A trial of LJM716 with trastuzumab for breast or stomach cancer that is HER2 positive

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

Cancer type:

Breast cancer

Oesophageal cancer

Stomach cancer

Status:

Closed

Phase:

Phase 1

This trial is looking at a new drug called LJM716 alongside trastuzumab (Herceptin) for HER2 positive cancer. It is for people who have breast cancer, stomach cancer or cancer where the food pipe (oesophagus) meets the stomach (gastro oesophageal junction cancer) that has spread to another part of the body.

Cancers with large amounts of a protein called HER2 Open a glossary item are called HER2 positive cancers. Doctors can treat HER2 positive cancer with drugs such as trastuzumab (also known as Herceptin) which target the HER2 protein.

In this trial, researchers are looking at a drug called LJM716 alongside trastuzumab. LJM716 is a type of biological therapy called a monoclonal antibody. It stops signals that cancer cells use to divide and grow.

The aims of the trial are to

Find the highest dose of LJM716 you can have safely
Learn more about the side effects and what happens to the drug in your body
See if it helps people with HER2 positive cancer

Who can enter

You may be able to enter this trial if

You have breast cancer, stomach cancer or cancer where the food pipe (oesophagus) meets the stomach (gastro oesophageal junction cancer)
Your cancer cannot be removed with surgery or has spread to another part of your body
Your cancer has large amounts of the HER2 protein (HER2 positive)
You have already had at least one type of treatment that included trastuzumab (Herceptin)
You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
You have recovered from the side effects of earlier cancer treatment (apart from hair loss) – you can take part if you have nerve damage (peripheral neuropathy) as long as it is only mild
You have satisfactory blood test results
You are at least 18 years old
You are willing to use reliable contraception during the trial and for at least 3 months afterwards if there is any chance you could become pregnant

As well as the above

If you have breast cancer, you must have had between 1 and 3 treatments that target HER2 and your cancer got worse during the most recent treatment, which must have included either trastuzumab or a drug called lapatinib.
If you have stomach cancer, you must have had 1 or 2 treatments that target HER2 and your cancer got worse during the most recent treatment, which must have included trastuzumab.

People joining the 2nd part of the trial must have cancer that can be seen on a CT scan, an MRI scan or a photograph of the skin and measures at least 1cm across.

You cannot enter this trial if

You have cancer that has spread to your brain and hasn’t been treated or is causing symptoms – you can take part if cancer spread to your brain has been treated with surgery or radiotherapy, is not getting worse and if you take steroids, the dose has been the same for at least 4 weeks
You have any other cancer that needs treatment
There isn’t an available sample of your cancer that was removed in the past
You have already had treatment that targets a protein called HER3
You have had any other anti cancer drugs (apart from trastuzumab) in the last 4 weeks (6 weeks if you had mitomycin C or a drug called a nitrosourea ), or earlier if there is any chance some of the drug could still be in your body
You have had major surgery in the last 4 weeks or haven’t fully recovered from any type of surgery
You have had radiotherapy in the last 2 weeks unless it was radiotherapy to a small area of your body to treat symptoms from cancer spread to your bones
You have an autoimmune disease that needs treatment other than a low dose of a steroid called prednisolone
You have had a bad reaction to a drug made in a similar way to the trial drug – the trial team can advise you about this
You have an infection that has needed treatment in the last 10 days
You have certain heart problems – the trial team can advise you about this
You have any other serious medical condition or mental health problem that the trial team think would make it unsuitable for you to take part
You are known to have HIV, hepatitis B or hepatitis C
You are pregnant or breastfeeding

Trial design

This phase 1 trial will recruit at least 55 people. Everybody taking part has trastuzumab and LJM716. You have both drugs through a drip into a vein once a week.

The trial is in 2 parts. In the 1st part, the researchers want to find the highest safe dose of LJM716. The first few patients taking part will have a low dose of the drug. If they don’t have any serious side effects, the next few patients will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study.

In the 2nd part of the trial, the researchers want to learn more about LJM716 and whether it can stop or slow down the growth of HER2 positive cancers. Everybody joining this part of the trial has the highest safe dose found in part 1.

As long as you don’t have bad side effects, you can carry on having the trial treatment for as long as it is helping you.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

Physical examination
Blood tests
Urine test
Heart trace (ECG )
Heart scan (echocardiogram ) or MUGA scan
CT scan or MRI scan

If your cancer has spread to your skin, the trial team will take a photograph. This will not include your face and it won’t be possible to identify you from the photo.

The researchers will get a sample of your cancer removed when you had surgery or a biopsy Open a glossary item .

If you join the 1st part of the trial, they may ask you to have another biopsy before you start having LJM716. But you don’t have to have this biopsy if you don’t want to. You can still take part in the trial.

If you join the 2nd part of the trial, you must be willing to have another biopsy before you start having LJM716.

You go to hospital

Between 7 and 9 times in the first 4 weeks of treatment
4 times in the next 4 weeks
Between 7 and 9 times in the following 4 weeks
Once a week after that

You have regular blood tests and more heart traces throughout the treatment. You have a CT or MRI scan every 8 weeks. And if you have cancer spread to your skin, the trial team will also take photographs every 8 weeks.

People in the 2nd part of the trial may be asked to have 2 more biopsies. But these are optional. If you don’t want to have more biopsies, you can still take part in the trial.

Most hospital visits will last between 1 and 4 hours. A couple of visits early in your treatment will last 11 or 12 hours and you may need to stay in hospital overnight.

When you finish the treatment, the trial team will contact you a month later to see how you are.

If you stop the treatment for any reason other than your cancer getting worse, you continue to have a CT or MRI scan every 2 months until your cancer does start to get worse.

Side effects

As LJM716 is a new drug, there may be side effects we don’t know about yet. The possible side effects include

A reaction to the drug causing symptoms such as high temperature (fever), chills, feeling or being sick, headache, dizziness, difficulty in breathing, drop in blood pressure, rash, and lack of muscle strength
Tiredness (fatigue)
Rash
Sore mouth
Diarrhoea
Feeling or being sick
Loss of appetite
Low levels of potassium and magnesium in the blood

To try to prevent a reaction, you have the LJM716 slowly over at least 2 hours. And you may have other medication such as paracetamol, an antihistamine Open a glossary item drug and steroids to reduce the risk of a reaction.

We have more information about the side effects of trastuzumab.

It is possible that the side effects of trastuzumab may be different when you have it at the same time as LJM716. The trial team will talk to you about all the possible side effects of the drugs before you agree to take part.