Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of LEQ506 for advanced cancer that has got worse despite other treatment
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called LEQ506 for advanced solid tumours. A solid tumour is any type of cancer apart from
Cells normally grow in a very orderly way. Chemical messages or signals tell them when to grow and when to stop. But in cancer cells the normal signalling system changes. So the cells keep on dividing. The cancer grows and may spread to other parts of the body.
LEQ506 is a new drug that blocks a specific protein and stops it sending growth signals. We know from research that blocking this protein affects the growth of several types of cancer cells. But this is the first time LEQ506 is being tested in people.
The people taking part have
- Find the best dose of LEQ506 to give
- Learn more about the side effects and what happens to LEQ506 in the body
- See how well it works for advanced cancer
Who can enter
You can enter the 1st part of this trial if you
- Have a
solid tumourthat has got worse despite having treatment and for which there is no other standard treatmentavailable
You can enter the 2nd part of this trial if the above applies to you and you
- Have a cancer that is likely to be affected by the specific protein that LEQ506 blocks, such as medulloblastoma that has come back or basal cell skin cancer that has spread
And for both parts of the trial you
- Have cancer that can be measured on a scan
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Have satisfactory blood test results
- Have recovered from the side effects of any other cancer treatment
- Are willing to use reliable contraception during the trial and for 3 months afterwards if there is any chance you or your partner could become pregnant
- Are at least 18 years old
You cannot enter either part of this trial if you
- Have cancer that started in your brain or spinal cord (central nervous system) apart from medulloblastoma that has come back
- Have cancer that has spread to your brain unless it has been removed with surgery, you don’t need to take steroids or medicine to prevent fits (seizures) and 2 scans done at least 3 months apart show it has not come back or got worse
- Have had anti cancer treatment in the last 2 weeks (in the last 4 weeks if you had a monoclonal antibody)
- Have had another experimental drug in the last 4 weeks, or longer if you could still have some of the drug in your body
- Have any problems affecting your
digestive system, including sickness or diarrhoea that cannot be controlled with medication
- Have had a heart attack in the last 3 months or have any other heart condition that is cause for concern – the trial doctors can advise you about this
- Are taking drugs that affect body substances called cytochrome P enzymes, drugs to lower cholesterol (statins), or certain other drugs - the trial team can advise you about this
- Are currently taking drugs that damp down your immune system and are not able to stop taking these before the study (it is important that you don’t stop taking this medication without talking to your doctor)
- Have any other serious medical condition that cannot be controlled with medication
- Are known to be HIV or hepatitis C positive
- Are pregnant or breastfeeding
This is a phase 1 study that will recruit up to 54 people in different countries. Everybody taking part will have LEQ506 as capsules that you swallow.
There are 2 parts to the trial. In part 1, doctors are looking for the highest safe dose of the trial drug. The first few patients taking part will have a low dose of LEQ506. If they don’t have any serious side effects, the next few patients will have a higher dose. And so on, until the researchers find the highest dose they can give safely. This is called a dose escalation study.
In part 2, the researchers want to learn more about the side effects. People joining the 2nd part of the trial will have the highest safe dose found in part 1.
If you join the trial during the dose escalation study, you start by having a single dose of LEQ506. The trial team monitor you closely for the next week. In the following week, you start taking LEQ506 capsules every day. If you join the 2nd part of the trial, you take the capsules every day from the start of treatment.
As long as you don’t have bad side effects, you can carry on having the trial treatment for as long as it helps you.
The trial team will take a number of blood samples throughout the trial and they will take a small
Depending on where in your body your cancer is, they may ask you to have 2 extra biopsies of your cancer. If you agree, you have one before you start treatment and another 3 weeks later. They will use the biopsies and some of the blood samples to look for biomarkers. These are substances in the body that doctors can measure to help them see how a disease is developing, or how a treatment is working. You don’t have to have these biopsies taken if you don’t want to. You can still take part in the trial.
As well as looking for biomarkers, the trial team will take a number of blood samples to learn more about what happens to LEQ506 in the body. This is called
You will see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Heart trace (
- Heart ultrasound (
- Blood and urine tests
- Chest X-ray
- CT scan or MRI scan
- A test to check how well your adrenal glands are working
You will be at the hospital all day the first time you have LEQ506. If you join the trial during the dose escalation study, you also have blood tests on each of the next 4 days.
The researchers call each 3 week period a cycle of treatment.
Everybody taking part goes to hospital at least once a week during the first 2 cycles of treatment. If you carry on taking LEQ506 for more than 2 cycles of treatment, you then go to hospital once every 3 weeks. The length of time you spend at hospital each time varies, but can be up to 9 hours. You have a CT scan after every 2 cycles of treatment.
You take the capsules at home at about the same time each day. The trial team will give you more information about how and when to take them.
After you finish treatment, you see the trial doctors again and have more tests and scans.
As LEQ506 is a new drug, there may be side effects we don’t know about yet. Possible side effects include
- Muscle cramps and muscle damage
- A build up of a substance caused myoglobin that can damage your kidneys
- Feeling or being sick
- Hair loss
- A skin rash if you are exposed to sunlight or other strong light
A number of times during the trial, you have a test to see how well your adrenal glands are working. This test can make you feel sick, anxious, sweaty or dizzy. It can also cause itchy or red skin, a fast or fluttering heart rate (palpitations) and flushing. This usually disappears within a few hours.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Mark Middleton
Experimental Cancer Medicine Centre (ECMC)