A trial of CCS1477 for prostate cancer and other solid tumours

Cancer type:

All cancer types
Prostate cancer
Secondary cancers

Status:

Open

Phase:

Phase 1/2

This trial is for people with a solid tumour that has spread elsewhere in the body. This is advanced cancer or metastatic cancer. 

A solid tumour Open a glossary item is any cancer apart from blood cancers such as:

  • leukaemia 
  • lymphoma 
  • myeloma 
     

More about this trial

Doctors are looking for new treatments for people with advanced cancer when other treatments have stopped working. In this trial they are looking at a new drug called CCS1477.

CCS1477 is a targeted drug. It stops signals that cancer cells use to divide and grow. Researchers think that it might slow cancer growth. But they aren’t sure so want to find out more. 

The researchers plan to look at how CCS1477 works in men who have advanced prostate cancer. And to find out the best dose to have in combination with hormone treatment for prostate cancer. These include abiraterone and enzalutamide

They are also looking at how CCS1477 works for people with other advanced solid tumours. 

The main aims of the trial are to:

  • find the best dose of CCS1477
  • find out what happens to CCS1477 in the body 
  • look at having CCS1477 with abiraterone or enzalutamide for men with prostate cancer 
  • find out how well CCS1477 works

Who can enter

The following bullet points list the main 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. 

There are 5 main treatment groups in this trial. Groups A, B, C and D are for men with prostate cancer. And group E is for people with any solid tumour.

Who can take part

To join group A, B, C or D the following must apply.

  • You have prostate cancer that has spread elsewhere in the body despite having hormone treatment Open a glossary item.
  • You have had abiraterone and or enzalutamide. 
  • You have had a chemotherapy drug such as docetaxel
  • Your PSA levels  Open a glossary itemand or scans show that your cancer is getting worse.
  • The amount of PSA in your blood when you join the trial is more than 2ng/dl. 
  • You have very low levels of testosterone  Open a glossary item(less than 50 ng/dL).

To join group E the following must apply. You: 

  • have a solid tumour that has spread elsewhere in the body and there is no other suitable treatment available 
  • have certain genetic changes (mutations Open a glossary item) on your cancer cells (the trial team check this with a tissue or blood sample)  

As well as the above entry conditions for each group, the following must apply for all the groups. You:

  • have a cancer that your doctors can see on a scan 
  • have satisfactory blood test results 
  • are well enough to carry out all your normal activities but might not be able to do heavy physical work (performance status of 0 or 1)
  • are willing to use reliable contraception during treatment and for 3 months afterwards if you or your partner could become pregnant. You are willing to use a condom during treatment and for 1 week after if you are a man and can pass your sperm to another person 
  • are at least 18 years old 

Who can’t take part

You cannot join this trial if any of the following apply. These are the main exclusion conditions. 

Cancer related 
You: 

  • have cancer that started in the brain or cancer that has spread to the brain. You might be able to take part if you have had treatment for cancer that has spread to the brain and you haven’t had symptoms in the 28 days before starting the trial drug. 
  • have had chemotherapy, an anti cancer drug, or an experimental treatment in the last 14 days or a treatment that hasn’t completely cleared your body. This does not apply to abiraterone or enzalutamide. The team decide about any immunotherapy Open a glossary item you may have had on a case by case basis
  • have had radiotherapy to more than 30% of the bone marrow within 4 weeks of trial treatment 
  • have had another cancer in the past apart from non melanoma skin cancer Open a glossary item or carcinoma insitu (CIS Open a glossary item) that has been successfully treated 

Medical conditions
You:

  • have had major surgery or a very bad injury within 4 weeks of trial treatment or you might need major surgery
  • take medication for high cholesterol (statins) that you can’t stop taking. You should never stop taking a medication without first talking to your doctor.
  • have side effects from past treatments that aren’t getting better unless they are mild apart from hair loss or numbness and tingling in the hands or feet (peripheral neuropathy Open a glossary item)
  • have an active infection including hepatitis B, hepatitis C or HIV 
  • have congestive heart failure that is causing problems, high blood pressure that isn’t well controlled with medication, angina that isn’t well controlled with medication or an abnormal heart rhythm 
  • have a heart condition called a QT prolongation 
  • have a medical condition that means you are more likely to have a bleed 
  • have taken any medication that blocks an enzyme called CYP3A4 in the 4 weeks before joining this trial
  • have taken a herbal medicine in the 7 days before starting trial treatment or you have taken St John’s wort in the last month 
  • have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial

Other
You:

  • are allergic to any of the trial medications or anything they contain
  • are pregnant or breastfeeding 

Trial design

This is a phase 1/2 trial. The researchers need 250 people from the UK and the US to take part. This includes 180 from the UK.

There are 5 treatment groups in this trial. Which treatment group you are in depends on your cancer type and the entry conditions of the trial. 

CCS1477 is a capsule. The team tell you how many to take. You take them in the morning with a glass of water. You must fast (water only) for at least 2 hours before taking your trial medications and for at least 1 hour after. 

Everyone has treatment for as long as it is working, and the side effects aren’t too bad. 

Group A   finding the best dose of CCS1477 in men with prostate cancer
Group B  testing the best dose CCS1477 in more men with prostate cancer
Group C looking at the combination of CCS1477 and abiraterone for men with prostate cancer
Group D looking at the combination of CCS1477 and enzalutamide for men with prostate cancer
Group E looking at the best dose of CCS1477 in people with any solid tumour

 

Group A
Group A is for men with prostate cancer. The first few men have a low dose of CCS1477. If they don’t have bad side effects, the next few have a higher dose. And so on until they find the best dose. This is a dose escalation study.

Group B 
Group B is for men with prostate cancer. When they find the best dose of CCS1477 in group A then group B can open. 

The researchers are looking at 2 different doses and or schedules in a larger group of men. 

The team tell you how often to take CCS1477 and how many to take. 

The researchers might ask you to join an extra part of the trial. This is looking at what happens to CCS1477 in the body if you take it with or without food. The team let you know if you will be involved in this research.

Group C 
Group C is for men with prostate cancer. In this group you have CCS1477 and a prostate cancer drug called abiraterone. It is a hormone therapy drug. 

There are 2 parts. Part 1 is looking at the best dose of CCS1477 to have alongside abiraterone. Part 2 is testing this dose level and combination in a larger group of men.

Abiraterone is a tablet. You take them at the same time as you take CCS1477. The team let you know how much CCS1477 to take and how often to take it.

Everyone in group C also takes a steroid drug called prednisolone. 

Group D
This group is for men with prostate cancer. In this group you have CCS1477 and a prostate cancer drug called enzalutamide. It is a hormone therapy drug. 

There are 2 parts. Part 1 is looking at the best dose of CCS1477 to have alongside enzalutamide. Part 2 is testing this dose level and combination in a larger group of men. 

Enzalutamide is a capsule. You take them once a day, everyday. You have them at the same time as you take CCS1477. The team let you know how much CCS1477 to take and how often to take it. 

Group E 
This group is for people who have any solid tumour. 

There are 2 parts. Part 1 is looking at the best dose of CCS1477 to have. Part 2 is testing this dose in more people.  

CCS1477 is a capsule. The team let you know how much CCS1477 to take and how often to take it. 

Hospital visits

You see a doctor and have some tests before you can take part in the trial. These include:

For those with a solid tumour, the researchers do some tests to look for specific gene changes in your cancer cells. They use a tissue sample (biopsy)  Open a glossary itemor blood test to do this. 

Everyone has regular check ups during treatment. The team can tell you more about how often these happen.

At some visits you might need to stay overnight at the hospital or at a nearby hotel and return to the hospital in the morning. 

You have a CT scan or MRI scan every:

  • 2 months for 6 months
  • 3 months after that 

You see the trial team one month after you stop treatment for a check up. 

Samples for research
The team ask for a sample of tissue from a previous surgery or biopsy. Some people in the trial need to give 3 extra tumour samples. The team tell you if this applies to you. 

Everyone also gives some extra blood samples. Where possible you give these at the same time as your routine blood samples. 

The researchers plan to use the samples to:

  • look for biomarkers Open a glossary item
  • find out what happens to the drug in the body (pharmacokinetics Open a glossary item).
  • find out more about how treatment works  

Side effects

The trial 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. 

CCS1477 is a new drug so there might be some side effects that the researchers don’t know about yet. 

So far the most common reported side effects in people with solid tumours include:

CCS1477 can make you more sensitive to sunlight. You should avoid going out in the sun for long periods during treatment and for 4 weeks afterwards. You should cover up and try to stay in the shade. The team advise you to apply a sunscreen that is SP30 or higher. 

You should not take any herbal medication during treatment. Nor should you have large amounts of grapefruit or Seville oranges. These can interfere with how treatment works. 

The most common side effects of abiraterone include:

  • swelling of legs or feet
  • urine infections
  • high blood pressure
  • low levels of potassium in your blood
  • diarrhoea

The most common side effects of enzalutamide include:

We have more information about:

Location

Belfast
Birmingham
Cambridge
Edinburgh
Glasgow
Leicester
Manchester
Newcastle upon Tyne
Southampton
Sutton

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Johann De Bono

Supported by

CellCentric Ltd

Freephone 0808 800 4040

Last review date

CRUK internal database number:

17061

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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