A trial looking at HTL0039732 and other cancer drugs for solid tumours that have spread

The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

Who can take part

 Part 1 (group A)
You may be able to join this part to have HTL0039732 on its own if all of the following apply. You have:

• cancer that has spread elsewhere in the body and standard treatment  has stopped working, there isn’t a suitable standard treatment available or you don’t want to have it 
• at least one area of cancer that your doctor can measure accurately and this has got worse since your last treatment 

 Part 1 (group B)
You may be able to join this part to have HTL0039732 and atezolizumab if all of the following apply. You have:

• cancer that has spread elsewhere in the body and standard treatment has stopped working, there isn’t a suitable standard treatment available or you don’t want to have it 
• at least one area of cancer that the trial team can see on a scan that has got worse. This doesn’t apply to people who have prostate cancer but tests must show your cancer must has got worse. 
• a cancer type that the team think the combination of HTL0039732 and atezolizumab might work for

These include one of the following:

• bowel cancer that is microsatellite stable
• squamous cell cancer  of the head and neck
• prostate cancer and hormone treatment has stopped working or you have had surgery to remove the testicles 
• oesophageal cancer
• stomach cancer
• pancreatic cancer 
• lung cancer
• bladder cancer
• mesothelioma
• cervical cancer
• a type of kidney cancer called renal cancer
• soft tissue sarcoma or bone sarcoma 
• phaeochromocytoma
• any cancer that has a P13K, AKT or mTOR gene change (mutation) . Your doctor will know this.

As well as the above, for both parts, all of the following must also apply. You:

• have a sample of tissue (biopsy ) available that the trial team can access or you are willing to give a new sample. Please note, you need to give 2 new samples to take part if you join group B. The team collect these samples when you join the trial and another one during the trial.
• have satisfactory blood test results 
• are active but might not be able to do heavy physical work (performance status 0 or 1)
• are willing to use reliable contraception during the trial and for a period after 
• are at least 18 years old  

Who can’t take part

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

• have cancer spread to the brain unless you have had treatment, the cancer is stable and you haven’t had steroids  for at least 4 weeks
• have had radiotherapy in the last 4 weeks unless it was to help with symptoms of cancer (palliative radiotherapy)
• have had chemotherapy, another treatment to the whole body or an experimental treatment in the 4 weeks before joining the trial. You might be able to take part if you are having certain hormone treatments for prostate cancer or it has been more than 6 weeks since you had chemotherapy drugs called nitrosoureas  or a drug called mitomycin C .
• have had an immunotherapy  in the 12 weeks before having HTL0039732
• have side effects from past treatments that aren’t getting better unless they are mild. You can take part if you have hair loss or some other side effects that the doctor thinks won’t get worse if you join the trial. 
• are taking an experimental drug as part of a clinical trial or you are due to join one

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

• have had major surgery to your chest or tummy area (abdomen) and you aren’t better yet 
• have or have had TB, HIV, hepatitis B, hepatitis C or any other active infection that needs treatment 
• have had treatment with HTL0039732 or a similar drug in the past. Your doctor will know this.
• have had treatment with a type of drug called a COX-2 inhibitor  in the 8 weeks before you join the trial. Your doctor will know this. 
• have had treatment that damps down the immune system. This includes steroids within 2 weeks of starting trial treatment unless it was a low dose
• have a significant heart problem  or heart condition that isn’t well controlled with medication. Your doctor checks your heart before you join the trial. 
• have a problem swallowing or a digestive problem  that means you can’t absorb medication
• have a stomach ulcer, inflammation of the stomach, indigestion or heartburn that is causing symptoms 
• have any other medical condition or mental health problem that could affect you taking part 

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

• are allergic to the substance that the capsules are made of
• are pregnant or breastfeeding 

As well as the above, to join part 1, group B, the following can’t apply. You 

• have had a live vaccine  in the 4 weeks before joining the trial. Please note, this doesn't apply to the approved COVID-19 vaccines or flu vaccines as they aren't live. 
• have a problem with how your immune system  works
• have an autoimmune condition  that needed treatment in the last 2 years 
• have scarring of the lungs, active inflammation of the lungs (pneumonitis ) or you had inflammation of the lungs that needed treatment in the past 
• are allergic to atezolizumab or anything it contains