A trial of datopotamab deruxtecan for cancer that has spread (TROPION PanTumour03)

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:

• womb (endometrial)
• stomach (gastric) 
• bowel (colorectal)
• prostate
• ovarian – including cancer of the fallopian tube or primary peritoneal cancer

And all of the following apply: You:

• have cancer that has spread into nearby tissues, or to another part of your body, and your team think the treatments used in the trial could be suitable for you
• can look after yourself but might not be able to do heavy physical work (performance status 0 or 1). Your general health has not got worse in the 2 weeks before you have your first tests with the trial team or your first dose of the trial drug.
• have a tissue sample (biopsy)  that the trial team can access. If not, you are willing to have a fresh tissue sample taken.
• have at least 1 area of cancer that the doctor can measure on a scan . You must not have had radiotherapy to this area before. Those with prostate cancer might be able to take part if the cancer has spread to the bone marrow  and the doctor can confirm this with a test.
• 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. Your trial team can talk about suitable contraception for you and your partner if needed.
• won’t donate or bank sperm during the time you are taking part in the trial  
• won’t donate blood or platelets during the study and for the 28 days after your last trial treatment
• won’t use contact lenses during the trial and for 28 days after the last dose of datopotamab deruxtecan
• are able to use artificial tears during the trial and for 28 days after the last dose of datopotamab deruxtecan
• are at least 18 years old

Who can’t take part

You cannot join this trial if any of these apply.

Cancer related

You:

• have, or had, another solid tumour  unless it has been successfully treated, there have been no signs of it for at least 3 years and it is unlikely to come back. You might be able to join if you have had basal cell skin cancer  or squamous cell  skin cancer that has been removed. You might also be able to take part if you have had early (in situ) cancers and you have had treatment to try and completely remove them.
• have side effects from your past cancer treatments unless they are mild. You might be able to take part if you have hair loss or a side effect that won’t get worse with treatment. Your doctor will know this.
• have cancer spread to the brain or spinal cord unless it is stable and doesn’t need treatment.
• have had whole brain radiotherapy or stereotactic radiotherapy  in the 2 weeks before joining the trial
• have had radiotherapy to a smaller area to help with symptoms in the 2 weeks before starting the trial treatment 
• have had radiotherapy to just over a quarter (30%) of your bone marrow  in the 4 weeks before starting the trial treatment. Your doctor will know this. 
• have cancer that has spread to the membranes that surround the brain (leptomeningeal carcinomatosis)
• are having, or have had, cancer treatment within a certain time of starting the trial treatment. Your doctor will know how long this is for each cancer treatment. You may be able to take part if you are having hormone therapy not for cancer (such as HRT  )
• have had treatment similar to datopotamab deruxtecan before. Your doctor can tell you more.

Medical conditions
You:

• have had an organ transplant
• have an active bleeding problem
• have a serious problem with the outermost lens (cornea) in your eye
• have HIV that isn’t well controlled with medication, an active hepatitis or an uncontrolled hepatitis B or hepatitis C infection, an active TB infection or any other infection that needs systemic treatment  
• have lung problems  that could affect you taking part including scarring or inflammation of the lungs 
• have had a heart attack in the last 6 months or any other heart problem  that might affect you taking part. The trial team check if you have a heart condition before you join the trial.
• had major surgery or a major injury within 3 weeks of starting treatment. Or you might need surgery during the trial.
• have any other medical condition or mental health problem that could affect you taking part 

Other
You:

• have already taken part in this trial or have had an experimental drug or used a device as part of another clinical trial within 4 weeks of starting treatment
• are allergic or sensitive to datopotamab deruxtecan or any of its ingredients
• are taking anti malaria medication called chloroquine or hydroxychloroquine within 2 weeks of your first dose of the trial drug
• have a live vaccine  within 30 days of starting treatment. The COVID-19 vaccines are not live vaccines.
• are pregnant, breastfeeding or planning to become pregnant
• have been involved in the planning of the trial or have been working on the trial yourself

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.