A trial of AZD5069 and durvalumab for cancer that started in the liver (CUBIC)

Cancer type:

Liver cancer
Secondary cancers




Phase 1/2

This trial is looking at AZD5069 and durvalumab for the most common type of liver cancer called hepatocellular carcinoma (HCC).        

It is for people who can’t have surgery to remove the cancer because it has spread. This is advanced cancer Open a glossary item.

Cancer Research UK supports this trial. 

More about this trial

Doctors are looking for new treatments for people with liver cancer who can’t have surgery. In this trial they are looking at a new drug called AZD5069 in combination with another drug called durvalumab. 

Durvalumab is a type of immunotherapy. It stimulates the body's immune system Open a glossary item to fight cancer cells. It is already a treatment for some other types of cancer. 

AZD5069 is a new type of targeted drug Open a glossary item. It blocks a protein called CXCR2 which stops the cancer growing. Researchers think that having AZD5069 with durvalumab might help to control the cancer for longer.

The main aims of the trial are to:

  • find the best dose of AZD5069
  • find out how well the combination of treatment works 
  • find out what happens to AZD5069 in the body
  • learn about the side effects

Who can enter

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

You may be able to join this trial if all of the following apply.

  • You have hepatocellular liver cancer that is not suitable for surgery. Your doctor will know this. 
  • You are suitable to have treatment that reaches the whole body (systemic treatment) Open a glossary item.
  • This is your first treatment for liver cancer or you have already had treatment that included sorafenib, lenvatinib, an immunotherapy or certain targeted drugs. If you had treatment, your cancer got worse after no more than one course of treatment or you had to stop due to side effects. The team check which drugs you have had and for how long. 
  • You are willing to have up to 2 biopsies Open a glossary item from your liver to give tissue for the trial team to do some tests on. 
  • Your doctor can measure the cancer on a scan.
  • Your liver is working normally (Child-Pugh score A).
  • Your kidneys are working well.
  • You can swallow tablets.
  • You have satisfactory blood test results.
  • You are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1).
  • You are willing to use reliable contraception during the trial and for a period after if there is any chance you or your partner could become pregnant.
  • You 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 had moderate to severe side effects to past treatment or you had to stop treatment due to side effects caused by an immunotherapy
  • have had treatment for your cancer within 4 weeks of starting trial treatment 
  • have had an experimental treatment within 28 days of starting trial treatment or it hasn’t completely cleared your body 
  • are taking part in another clinical trial unless it doesn’t involve a treatment 
  • have had another cancer that has got worse or needed treatment in the past 5 years unless it has a low chance of coming back. You can join if it was successfully treated non melanoma skin cancer Open a glossary item, prostate cancer, carcinoma in situ Open a glossary item of the cervix, or DCIS Open a glossary item of the breast

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

  • have had a heart attack in the last 12 months or a significant heart problem Open a glossary item that needs treatment. The trial team check if you have a heart condition before you join the trial. 
  • have had a stroke Open a glossary item or mini stroke in the last 12 months
  • have a problem with your digestive system Open a glossary item or a blockage that means you can’t absorb AZD5069
  • have an active hepatitis B infection unless you are having treatment, an active hepatitis C infection unless it has been successfully treated or any other severe infection that needs treatment 
  • have had major surgery in the last 2 weeks
  • have had treatment that damps down the immune system Open a glossary item. This includes steroids Open a glossary item within 2 weeks of starting trial treatment unless it was a low dose.
  • have a problem with how your immune system works 
  • have had an organ transplant Open a glossary item in the past 
  • have an autoimmune condition Open a glossary item that needs treatment apart from certain ones. Your doctor will know about this. 
  • have or had scarring on the lungs or active inflammation of the lungs (pneumonitis) Open a glossary item that needed steroid treatment 
  • have any other medical condition or mental health problem that the trial team think could affect you taking part in this trial

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

  • weigh 30kg or less
  • are allergic to AZD5069, durvalumab or anything they contain
  • are taking drugs that affect enzymes called CYP3A4
  • have had a live vaccination Open a glossary item within 30 days of the start of trial treatment. Please note, the current approved COVID-19 vaccines are allowed as they aren’t live. 
  • are pregnant or breastfeeding  

Trial design

This phase1/2 trial is taking place in the UK. The team need about 50 people to take part in total. 

This trial is in 2 parts:

  • dose escalation (part 1)
  • dose expansion (part 2)

Dose escalation (part 1)
In this part, researchers want to find the best dose of AZD5069. Everyone has AZD5069 and durvalumab. The first few people have a low dose of AZD5069. If they don’t have any side effects the next few people have a higher dose. And so on, until they find the best dose to give. This is a dose escalation study. 

Dose escalation (part 2)
Part 2 starts when they have found the best dose in part 1. In this part the researchers want to test the best dose of AZD5059 in combination with durvalumab in more people. 

Trial treatment and how you have it 
AZD5069 is a tablet. You take it twice a day, every day. The number of tablets and dose you take depends on when you join the trial. 

You have durvalumab as a drip into a vein. You have it once every 4 weeks. It takes about 60 minutes each time. 

You continue to have treatment for up to 2 years as long as it is helping you and the side effects aren’t too bad. 

You stop treatment if your cancer gets worse. The trial team will talk to you about other treatment options. 

Blood and tissue samples
The researchers ask you to give some extra tissue samples. They also ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.

They plan to use the samples to:

  • see how well the treatment is working 
  • see what happens to AZD5069 in the body
  • look at genes Open a glossary item to understand more about liver cancer 
  • look for substances called biomarkers Open a glossary item to help work out why treatment might work for some people and not for others

You need to agree to give all the samples to take part in the trial. 

The team will give you a diary for you to complete during treatment. You write down the side effects you have and any medications you take. 

You need to bring the diary with you every time you go into hospital.

Hospital visits

You see a doctor and have some tests before taking part. These include:

You have durvalumab at the hospital on the day care ward. People in the first part of the trial have a few long hospital visits. These can take up to 12 hours so you might need to stay overnight. The team can tell you more about these visits and what they involve. 

You shouldn’t need to stay overnight if you join the second part of the trial. 

You see the doctor for a check up and blood tests:

  • once a week in the first month 
  • every 4 weeks after that 

You have a CT scan or an MRI scan every:

  • 8 weeks for the first year and then
  • every 12 weeks for the 2nd year 

You stop having these trial scans if your cancer gets worse. 

When you finish treatment you see the doctor 1 month later for a check up. After this, the trial team contact you every 3 months to see how you are. They may call you or see you at a routine hospital appointment. 

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. 

Durvalumab can affect the immune system Open a glossary item. It may cause inflammation Open a glossary item in different parts of the body. This can cause serious side effects. They could happen during treatment, or some 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 durvalumab include:

  • diarrhoea
  • skin rash or itchy skin
  • tummy (abdominal) pain
  • a cough
  • high temperatures (fever)
  • chest infection, a serious lung infection or inflammation of the lungs
  • your thyroid Open a glossary item not making enough hormones. You may feel tired or gain weight.

Only a few hundred people have had AZD5069 so there may be side effects we don’t know about yet. So far, the most common side effects of AZD5069 include:

We have more information about durvalumab


Newcastle upon Tyne

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 Jeff Evans 

Supported by

Cancer Research UK
Cancer Research UK Clinical Trials Unit, Glasgow
NHS Greater Glasgow and Clyde
University of Glasgow

Other information

This is Cancer Research UK trial number CRUK/19/014.

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

Freephone 0808 800 4040

Last review date

CRUK internal database number:


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

Last reviewed:

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