A trial of CCS1477 for solid tumours

Cancer type:

All cancer types
Breast cancer
Lung cancer
Non small cell lung cancer
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 called advanced cancer, metastatic cancer or secondary 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 trial team are looking at how CCS1477 works on its own for people with advanced solid tumours. They are also looking The researchers plan to look at how CCS1477 works in combination with other treatments. These include:

  • abiraterone – a standard hormone treatment for prostate cancer 
  • enzalutamide – a standard hormone treatment for prostate cancer
  • darolutamide – a new hormone treatment for prostate cancer
  • olaparib – a targeted cancer drug 
  • atezolizumab – an immunotherapy Open a glossary item

The treatment you have depends on your cancer type and the group you join. 

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 on its own and in combination with other cancer drugs  
  • 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 8 main treatment groups in this trial. It is for people who have one of the following:

Please note, 4 of the groups have closed to recruitment. 

Who can take part

    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)  

    To join group F 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 G the following must apply. You:

    • are having olaparib and it isn’t working very well within 3 months of starting it 
    • aren’t having side effects from olaparib and you are going continue having olaparib 

    To join group H the following must apply. You: 

    • have non small cell lung cancer locally advanced or cancer that has spread to another part of the body after chemotherapy. Those who had an EGFR gene change or ALK-positive cancer must have had a targeted cancer drug

    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. 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 350 people from the UK, EU and the US to take part. This includes 180 from the UK.

    There are 4 treatment groups open for people to join. 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 E looking at the best dose of CCS1477 in people with any solid tumour
    Group F looking at the combination of CCS1477 and darolutamide for people who have prostate cancer
    Group G looking at the combination of CCS1477 and olaparib for people who have prostate or breast cancer
    Group H looking at the combination of CCS1477 and atezolizumab for people who have non small cell lung cancer  

    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. 

    Part F
    This group is for men who have prostate cancer. In this group, you have CCS1477 and a new hormone treatment called darolutamide. 

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

    Darolutamide is a tablet. You take them twice a day, every day. 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.

    Part G
    This group is for people who have prostate or breast cancer that has spread to another part of the body. In this group you have CCS1477 and a targeted drug called olaparib

    There are 3 parts. Part 1 is looking at the best dose of CCS1477 to have with olaparib. Part 2 is testing this dose level and combination in more people who have prostate cancer. Part 3 is testing this dose level and combination in more people who have breast cancer that has spread. 

    Olaparib is a tablet. You take them twice a day, every day. 

    Part H
    This group is for people who have non small cell lung cancer that has spread. In this group you have CCS1477 and an immunotherapy called atezolizumab

    There are 2 parts. Part 1 is looking at the best dose of CCS1477 to have with atezolizumab. Part 2 is testing this dose level and combination in more people who have advanced lung cancer. 

    You have atezolizumab as a drip into a vein. You have this every 3 or 4 weeks. You have it at the same time as you take CCS1477. The team let you know how much CCS1477 to take and how often to take it.
     

    Groups A, B, C and D were for people with prostate cancer. They all had CCS1477. Some people also had a drug called abiraterone and some people also had a drug called enzalutamide. These groups are now closed to recruitment. 

    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. 

    Atezolizumab affect the immune system. Open a glossary item This may cause inflammation Open a glossary item and other reactions in different parts of the body. For many people the inflammation and reactions are not too bad. For some people they can cause serious side effects. 

    These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for.
     
    If you have any of these side effects tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy.

    The most common side effects of atezolizumab include:

    • fever
    • feeling or being sick
    • tiredness (fatigue)
    • lack of energy
    • itchy skin or skin rash 
    • diarrhoea
    • joint pain
    • loss of appetite
    • shortness of breath
    • urine infections
    • back pain
    • cough
    • headache

    The most common side effect of darolutamide is tiredness.

    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

    If you have questions about the trial please contact our cancer information nurses

    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.

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