A trial looking at a drug called UCB4594 for cancer that has spread
Cancer type:
Status:
Phase:
This trial is looking at a drug called UCB4594 by itself and in combination with other treatments for 
that have spread (advanced cancer).
It is open to people whose treatment has stopped working and there is no available.
More about this trial
UCB4594 is a new drug. It is an immunotherapy drug. Researchers think that it might help the find and kill cancer cells. They know from that UCB4594 can do this. But they are not certain whether it could do so in people. So they need to find out how UCB4594 works for people with cancer.
Before they can find this out, they need to find the best dose of UCB4594 to give that doesn’t cause too many side effects. The best dose is one that works well and has the fewest side effects.
This trial is the first time researchers are using UCB4594 in people.
There are 2 parts in this trial. The:
dose escalation part - dose expansion part
The dose escalation part is to find the best dose of UCB4594. When the researchers find the best dose, they will do the dose expansion part.
The dose expansion part aims to find out more about how well UCB4594 works on its own and in combination with other cancer treatments.
At the moment only the dose escalation part is open to recruitment. We will update this summary when the dose expansion part opens to recruitment.
The main aims of the trial are to find out:
- the best dose of UCB4594 to give
- more about the side effects of UCB4594 and how doctors can help to relieve these side effects
- what happens to UCB4594 in the body and how it affects the cancer cells
- how well UCB4594 works and if it shrinks the cancer or stops it growing
Who can enter
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.
Who can take part
You may be able to join this trial if you have one of the following cancers that has spread:
- a head and neck cancer that is a
squamous cell cancer - non small cell lung cancer
- bowel (colorectal) cancer
- triple negative breast cancer
- renal cell cancer that is clear cell only
- cancer of the food pipe (oesophageal cancer) apart from
gastrointestinal stromal tumour (GIST) - cervical cancer
- ovarian cancer
- pancreatic cancer
And all of the following apply.
- You have a sample of tissue (
biopsy ) taken recently that is suitable for the trial team to use. If this is not the case you are willing to have a fresh biopsy taken. - The standard treatment for your cancer spread has stopped working or there is no standard treatment or you do not want the standard treatment.
- You have an area of cancer that the doctor can measure.
- You are up and about, can look after yourself but might not be able to do heavy physical work (performance status 0 or 1).
- You have satisfactory blood test results.
- You are willing to use reliable contraception during treatment and for a while after if there is any chance you or your partner could become pregnant.
- You are at least 18 years old. You might be able to join if you are 16 or 17 years old but you will need to ask your doctor.
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
- have treatment for your cancer within 4 weeks of starting the trial treatment. This is apart from radiotherapy to relieve symptoms. And
hormone treatment that is not to do with the cancer. - have had an experimental drug as part of another clinical trial within 4 weeks of starting the trial treatment
- are taking part, or plan to take part in another clinical trial while taking part in this clinical trial. This is apart from an observational trial or a clinical trial that is not using an experimental drug. Ask your doctor about this.
- have ongoing moderate to severe side effects from previous treatment. This is apart from hair loss, moderate damage to the nerves of the hand and feet (peripheral neuropathy) and hormonal side effects that are controlled with
hormone replacement therapy (HRT) . - have cancer that has spread to the brain that is getting worse or has not been treated. You can join if you have cancer spread to the brain that has been treated as long as it is stable, you have not had a seizure (fit) or needed steroids within 2 weeks of starting the trial treatment.
- have cancer that has spread to the tissue surrounding the brain
- have an increased risk of your cancer symptoms becoming worse after starting treatment (
tumour flare ). Your doctor will check for this and let you know. - have, or had, another cancer. This is apart from successfully treated
carcinoma in situ of the cervix and non melanoma skin cancer . You can take part if you had a cancer, had treatment with the aim to cure, there has not been any sign of it for 3 or more years and there is a very small risk of it coming back. - had stopped taking
immunotherapy treatment due to bad side effects. You can join if you were taking 2 different immunotherapies and you only needed to stop taking one of them. Talk to your doctor about this. - had severe side effects after having a
monoclonal antibody or similar drugs - have already had treatment with a drug that targets HLA-G, ILT2 or ILT4. Your doctor will know this.
Medical conditions
You cannot join this trial if any of these apply. You:
- had surgery and have ongoing complications from the surgery
- have hepatitis B, hepatitis C, HIV, any other serious infection or an infection that is not controlled
- have an
autoimmune disease apart from certain ones which your doctor will know about - have had an
organ transplant - have had a donor stem cell or bone marrow transplant (
allogeneic transplant ) - are taking high dose or increasing doses of
steroids , or other drugs that damp down the immune system. This is apart from creams, drops, sprays, injections that are not regular and steroids to treat inflammation of the pituitary gland that is caused by immunotherapy. - have major
lung problems such as inflammation - have problems with bleeding
- have
heart problems such as heart attack or heart failure - have any other medical condition or mental health problem that could affect you taking part
Other
You cannot join this trial if any of these apply. You:
- are allergic or sensitive to the treatments or any of their ingredients used in this trial
- have a
live vaccine within 28 days of starting the trial treatment. The COVID-19 and seasonal flu vaccines are not live vaccines. - are pregnant or breastfeeding
Trial design
This is a phase 1/2 trial. The team need up to 167 people to take part. There are 2 parts in the trial. The:
dose escalation part- dose expansion part, not yet open
Dose escalation
The first few people have a small dose of UCB4594. If they don’t have bad side effects the next few have a higher dose. And so on until they find the best dose to give. This is the dose escalation part of the trial.
When the team find the best dose to use, they will look at how well it works. This is the dose expansion part of the trial.
People in the dose escalation part will continue having the same dose of UCB4594.
Dose expansion
In the dose expansion part, you might have UCB4594 by itself or in combination with another cancer treatment. Your doctor will tell you about this.
How you have UCB4594
You have UCB4594 as a drip into a vein (infusion). You have UCB4594 once every 3 weeks. Each 3 week period is a . You have UCB4594 over 60 minutes for the first 2 cycles of treatment. For the rest of the cycles, you have UCB4594 over 30 minutes.
You might have a reaction to the UCB4594 while having the infusion. Your nurse will watch you closely for any signs of a reaction. Tell the nurse if you feel unwell during the infusion. If you do have a reaction they might stop, or slow down, the infusion and give you some medication. For the next infusions, your doctor might give you medication before each of the following treatments with UCB4594. Or you might have the UCB4594 infusion over a longer period of time. Your doctor will talk to you about this if needed.
You stay in hospital for at least 24 hours after your 1st treatment. And for 8 hours after your 2nd treatment and an hour after your 3rd treatment. This is so the healthcare team can watch you closely and make sure you are okay.
You can have UCB4594 for up to about 2 years as long as it is helping and the side effects aren’t too bad.
Samples for research
The team take blood samples. Where possible they will take these samples when you have blood taken as part of your routine care.
They will use these samples to:
- find out what happens to UCB4594 in the body
- find out how UCB4594 affects the body
- find out how the
immune system responds to UCB4594 - look for small pieces of cancer DNA in the blood (
ctDNA )
The team will ask for 1 or 2 tissue samples (). Whether they take 1 or 2 depends on when you join the trial. Your doctor or nurse will tell you how many they want to take and when.
They will use these samples to find out:
- more about the cancer and how it grows
- why UCB4594 might help some people more than others
You must agree to have the blood and tissue samples to take part in the trial.
Hospital visits
You see the doctor to have tests before taking part. These tests include:
- a
physical examination - blood tests
- heart trace (ECG)
- heart scan (ECHO)
- eye tests
breathing tests (lung function tests) - urine test
- CT scan or MRI scan
You see the doctor while having treatment. This is to see how you are and for some tests.
Follow up
You see the doctor every month after stopping treatment for 6 months. At 1 month and 3 months you have the same tests you had at the start. The 2 month appointment may be a phone call from the doctor.
At each appointment the doctor will ask how you are and whether you have any side effects.
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.
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UBC4594 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. |
This is the first time researchers are using UCB4594 to treat people with cancer. So there may be side effects we don’t know about yet. The information about the side effects are from .
These side effects can include:
- a reaction while having UCB4594. The symptoms include high temperature (fever), chills, flushing, itching, rash or hives, swelling, feeling or being sick and shortness of breath. Tell your nurse straight away if you have any of these symptoms.
- your body releasing a large amount of a substance called
cytokines . This is called cytokine release syndrome. Symptoms include a high temperature (fever), headache, skin rash, dizziness due to low blood pressure, breathlessness due to low blood oxygen levels and a fast heartbeat. It is serious and can be life threatening. Tell your doctor as soon as possible if you have any symptoms so they can treat it. - inflammation in different parts of the body
- pain where the cancer is
- skin rashes
- an allergic reaction. The symptoms include high temperature (fever), chills, flushing, itching, rash or hives, feeling or being sick and shortness of breath.
Your doctor will talk to you about the possible side effects of the treatments used in this trial and will answer any questions you may have before you agree to take part.
Location
Recruitment start:
Recruitment end:
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.
Chief Investigator
Professor Fiona Thistlewaite
Supported by
Cancer Research UK
Centre for Drug Development
UCB Biopharma SRL
Other information
This is Cancer Research UK trial number CRUKD/24/001.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
