A study looking at AZD8205 for cancer that has spread or come back after treatment (Sub-study 1)

Cancer type:

Bile duct cancer
Biliary tree cancers
Breast cancer
Ovarian cancer
Secondary cancers
Womb (uterine or endometrial) cancer

Status:

Open

Phase:

Phase 1/2

This study is looking at a drug called AZD8205. It is for solid cancers that have spread to another part of the body or have come back after treatment. A solid cancer is any cancer apart from a blood cancer such as leukaemia.

It is open to people with:

More about this trial

AZD8205 is a targeted drug Open a glossary item called an antibody drug conjugate (ADC). 

There are 2 parts to an ADC, the antibody part and the treatment part. The antibody part delivers the treatment directly to the cancer cells. It does this by seeking out certain proteins on the cancer cell. It then attaches to the cancer cell and releases the treatment part into the cancer cell. The treatment could be chemotherapy or radiotherapy. 

Doctors already use ADCs to treat cancers such as breast cancer, bladder cancer and other cancer types. 

AZD8205 is a new type of ADC. It targets a protein called B7-H4 that is found on some cancer cells. The treatment part is a type of chemotherapy. 

In this study the team will test a sample of tissue taken from your cancer to see if the B7-H4 protein is there. 

The aims of this study are to find out:

  • how well AZD8205 works for different cancer types
  • what happens to AZD8205 in the body and how it affects the body
  • more about the side effects
  • how many people develop antibodies to AZD8205

Who can enter

The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study 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 study if you have one of the following:

  • breast cancer
  • bile duct cancer
  • ovarian cancer
  • womb (endometrial) cancer  

And all of the following apply. You:

  • have cancer that has spread to another part of the body or has come back after treatment
  • have had the standard treatment Open a glossary item for your cancer type or your doctor thinks that taking part in a clinical trial Open a glossary item is your next best treatment option
  • have an area of cancer that the doctor can measure on a scan Open a glossary item
  • are willing to have a tissue sample (biopsy Open a glossary item) taken when you join the study and during it
  • can look after yourself but might not be able to do heavy physical work (performance status 0 or 1)
  • have satisfactory blood test results
  • are willing to use reliable contraception during treatment and for a time after if there is any chance you or your partner could become pregnant
  • have veins that are good enough to have a drip (intravenous infusion). Your doctor will know about this.
  • are at least 18 years old

Who can’t take part

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

  • have cancer that has spread to the brain. This is unless you have had treatment, you have no symptoms and it is stable. You don’t need steroids Open a glossary item or you are taking a small dose for at least 4 weeks before starting the study treatment.
  • have areas of cancer in the tissue surrounding the brain and spinal cord
  • have had cancer treatment within the past 21 days. If you have had mitomycin C and nitrosourea it needs to be 6 weeks since you had it. For targeted cancer drugs Open a glossary item such as immunotherapy Open a glossary item or monoclonal antibodies Open a glossary item it is 28 days. Your doctor will know about this. 
  • have had radiotherapy that covered a large area within the past 4 weeks. For radiotherapy to a small area or for symptom relief it is 2 weeks. Your doctor will know about this.
  • have ongoing side effects from previous treatment unless they are mild or are certain ones such as hair loss. Your doctor will know more about this.
  • have or had another cancer. This is apart from successfully treated non melanoma skin cancer Open a glossary item, carcinoma in situ Open a glossary item, lentigo maligna melanoma or a primary cancer Open a glossary item that is not an invasive cancer Open a glossary item and is monitored. You could take part if you had a cancer that was treated with the aim to cure and there has not been any sign of it for at least 2 years. 

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

  • have major surgery within 28 days of starting the study treatment
  • have spinal cord compression Open a glossary item
  • have HIV, hepatitis B, hepatitis C or any other active infection. You could take part if you had hepatitis B or hepatitis C in the past but you don’t have it now.
  • have lung problems Open a glossary item that could affect you taking part. Your doctor will know about this.
  • have high blood pressure that isn’t controlled
  • have heart problems Open a glossary item such as you have had a heart attack or unstable chest pain (angina) within the past 6 months. Or you have a history of heart problems that could affect you taking part. Your doctor will know about this.
  • are taking part in another clinical trial. That is unless it is an observational trial or you have finished the treatment and are in the follow up part of the trial.
  • had another illness such as diarrhoea within the past year that was not controlled
  • are taking medication that could affect you taking part. Your doctor will know which these are.
  • have any other medical condition, mental health problem or social problem that could affect you taking part

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

  • are allergic or sensitive to the study treatment or any of its ingredients
  • have a live vaccine Open a glossary item within 30 days of starting the study treatment. You must not have a live vaccine while having treatment or for at least 30 days after treatment. The COVID-19 and seasonal flu vaccines are not live vaccines.
  • have previously taken part and had treatment in this study
  • are pregnant, intending to get pregnant or breastfeeding

Trial design

This is an international phase 1/2 study. The team need up to 280 people worldwide with 8 people in the UK to take part.

When you agree to join the study you give a sample of cancer tissue (biopsy Open a glossary item). The team test this for a protein called B7-H4. You can continue in the study if there is a high amount of B7-H4 in the biopsy. 

If there is not a high amount of B7-H4 your doctor will discuss what other treatment options there might be. 

There are 2 parts to this study. 

Part A was to find the best dose of AZD8205 to give. The best dose is the one that is safe and has the fewest side effects. This part is now closed to recruitment. 

Everyone joining the study now will go into part B. In this part the team are looking at 4 different doses of AZD8205. 

You have AZD8205 as a drip into a vein once every 3 or 4 weeks. Each 3 week or 4 week period is called a cycle of treatment Open a glossary item.

Which dose you have and which cycle of treatment you have might be decided at random Open a glossary item. Your doctor will tell you which dose you are having and whether you are having the 3 or 4 week cycle of treatment. You continue to have AZD8205 as long as it is helping and the side effects aren’t too bad. 

Samples for research
You have some extra blood tests when you join the study and during the study. Where possible, you have these at the same time as your routine blood tests.

They will use these samples to:

  • find out more about AZD8205, what happens to it in the body and how it affects the body
  • look for pieces of the cancer DNA Open a glossary item (ctDNA) in the blood that might give more information about your cancer type and how well the treatment is working
  • look for antibodies Open a glossary item that your body might make against AZD8205

Optional samples for research
The team will ask for a sample of:

  • tissue if your cancer gets worse during treatment
  • the build up of fluid around your lung or around your tummy if this happens due to your cancer  

You don’t have to agree to have these samples taken to take part in the study.

AZD8205 might cause side effects that affect the tissue of the body. For example it can cause a skin rash. They team will ask for a sample of this tissue. 

Your doctor will only take these samples if it is safe to do so and you agree to have them taken.

Hospital visits

You see the doctor to have tests. These include:

  • a physical examination Open a glossary item
  • blood tests
  • urine test
  • heart trace (ECG)
  • heart scan (ECHO or a MUGA Open a glossary item)
  • either a CT scan, an MRI scan or both

You see the doctor regularly during treatment. This is to see how you are and for blood tests. 

You have a scan every 6 weeks for just over a year and then every 9 weeks.

You see the doctor a month after finishing treatment and then every 3 months.  

Side effects

The study 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. 

AZD8205 is a new drug and there might be side effects we don’t know about yet. The side effects reported so far include:

While having AZD8205 or soon after you might have the following side effects. Tell your nurse or doctor if you have any these side effects. They include:

  • high temperature (fever)
  • chills
  • sore or aching muscles
  • feeling or being sick
  • itching
  • a skin rash
  • a headache
  • reddening of the skin (flushing)
  • sweating
  • an increased heart rate
  • difficulty breathing
  • dizziness
  • light headedness 
  • a drop in blood pressure

A rare side effect of AZD8205 is a severe allergic reaction. This can happen within minutes or up to 24 hours of having AZD8205. The symptoms can be similar to some or all of the side effects listed. Other symptoms include:

  • swelling of the vocal cords
  • swelling of the voice box
  • swelling of the face
  • not been able to think clearly
  • difficulty breathing 

This can be life threatening. Contact your doctor straight away if you have any of these symptoms.

Your doctor will discuss any possible side effects of the treatment and answer any of your questions before you agree to take part.

Location

Cambridge
Cardiff
London

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 Peter Schmid

Supported by

AstraZeneca

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

Freephone 0808 800 4040

Last review date

CRUK internal database number:

19421

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

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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