A study of T3P-Y058-739 for cancer (T3P)

Cancer type:

All cancer types

Status:

Open

Phase:

Phase 1/2

This study is looking at a drug called T3P-Y058-739 (T3P) for advanced Open a glossary item solid cancers.

A solid cancer is any cancer apart from a blood cancer such as leukaemia, lymphoma and myeloma.

More about this trial

T3P consists of bacteria Open a glossary item . It is a live bacterial therapy. In this trial the genes 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 immune system Open a glossary item . These changes also help T3P grow in the cancer. T3P works by stimulating the immune system to recognise and attack cancer cells.

Laboratory studies Open a glossary item 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.

Who can enter

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:

have a solid cancer that has spread and cannot be removed by surgery
have a cancer for which there is no treatment with the aim to cure available or there is no treatment that is suitable for you. Your doctor will talk to you about this.
have an area of cancer that the doctor can see or can see on an ultrasound and T3P can be directly injected into the cancer
have satisfactory blood test results
are up and about, can look after yourself but might not be able to do heavy physical work (performance status 0 or 1)
are willing to use contraception during the treatment and for a period of time after. This is if there is a chance you or your partner could become pregnant.
are at least 18 years old

Who can’t take part

Cancer related
You cannot join this study if any of these apply. You:

have cancer spread to the brain or spinal cord. This is unless it has been treated and there is no sign of any cancer remaining, for example the cancer spread was completely removed by surgery. And there is no sign that the cancer has come back.
have cancer near an important area of the body such as a large blood vessel that could be damaged or inflamed after the TP3 injections. Your doctor will know which areas these are.
have ongoing moderate to severe side effects from previous treatments. This is apart from hair loss.
have chemotherapy, hormone therapy or an immunotherapy around 4 weeks of starting study treatment. For the chemotherapy drugs mitomycin C and nitrosourea it is around 6 weeks.
have radiotherapy around 4 weeks of starting study treatment. This is apart from radiotherapy to relieve symptoms (palliative radiotherapy).
have had a bone marrow transplant from a donor (allogenic), a stem cell transplant or a targeted drug called a CD-20 protein antibody. Your doctor will know if you have had one of these.
have had a previous cancer that could be confused with the one you have now or could cause confusion in the trial. Your doctor will know about this.

Medical conditions
You cannot join this study if any of these apply. You:

have had an infection with a bacteria that is similar to the one used in T3P within the past 3 months. Or such bacteria are identified in the poo (stool) sample you give when you agree to join the study.
are taking medication that affects the immune system . This is apart from inhalers and steroids to replace what the body would have made.
have HIV, hepatitis B, hepatitis C or any other major infection such as pneumonia in the past 4 weeks. You might be able to join if your infection was more than 4 weeks ago and you are fully recovered.
have had antibiotics recently that could affect how well TP3 works. Your doctor will know what these antibiotics are.
have heart problems that could affect you taking part
have had a joint replacement or heart valve replacement or any other type of artificial replacement that cannot be removed from your body
have an autoimmune disease that could affect you taking part. Your doctor will know which ones these are.
have too much or too little iron in the body or you need special treatment to reduce the iron levels in the body
have a problem with bleeding. This is unless the area of cancer is just below the skin and is at a low risk of bleeding.
are taking medication to thin your blood such as warfarin. This is unless it is a low dose. Your doctor will know what dose is acceptable.
have any other medical condition, mental health problem or social situation that could affect you taking part

Other
You cannot join this study if any of these apply. You:

are allergic or sensitive to T3P, desferrioxamine or any of their ingredients
are allergic or sensitive to chloramphenicol or all of the following cotrimoxazole, doxycycline, ceftriaxone and cefotaxime
are pregnant or breastfeeding

Trial design

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 (biopsies Open a glossary item ) 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.

Hospital visits

You see the doctor to have tests before taking part. These include:

a physical examination
blood tests
urine test
poo (stool) test
heart trace (ECG )
a CT scan or an MRI scan of where your cancer is

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.

Side effects

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:

pain, swelling and inflammation where you have the T3P injection. This could be straight after the injection or at a later time.
high temperature
flu-like symptoms
feeling or being sick
muscle aches and pains
headache
swelling and collection of pus (abscess) where you have the injection
sore or ulcer where you have the injection

There is a small chance that T3P might get into your blood. If this happens you might have the following side effects:

high temperature with chills and or shaking (rigors)
flu-like symptoms
increased heart rate
increased breathing rate
low blood pressure

Other important side effects might be:

an infection or abscess in other areas of the body
a severe reaction to the injection causing low blood pressure, difficulty breathing and fainting
arthritis, skin rash and other side effects affecting the immune system

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: