A First In Human Phase I Trial Evaluating safety, tolErability and ResponSe of [211At]At-Girentuximab (ATO-101™) in PatiEnts with Non-Muscle-InVasive BladdER CANCEr Refractory to Standard Treatment (PERSEVERANCE EU)
This study, called PERSEVERANCE EU, is looking for people with a type of bladder cancer that hasn't improved with standard treatments. The cancer is called 'non-muscle-invasive bladder cancer' (NMIBC), meaning it's in the bladder's lining and hasn't spread deeper. This is a very early stage trial, a 'first-in-human' study, which means it's the first time this new medicine, called [211At]At-Girentuximab, will be given to people. The main goals are to carefully check if the new medicine is safe, how well people tolerate it (meaning, how they feel when they take it), and to see if there are any early signs that it might be effective against the cancer. Since it's an early study, we're mainly focused on safety.
At a glance
What is this study about?
This study is about a type of bladder cancer that has not yet grown into the deeper layers of the bladder wall – doctors call this 'non-muscle-invasive bladder cancer' (NMIBC). For some people, the usual treatments for this type of cancer don't work well, or the cancer keeps coming back. For these patients, finding new treatment options is really important.
This trial is looking at a new medicine called [211At]At-Girentuximab. It's a 'first-in-human' study, which means it's the very first time this specific medicine will be given to people. Because it's so new, the main aim is to carefully check if it's safe and if people can tolerate it without too many problems. This is done by giving small doses at first and slowly increasing them while watching very closely for any side effects.
Even though the main focus is on safety, researchers will also be looking for any early hints that the medicine might be helping to treat the cancer. This information will help them decide if this new medicine should be studied further in larger groups of people. Every new treatment starts with these careful steps to ensure safety first.
Key takeaways
- This study is for a new medicine for non-muscle-invasive bladder cancer.
- It's for people whose cancer hasn't responded to usual treatments.
- It's the first time this medicine is being given to humans, focusing on safety.
- You must be 18 years or older to participate.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. The study welcomes both men and women.
The most important health requirement is that you must have non-muscle-invasive bladder cancer (NMIBC). This means the cancer is in the lining of your bladder and hasn't spread into the deeper muscle layer. Crucially, your cancer must be 'refractory,' which means it hasn't responded to standard treatments, or it keeps coming back even after these treatments.
There will be other detailed health checks to make sure your body is healthy enough for the study medicine and that it's safe for you to take part. For example, your kidney and liver function will be checked, and you'll need to meet specific blood test results. The study doctor will explain all these in detail.
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?
- Do you have non-muscle-invasive bladder cancer?
- Has your bladder cancer not responded to standard treatments?
- Are you able to attend regular hospital visits for monitoring?
What does participation involve?
If you decide to take part, you'll first have a full health check-up to make sure the study is right for you. This will involve blood tests, urine tests, scans, and a review of your medical history.
Once enrolled, you will receive the study medicine, [211At]At-Girentuximab, which will likely be given directly into a vein. You'll have regular hospital visits, especially at the beginning, so the study team can closely monitor your health, how you're feeling, and how your body is reacting to the medicine. These visits will involve physical examinations, blood and urine tests, and potentially more scans to check your cancer and overall health.
The total duration of your participation will vary. The treatment period involves receiving the medicine and close monitoring, followed by a period of follow-up visits to track your long-term health and any effects of the treatment. The research team will explain the full schedule of visits and procedures in detail.
Potential risks and benefits
Locations (1)
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Common questions
What is 'non-muscle-invasive bladder cancer'?
It's a type of bladder cancer that has only grown into the lining of the bladder, not into the deeper muscle wall.
What does 'refractory to standard treatment' mean?
It means your bladder cancer has not gotten better with the usual treatments, or it has come back despite those treatments.
Is this medicine new?
Yes, this is the very first time this specific medicine, [211At]At-Girentuximab, is being tested in people. It's a very early-stage trial.
What are the main goals of this study?
The main goals are to see if the new medicine is safe, how well people tolerate it, and if there are any early signs that it might help treat the cancer.
Can I stop participating in the study if I want to?
Yes, you can choose to leave the study at any time, for any reason, and it won't affect your regular 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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