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

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