
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
This study is looking at a drug called T3P-Y058-739 (T3P) for solid cancers.
A solid cancer is any cancer apart from a blood cancer such as leukaemia, lymphoma and myeloma.
T3P consists of . It is a live bacterial therapy. In this trial the
of T3P have been changed in 2 ways. Some of the genes have been removed so that it is weaker. This means that it is less likely to cause symptoms that bacteria would normally cause.
And some genes have been added to help stimulate the . These changes also help T3P grow in the cancer. T3P works by stimulating the immune system to recognise and attack cancer cells.
show that T3P might help people with cancer. This study is the first time that people will have T3P.
There are a number of parts in this study. The first part is to find the best dose of T3P to give directly into the cancer. This is the dose that helps the most and has the fewest side effects.
This is the only part open at the moment. Researchers need to know what the best dose of T3P is to give before they can go on to the next parts of the study.
The aim of this part of the study is to find out what is the best dose of T3P to give directly into the cancer.
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this study if all of the following apply. You:
Who can’t take part
Cancer related
You cannot join this study if any of these apply. You:
Medical conditions
You cannot join this study if any of these apply. You:
Other
You cannot join this study if any of these apply. You:
This is an international phase 1/2 study.
There are a number of parts to the study. Only Part A is now open. They need about 20 people to join this part with about 10 people in the UK.
The first few people have a low dose of T3P. If they don’t have any bad side effects the next few have a higher dose. And so on until the team find the best dose of T3P to give.
You have T3P as an injection into the cancer. You have the injection twice a week for 4 weeks. After this you might be able to have T3P once every 2 weeks. You can have treatment for up to 6 months.
Before having the T3P injection you have desferrioxamine. T3P needs iron to survive and grow. Desferrioxamine binds to iron in the body so that the T3P can get it. You have desferrioxamine as an injection into the muscle about 1 hour before the T3P injection.
You start antibiotics up to 2 weeks after the last injection of T3P. Your doctor will tell you more about this.
Samples for research
The team take extra blood samples during the study. Where possible they take these at the same time as your routine blood tests.
They use these samples to find out what happens to T3P in the body and how it affects the body.
The team will ask for samples of tissue () of your cancer. Your doctor will tell you about when they want to take the samples and how they take them.
You don’t have to agree to have these tissue samples taken.
You see the doctor to have tests before taking part. These include:
You might also have a scan of your brain or a bone scan if your doctor thinks your cancer might have spread there.
You see the doctor at regular times while having treatment. This is for blood tests and to see how you are.
After treatment you see the doctor every 4 weeks for 3 months.
The study team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
When going to the hospital or to the doctor you should tell the healthcare staff that you have had a live bacterial therapy. |
This is the first time T3P is used in people. T3P uses a bacteria that has well known side effects. We also know the side effects of other bacterial treatments used for cancer. And T3P has been well researched in laboratory studies. Based on this information the side effects expected include:
There is a small chance that T3P might get into your blood. If this happens you might have the following side effects:
Other important side effects might be:
You might get an infection in your central line or implanted device such as a portacath if you have one of these.
The side effects of desferrioxamine include:
Your doctor will tell you about the possible side effects of the treatments before you agree to join the study.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Kevin Harrington
T3 Pharmaceuticals AG
IQVA BIOTECH
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”