A trial of trastuzumab deruxtecan for cancers that have a large amount of HER2 (DESTINY-PanTumour02)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Bile duct cancer

Biliary tree cancers

Bladder cancer

Cervical cancer

Gallbladder cancer

Ovarian cancer

Pancreatic cancer

Secondary cancers

Womb (uterine or endometrial) cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at trastuzumab deruxtecan for cancers that have a high number of the HER2 receptors (HER2) Open a glossary item .

It is open to people with a cancer that has spread or cannot be removed by surgery. The types of cancers are listed in 'Who can enter'.

More about this trial

Trastuzumab deruxtecan is a combination of 2 drugs. Trastuzumab is a monoclonal antibody Open a glossary item . Deruxtecan is similar to chemotherapy.

Trastuzumab attaches to receptors called HER2 found on cancer cells. Cancers that have a high number of this receptor are HER2 positive cancers. When trastuzumab attaches to these receptors it releases deruxtecan into the cancer cell.

Deruxtecan becomes active when it is in the cancer cell. It works in a similar way to some chemotherapy drugs by blocking an enzyme Open a glossary item that cancer cells need to grow.

In some countries, doctors can use trastuzumab deruxtecan for HER2 positive breast cancer that has spread to other parts of the body.

Researchers think that trastuzumab deruxtecan might help people who have other cancers that are HER2 positive.

In this trial everyone has trastuzumab deruxtecan.

The main aims of the trial are to find out:

how well trastuzumab deruxtecan works for HER2 positive cancers
what the side effects are
what happens to it in the body and how it affects the body
about substances (biomarkers ) that might show how well it is working and who might benefit most

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 you have one of the following cancers:

And all of the following apply. You:

have cancer that has spread into the nearby tissue (locally advanced) or to another part of the body (secondary cancer) or it isn’t possible to have surgery to remove it
have cancer that got worse after treatment to the whole body or there isn’t a standard treatment option available to treat your cancer
have cancer that has a large number of human epidermal receptors. This is HER2 positive cancer.
have a sample of tissue (biopsy) that the trial team can use
have an area of cancer that the doctor can measure
are active but might not be able to do heavy physical work (performance status 0 or 1)
have satisfactory blood test results
have a test that shows your heart works well enough. Your doctor will arrange the test and let you know the results.
are willing to use contraception during treatment and for a certain time after if there is any chance you or your partner could become pregnant
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:

a cancer that has a certain type of DNA change (mutation ) and your cancer does not have a lot of the HER2 protein
adenocarcinoma of the breast, large bowel (colon), back passage (rectum), middle of the stomach, where the food pipe meets the stomach (gastro oesophageal junction) or non small cell lung cancer (NSCLC)
spinal cord compression that needs treatment and is causing symptoms or you are having medication such as steroids or medication that stops fits (anti convulsant)
cancer spread to the brain or spinal cord that is causing symptoms or needs treatment. You might be able to join if you have had treatment for cancer that has spread to the brain, you don’t have any side effects and don’t need further treatment.
ongoing side effects from cancer treatment unless they are mild. You might be able to take part if you have hair loss.
had another cancer within the past 3 years. You might be able to join if you had successfully treated non melanoma skin cancer , a very early cancer (in situ carcinoma ) or a solid cancer .

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

had a heart attack in the past 6 months or another heart problem that could affect you taking part
had a lung, or part of your lung removed or a lung problem that might affect you taking part
have an autoimmune disease that affects the lung, connective tissue or causes inflammation
have fluid on the lungs, around the tummy (abdomen) or around the heart that needs draining or you have had certain treatments such as a tube in the abdomen to drain the fluid. Your doctor will know more about what these treatments are.
have HIV, hepatitis B, hepatitis C or another disease that affects how well your immune system works
have an infection that needs treatment using a drip into a vein (intravenous infusion )
are having medication called chloroquine or hydroxychloroquine unless you stopped taking it for at least 2 weeks before starting the trial treatment
are taking other medication that could make the side effects of the trial treatment worse. Your doctor will check what medications you are taking and will know if this is the case.
are sensitive or allergic to any of the drugs used in the trial or any of their ingredients
are sensitive or allergic to monoclonal antibodies
have any other medical condition or mental health problem that the doctor or the trial team thinks could affect you taking part

Other

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

have a live vaccine within 30 days of starting treatment. You shouldn’t have a live vaccine within 30 days of finishing treatment. Please note that the current approved COVID-19 vaccines are not live vaccines and so you can have them.
are pregnant or breastfeeding

Trial design

This is an international phase 2 trial. The trial team need 280 people worldwide to join with 6 people from the UK.

The team test a sample of tissue (biopsy Open a glossary item ) to check you have large amounts of the HER2 protein on your cancer cells. Please note, you can’t take part in this trial if your cancer cells don’t have large amounts of the HER2 protein.

Everyone has trastuzumab deruxtecan. You have trastuzumab deruxtecan as a drip into a vein. You have it once a week every 3 weeks. This 3 week period is a cycle of treatment Open a glossary item .

You have the first treatment over 90 minutes. After this all other treatments are over 30 minutes if you didn’t have a reaction during the first treatment.

You continue having trastuzumab deruxtecan as long as it is working and the side effects aren’t too bad. You stop treatment if your cancer gets worse. Your doctor will talk to you about other treatment options.

Samples for research
You give extra blood samples during the trial. Whenever possible the team take these when you have your routine bloods.

The team ask you to give a number of tissue samples (biopsies) during the trial.

Researchers will use these blood and tissue samples to find out:

what happens to trastuzumab deruxtecan in the body
how it affects the body
more about the genetics of cancer
more about substances (biomarkers) that might tell them how well treatment is working and why treatment works better for some people

You need to agree to give most of the samples to take part in the trial. There are a few you don’t have to give. Your doctor or a member of the trial team will talk to you about the samples. They will tell you which ones you must agree to and which ones you don’t have to agree to.

Hospital visits

You see the doctor to have tests before taking part. These tests include:

a physical examination
blood tests
eye test
urine test
breathing tests (lung function tests )
CT scan or an MRI scan
heart scan (ECHO or a MUGA )
heart trace (ECG )

You see the doctor once a week for 3 weeks when you have your 1st treatment. You then see them once every 3 weeks on the day you have trastuzumab deruxtecan. This is to see how you are and to take bloods.

You have a CT scan or an MRI scan every 6 weeks.

When you stop treatment you either go to hospital or have a phone appointment. If you choose to go to the hospital you see the doctor within 7 days. If you choose not to go to the hospital the team will phone within 40 days. This to see how you are.

You then see the doctor every 3 months for 12 months. If your cancer has gets worse they will continue to see you every 3 months.

You continue to have a CT scan or an MRI scan every 6 weeks until your cancer gets worse.

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.

The most common side effects of trastuzumab deruxtecan are:

feeling or being sick
tiredness and general weakness (fatigue)
hair loss
constipation or diarrhoea
a drop in blood cells causing an increased risk of infection, bruising and bleeding
loss of appetite
coughing
sore mouth and mouth ulcers
tummy (abdominal) pain
indigestion
headache
dry eyes
dizziness
a change to how your liver works
shortness of breath
inflammation of the lungs
difficulty breathing
severe nose bleeds
skin rash
high temperature (fever)
swelling of the hands and lower legs
colds, a runny nose or a sore throat
low levels of potassium in the blood

Trastuzumab deruxtecan might cause a serious lung problem. In some cases this could be life threatening. Symptoms are similar to other heart or lung diseases. Please contact your doctor straight away if you have any new lung symptoms or symptoms that are getting worse. These include: