
"I am glad that taking part in a trial might help others on their own cancer journey.”
This trial is looking at a new drug called datopotamab deruxtecan (Dato Dxd) on its own, or with other treatments, for some . It is for people whose cancer has spread to nearby tissues or to another part of the body.
It is open for a number of different cancer types, to find out which look in ‘who can enter’.
Cancer that has spread is called . And cancer that has spread further away from where it started is called
. Advanced or metastatic cancer can be more difficult to treat.
Researchers think datopotamab deruxtecan might help people with certain types of advanced or metastatic cancer. Researchers are trying to find out whether it will help in the types of cancers in this trial. The side effects seen so far in other studies have been manageable and this trial will find out more.
Datopotamab deruxtecan is called an antibody drug conjugate (ADC). It’s a combination of 2 drugs. Datopotamab is a . It attaches to cancer cells that have a protein called TROP2 on them. It then releases deruxtecan into the cancer cell. Deruxtecan is the
part of the drug. It kills or damages the cancer cell.
In this trial everyone has datopotamab deruxtecan. You might also have it with other cancer drugs. These include:
Durvalumab is a type of . It stimulates the body's
to fight cancer cells.
AZD5305 is a drug called a PARP inhibitor. PARP is a protein (enzyme) found in our cells. It helps damaged cells to repair themselves. PARP inhibitors stop the PARP from doing its repair work in cancer cells and the cell dies.
The other drugs you may have depend on your cancer type.
The aims of the trial are to:
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.
Please note, there are several study groups so the entry conditions for this trial are complex. Each study has specific entry conditions, and we haven’t listed them all.
The study you join depends on your cancer type.
Who can take part
You may be able to join the trial if you have one of the following cancers:
And all of the following apply: You:
Who can’t take part
You cannot join this trial if any of these apply.
Cancer related
You:
Medical conditions
You:
Other
You:
As well as the above there are specific entry conditions and exclusion criteria for each treatment group. Speak to your doctor or research nurse if you want to find out more about the entry conditions for this trial.
This is an international phase 2 trial. The team need up to 550 people worldwide to join, including 40 from the UK.
There are 5 studies which together make up the trial. Each study is looking at a cancer type.
Womb (endometrial) cancer - study 1
There are 4 different treatment groups in this study.
Not all study treatment groups will be open at the same time. Your study doctor will let you know which treatment groups are open and which is right for you.
Group 1 – you have datopotamab deruxtecan only
Group 2 – you have datopotamab deruxtecan and durvalumab
Group 3 – you have datopotamab deruxtecan and AZD5305
Group 4 – you have datopotamab deruxtecan, durvalumab and AZD5305
You have datopotamab deruxtecan as a drip into a vein. You have it once every 3 weeks.
You have durvalumab as a drip into a vein. You have it once every 3 weeks.
AZD5305 is a tablet. Your study doctor will tell you how often you take your tablets.
Stomach (gastric) cancer - study 2
Please note, if one of these groups is not open when you join, the team will let you know. The doctor will give you information about what group is open and you will join the group.
There are 2 different treatment groups in this study. It is a randomised study. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in. There are 2 treatment groups.
Group 1 – datopotamab deruxtecan and capecitabine chemotherapy
Group 2 – datopotamab deruxtecan and fluorouracil (5FU) chemotherapy
You have datopotamab deruxtecan as a drip into a vein. You have it once every 3 weeks.
You have capecitabine chemotherapy as a tablet, one in the morning and one in the evening.
You have fluorouracil chemotherapy as a drip into a vein by a small pump that you carry around for 5 days.
Your team will explain to you which of the drugs you have and when.
Prostate cancer - study 3
There are 2 different treatment groups in this study. Your study doctor will let which treatment group you will be in.
Group 1 – you have datopotamab deruxtecan only
Group 2 – you have datopotamab deruxtecan and AZD5305
You have datopotamab deruxtecan as a drip into a vein. You have it once every 3 weeks.
You have AZD5305 as a tablet. Your study doctor will tell you how often you take your tablets.
Ovarian cancer - study 4
There are 2 different treatment groups in this study.
Not all study treatment groups will be open at the same time. Your study doctor will let you know which treatment groups are open and which one you will be in.
Group 1 – you have datopotamab deruxtecan only
Group 2 – you have datopotamab deruxtecan, carboplatin chemotherapy and AZD5305
In group 1, you have datopotamab deruxtecan as a drip into a vein. You have it once every 3 weeks.
In group 2 you have datopotamab deruxtecan and carboplatin chemotherapy for 6 . You also have carboplatin as a drip into a vein.
After this, you have datopotamab deruxtecan and AZD5305 as maintenance treatment. This is to try and stop the cancer coming back. AZD5305 is a tablet. Your doctor will let you know when to take your tablets and for how long.
Bowel (colorectal) cancer - study 5
Everyone has datopotamab deruxtecan as a drip into a vein. You have it once every 3 weeks. You might have other cancer drugs alongside the datopotamab deruxtecan. Your doctor will let you know which other drugs you have and when.
For all groups
You have . You may be in the trial for around 18 months. But you continue to have treatment for as long as it is working, and the side effects aren’t too bad.
The team will ask you to use an electronic application, TrialMax app, during the trial. You will be given an electronic device with the app on if you don’t have your own. The app will support you during the study. You also use it to record how you are feeling. Your study doctor will tell you more about this.
Samples for research
The researchers ask for a sample of your cancer before you have the trial drug. They will use a sample that is already available if it is suitable. And they ask for a tissue sample when you are having treatment with the trial drug. This is so they can learn more about how the treatment works for your type of cancer.
The researchers might also ask for a lung tissue sample if you have disease in your lungs called , to get more information on this condition.
If your cancer starts to grow, the researchers would be interested in taking a sample for research. This is so they can learn more about why some cancers grow when you are having treatment.
If your cancer grows, or comes back, in the future the team might ask to take another tissue sample. They would like to look at:
You don’t have to give these samples if you don’t want to. You can still take part in the trial.
Blood samples for research
The trial team 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 look more closely at the involved in developing cancer.
You don’t have to give these samples if you don’t want to. You can still take part in the trial.
You see the doctor and have tests before you can take part. This might be over 1 or 2 days.
The tests you have depend on your cancer type but include:
You might also have:
Usually, you go to the hospital once every 3 weeks to have:
You have datopotamab deruxtecan as an outpatient. You should not need to stay overnight for any of the treatments in the trial.
You might need to go to the hospital more often than every 3 weeks. It depends on what treatments you are having and how you are feeling.
Follow up
After treatment has finished, you go back to the hospital between a month and 3 months after the last dose of the trial drug. This is so that the trial team can check how you are getting on.
You might have extra visits for scans every 6 weeks. A member of the trial team will call you every 3 months to ask about your health.
Follow up is different depending on your cancer type and treatment group. Your doctor will let you know your individual follow up plans.
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.
Datopotamab deruxtecan is a new drug so there may be side effects we don’t know about yet. The possible side effects we know about so far include:
Datopotamab 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:
Getting medical treatment right away may keep these problems from becoming more serious.
Using AZD5305 with other drugs is new, so there may be more side effects we don’t know about yet. The possible side effects of AZD5305 we know about so far include:
Please note, if you have any fast or uneven heartbeats, light headedness, shortness of breath, fainting or vision problems you should contact your trial doctor immediately.
Durvalumab can affect the 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. |
The most common side effects of durvalumab include:
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.
Dr Rebecca Kristeleit
AstraZeneca
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”