A trial of inobrodib for some types of blood cancer
Cancer type:
Status:
Phase:
This trial is for people with blood cancer that has come back or is getting worse despite treatment.
It is for people with one of the following types of blood cancer:
- B cell or T cell non-Hodgkin lymphoma (NHL)
- myeloma
- acute myeloid leukaemia (AML)
- high risk myelodysplastic syndrome (MDS) – this means the MDS has a high risk of developing into leukaemia
More about this trial
Doctors are looking for new treatments for people with blood cancer that has come back or whose treatment has stopped working. In this trial they are looking at a new drug called inobrodib (CCS1477). It is a targeted drug.
Cancers need certain proteins to grow. These include 2 proteins called p300 and CBP. Inobrodib blocks the action of these proteins. This stops the signals the blood cancer cells use to divide and grow. Researchers hope that inobrodib will slow the growth of blood cancer. But they aren’t sure so want to find out more.
We also know from research that having inobrodib with the following drugs might improve treatment:
- azacitidine or venetoclax for acute myeloid leukaemia
- pomalidomide and dexamethasone for myeloma
- venetoclax for lymphoma
These are all standard treatments for these cancer types. Everyone in the trial will have inobrodib. Depending on your cancer type, you might also have a drug or combination of treatment from the list above.
There are 6 separate parts in the trial. The part you join depends on the type of blood cancer you have and when you join the trial.
The main aims of the trial are to:
- find the best dose of inobrodib
- find out what happens to inobrodib in the body
- learn about the side effects
- find out how well treatment works
Who can enter
The following bullet points list 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.
Please note, there are several treatment groups so the entry conditions for this trial are complex. Each group has specific entry conditions and we haven’t listed them all.
Who can take part
You may be able to join this trial if you have 1 of the following types of blood cancer that have come back or treatment has stopped working:
- B cell non-Hodgkin lymphoma
- T cell non-Hodgkin lymphoma
- myeloma
- acute myeloid leukaemia (AML)
- high risk myelodysplastic syndrome (MDS)
As well as the above the following must also apply. You:
- have had at least 2 different
standard treatments 
for blood cancer in the past. You might be able to take part if there are no standard treatments available or you wouldn’t be suitable to have them. - 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
- are willing to use reliable contraception during treatment and for 3 months afterwards if you or your partner could become pregnant. You are willing to use a condom during treatment and for 1 week after if you are a man and can pass your sperm to another person.
- are at least 18 years old
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
- have lymphoma in the brain or spinal cord, cancer that has spread to the tissue that covers the brain or spinal cord or a condition called
spinal cord compression - have had chemotherapy, an anti cancer drug, an
immunotherapy or an experimental treatment in the last 14 days or a treatment that hasn’t completely cleared your body - have had radiotherapy to more than 30% of the bone marrow within 4 weeks of trial treatment or in the last 2 weeks before you start treatment if you had radiotherapy to help with symptoms (
palliative radiotherapy) - have had another cancer in the past apart from
non melanoma skin cancer or carcinoma insitu (CIS ) that has been successfully treated. Or you had treatment for another cancer with the aim to cure it and there have been no signs of it for at least 6 months.
Medical conditions
You cannot join this trial if any of these apply. You:
- have had major surgery within 4 weeks of starting trial treatment
- take more than 10mg of prednisolone each day or a similar drug and dose and you have had this within 2 weeks of starting trial treatment
- have side effects from past treatments that aren’t getting better unless they are mild apart from hair loss or moderate numbness and tingling in the hands or feet (
peripheral neuropathy ) - have a heart or lung condition that is severe or isn’t well controlled with medication. For example, you have congestive heart failure that is causing problems, high blood pressure or angina that isn’t well controlled with medication
- have a heart condition called a QT prolongation
- take medication for high cholesterol (statins) that you can’t stop taking. You should never stop taking a medication without first talking to your doctor.
- have an active infection including hepatitis B, hepatitis C or HIV
- have a medical condition that means you are more likely to have a bleed
- have taken any medication that blocks an enzyme called CYP3A4 in the 4 weeks before joining this trial
- have taken herbal medicine in the 7 days before starting trial treatment or you have taken St John’s wort in the last month
- have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial
Other
You cannot join this trial if any of these apply. You:
- have a severe allergy to inobrodib or anything it contains
- are pregnant or breastfeeding
As well as the above there are specific entry conditions 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 1/2 trial. The researchers need 90 people from the UK to take part.
There are 6 parts to this trial. Parts A and B are looking at the best dose of CCS1477 to have. These are dose escalation studies.
Parts C, D, E and F are testing this dose in more people. These are dose expansion studies.
Dose escalation groups
| Part A | finding the best dose of inobrodib in people with NHL and myeloma |
| Part B | finding the best dose of inobrodib in people with AML or high risk MDS |
Dose expansion groups
| Part C | testing the best dose of inobrodib in more people with NHL |
| Part D | testing the best dose of inobrodib in more people with myeloma |
| Part E | testing the best dose of inobrodib in more people with AML |
Part F is testing the best dose of inobrodib in more people with higher risk MDS.
Inobrodib is a capsule. You take them in the morning with a glass of water. You must fast (water only) for at least 2 hours before taking your trial medication and for at least 1 hour after.
The team tell you how many capsules to take and how often to take them.
Everyone has treatment for as long as it is working and the side effects aren’t too bad.
Part A
This group is for people who have NHL or myeloma. The first few people have a low dose of inobrodib. If they don’t have any side effects, the next few people have a higher dose. And so on, until they find the best dose to give.
Part B
This group is for people with AML or high risk MDS. The first few people have a low dose of inobrodib. If they don’t have any side effects, the next few people have a higher dose. And so on, until they find the best dose to give.
Part C
This group is for people with NHL. When they find the best dose in part A then part C can open. The team test this dose in 30 people with NHL.
Part D
This group is for people with myeloma. When they find the best dose in part A then part D can open.
In this group, you have one of the following:
- inobrodib in combination with pomalidomide and dexamethasone
- inobrodib in combination with dexamethasone
- inobrodib in combination with pomalidomide
Pomalidomide is a tablet. You take them once a day every day for 3 weeks. You then don’t take them for a week. You then start the next Each cycle lasts 4 weeks.
Dexamethasone is a tablet. You take them once a week.
Part E
This group is for people with AML. When they find the best dose in part B then part E can open.
In this group you might have inobrodib in combination with azacitidine alone or together with venetoclax.
You have azacitidine as an injection under the skin. The team can tell you how often you will have this.
Venetoclax is a tablet. You take it once a day, every day.
Part F
This group is for people who have higher risk MDS. When they find the best dose in part B, then part F can open.
In this group you have one of the following:
- inobrodib in combination with azacitidine
- inobrodib, azacitidine and venetoclax
- inobrodib and venetoclax
You have azacitidine as an injection under the skin. The team can tell you how often you will have this.
Venetoclax is a tablet. You take it once a day every day for 2 weeks. You then don’t take it for a week. You then start the next cycle of treatment. Each cycle lasts for 4 weeks.
Samples for research
The team may ask for a sample of tissue () from when you were first diagnosed. They also collect some samples if you have bone marrow tests as part of the trial.
You give some extra blood samples. Where possible you give these at the same time as your routine blood samples.
The researchers plan to use the samples to:
- look for
biomarkers - find out what happens to the drug in the body (
pharmacokinetics ). - find out more about how treatment works
Hospital visits
You see a doctor and have some tests before you join the trial. Everyone taking part has the following:
- physical examination
- heart trace (
ECG ) - blood tests
- urine tests
People with AML, MDS or myeloma also have a bone marrow test.
People with myeloma have scans to look for changes that myeloma can cause in the skeleton or soft tissue. These include 1 of the following:
- PET-CT
- CT scan of your whole body
- MRI scan of your whole body
- a series of x-rays (skeletal survey)
People with NHL also have:
- CT scan or MRI scan
- PET-CT scan
They might also need to have a bone marrow test.
During treatment
During treatment everyone has a check up with the trial doctor at least:
- once a week in the first month of treatment
- once or twice a month after that
In the first month of treatment you might need to stay overnight at the hospital or a nearby hotel and return to the hospital in the morning.
People with AML or MDS have a bone marrow test every 2 months for 6 months. After that your doctor decides how often to repeat these tests.
People with myeloma might need to have more bone marrow tests and skeletal surveys during treatment. The team will let you know when and if you need to have these.
People with NHL have a scan:
- at 8 weeks
- every 3 months after that until the lymphoma gets worse
The type of scan you have is the same as you had at the start of the trial. So, it might be a CT scan, MRI scan or PET-CT scan.
Follow up
You see the trial team one month after you stop treatment. They might contact you at home to follow up on any side effects you are having. After that, they contact your GP 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.
Inobrodib is a new drug and only a few people have had it. So there might be some side effects that we don’t know about yet.
So far, the possible side effects of inobrodib include:
- tiredness
- fever
- a drop in the number of blood cells causing an increased risk of bruising or bleeding, breathlessness, tiredness and looking pale
- changes to levels of salt in the body
- changes in blood tests that show how the liver is working
- kidney changes
- feeling or being sick
- loss of appetite
- low levels of testosterone in the body in men. This can cause you to lose interest in having sex and affect your ability to get and keep an erection.
- high levels of sugar in the blood
- diarrhoea and tummy pain
The trial doctor tells you about all the possible side effects of treatment.
Inobrodib can make you more sensitive to sunlight. You should avoid going out in the sun for long periods during treatment and for 4 weeks afterwards. You should cover up and try to stay in the shade. The team advise you to apply a sunscreen that is SPF30 or higher.
You should not take any herbal medication during treatment. Nor should you have large amounts of grapefruit or Seville oranges. These can interfere with how treatment works.
We have information about the following treatments and their side effects:
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 Tim Somervaille
Supported by
CellCentric Ltd
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
