blood tests to check your general health and how the medicine is working in your body, and scans (like CT or MRI scans) to see if your tumour is changing.
Researchers will closely monitor you for any side effects or changes in your health. After your active treatment period finishes, there will be follow-up calls every three months to check on your health and overall well-being. The total length of time you'll be actively treated and monitored at the hospital will vary, but the study team will explain all the details before you make a decision. The follow-up calls will continue for a longer period to understand the long-term effects of the treatment.
Potential risks and benefits
Locations (2)
- —UnverifiedFrance
- —UnverifiedSpain
Common questions
What kind of cancers is this study looking at?
This study is for people who have solid tumours, which are cancers that form a mass in the body.
What is PTT-4256?
PTT-4256 is a new experimental medicine being tested to see if it can help the body's immune system fight cancer.
Will I have to pay to be in the study?
No, you will not have to pay for the study medicine or related tests and appointments.
What does 'Phase 1/2' mean?
It means this is an early study. Phase 1 checks if the medicine is safe, and Phase 2 looks for early signs of how well it works.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time without needing to give a reason, and it won't affect 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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