A trial looking at MDX-124 for solid tumours that have spread (ATTAINMENT)

Cancer type:

All cancer types

Pancreatic cancer

Status:

Open

Phase:

Phase 1

This trial is looking at a new drug called MDX-124 for solid tumours that have grown into surrounding tissues or spread elsewhere in the body.

A solid tumour is any type of cancer apart from blood cancers such as leukaemia Open a glossary item and lymphoma .

Cancer that has spread is advanced cancer Open a glossary item .

More about this trial

Standard treatments Open a glossary item for solid tumours include surgery, chemotherapy and radiotherapy. Sometimes cancer comes back after treatment. So doctors are looking for new treatments to give when standard treatments have stopped working for advanced cancer.

In this trial they are looking at a drug called MDX-124. It is a type of targeted cancer drug Open a glossary item called a monoclonal antibody . It targets a protein called ANXA1 that is found in higher than normal levels in many solid tumours. MDX-124 attaches to ANXA1 and stops the signals that cancer cells use to divide, grow and spread. It also helps the immune system to find and kill cancer cells.

There are 2 parts to this trial. In the first part, the team are looking at the best dose of MDX-124 to give. In the second part they are testing this dose in combination with chemotherapy for people who have pancreatic cancer.

The main aims of the trial are to:

find the best dose of MDX-124 to give
find out how well MDX-124 works on its own and in combination with chemotherapy
see how safe MDX-124 is
find out what happens to MDX-124 in the body
see what the side effects are

Who can enter

The following bullet points are a summary of the main 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 part 1 of the trial if all of the following apply. You:

have a solid tumour that is believed to have higher than normal levels of ANXA1 in the cancer cells. Your doctor will know which cancer types this applies to.
have had standard treatment but it stopped working, you can’t have standard treatment or there isn’t a standard treatment available
have cancer that your doctor can measure on a scan or confirm cancer spread in a different way

You may be able to join part 2 if all of the following apply. You:

have pancreatic cancer that has grown into surrounding tissues or spread elsewhere in the body
are suitable to have MDX-124 in combination with chemotherapy
are suitable to have standard treatment with gemcitabine and nab-paclitaxel chemotherapy
are not suitable to have a combination of chemotherapy called FOLFIRINOX
have cancer that your doctor can measure on a scan

As well as the entry conditions above, all of the following must apply. You:

have satisfactory blood tests results
are fit and active but might not be able to do heavy physical work (performance status 0 or 1)
have a negative COVID-19 test result within 48 hours of your first dose of MDX-124
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
are at least 18 years old

Who can’t take part
You cannot join this trial if any of these main exclusion conditions apply.

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

have cancer of the head and neck or cervical cancer
have cancer that has spread to the brain or spinal cord or the membranes that surround them. Your doctor will know this.
have a problem with how your kidneys work
have moderate to severe side effects from chemotherapy or radiotherapy. This doesn’t apply if you have numbness or tingling in your hands or feet or you have hair loss.
take high doses of steroids within 14 days of starting trial treatment. You can take part if you take steroids to treat inflammation of the pituitary gland . Your doctor will know this.
had another cancer in the past 2 years. You can take part if you had non melanoma skin cancer that was successfully treated, carcinoma in situ of the cervix or ductal carcinoma in situ (DCIS ) of the breast that was treated with the aim to cure. You can also take part if you had another cancer and you finished treatment more than a year ago and there have been no signs of it since.
are having another cancer treatment that isn’t a conventional medical treatment (an alternative treatment) or you take traditional Chinese Medicine

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

have another medical condition that isn’t controlled with medication, an active infection that needs treatment or a temperature that is higher than 38.5 C on the day you are due to have MDX-124
have HIV or an active hepatitis B or hepatitis C infection. You can’t take part if you have hepatitis that isn’t active and you are taking medication to treat it.
have another medical condition or mental health problem that could affect you taking part

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

have had a live vaccination within 4 weeks of joining the trial. This doesn’t apply to approved COVID-19 vaccinations as they aren’t live.
are allergic to MDX-124 or anything it contains
have a problem with drugs or alcohol
are pregnant or breastfeeding

As well as the above there are specific 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.

Trial design

This is a phase 1 trial. It is taking place in the UK. The team need up to 74 people to take part.

The trial has 2 parts:

finding the best dose of MDX-124 to have (part 1)
looking at the best dose of MDX-124 in combination with chemotherapy for people with pancreatic cancer (part 2)

Part one
The team need about 44 people to join part one. The first few people taking part have a low dose of MDX-124. The next few people have a higher dose if they don’t have any serious side effects. And so on, until doctors find the best dose. This dose is one that helps the most and has the fewest side effects. Once they find this dose, they test it in a few more people.

Part two
The researchers need up to 30 people with pancreatic cancer to join this part. This part is not open to recruitment yet. It will open when they find the best dose in part 1. In this part you have MDX-124 alongside chemotherapy.

How you have treatment
Everyone has MDX-124 as a drip into a vein. It takes about 30 minutes each time.

Everyone has MDX-124 once every 2 weeks.

Those having gemcitabine and nab-paclitaxel have it once a week for 3 weeks. You then have a week when you don’t have chemotherapy.

You have treatment for about 7 months. You may have it for longer if treatment is still working and the side effects aren’t too bad. You stop treatment if your cancer gets worse. Your doctor will talk to you about this.

Samples for research
The researchers might ask you to give an extra tissue sample. 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:

measure ANXA1 in the body
to see what happens to MDX-124 in the body
see how well the treatment is working

You don’t have to agree to give the extra tissue sample if you don’t want to. It won’t affect you taking part in the rest of the trial. You don’t have to give all the blood samples for research either.

Hospital visits

You see the doctor and have tests before you can take part. These include:

blood tests
a physical examination
heart trace (ECG)
CT scan or MRI scan

You have all your treatment at the hospital. You have a number of hospital visits in the first week of treatment. After that you have regular blood tests and check ups with your doctor.

You have a CT or MRI scan at:

the end of month 2
the end of month 4 and then
once a month after that

You stop the trial scans if your cancer gets worse.

You see the trial team one month after you finish treatment. They then call you every 3 months or they may see you at a routine hospital appointment. This is to see how you are getting on.

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.

This is the first time people are having MDX-124. So there may be side effects we don’t know about yet.

MDX-124 can affect the immune system Open a glossary item . This may cause inflammation and other reactions in different parts of the body. For many people the inflammation and reactions are not too bad. For some people they can cause serious side effects.

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 drugs that work in a similar way to MDX-124 include:

high temperatures (fever)
chills
weakness
headaches
feeling or being sick
diarrhoea
low blood pressure
skin rash

Other possible side effects of drugs similar to MDX-124 include:

a reaction that can happen within 30 minutes to 2 hours of starting treatment with MDX-124. This is called an infusion reaction. Signs include wheezing, coughing, fever, chills, sweating, low blood pressure, rash and swelling under the skin.
the release of a chemical in the body called cytokines (cytokine release syndrome). This happens when your immune system responds to a drug more aggressively than it should. Symptoms can include fever, feeling sick, tiredness (fatigue) and body aches.
inflammation of the lung
kidney damage
liver damage

We have information about gemcitabine and nab-paclitaxel and its side effects.