
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
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 is any cancer apart from blood cancers such as:
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:
The treatment you have depends on your cancer type and the group you join.
The main aims of the trial are to:
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:
To join group F the following must apply.
To join group G the following must apply. You:
To join group H the following must apply. You:
As well as the above entry conditions for each group, the following must apply for all the groups. You:
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:
Medical conditions
You:
Other
You:
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.
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 (or 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:
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:
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 This may cause
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:
The most common side effect of darolutamide is tiredness.
We have more information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Johann De Bono
CellCentric Ltd
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.