A study of a drug called alomfilimab for head and neck cancers that have spread

Cancer type:

Head and neck cancers

Secondary cancers

Status:

Open

Phase:

Phase 1/2

This study is looking at new drug called alomfilimab (KY1044). It is looking at giving alomfilimab by itself and in combination with atezolizumab for advanced cancers Open a glossary item of the head and neck.

It is open to people with a head and neck cancer that is a squamous cell Open a glossary item type.

More about this trial

Atezolizumab is an immunotherapy Open a glossary item . It works by blocking a protein that stops the immune system from working properly and attacking cancer cells. Blocking this protein helps the immune system to find and kill the cancer cells. Doctors already use atezolizumab to treat many different types of cancer.

Alomfilimab is also an immunotherapy. It works in a similar way to atezolizumab but alomfilimab blocks a different protein.

Researchers think that alomfilimab by itself or with atezolizumab might help people with cancer that has spread.

The team have found the best dose of alomfilimab to give by itself and also in combination with atezolizumab. They now want to find out how well these treatments work.

In this study some people will have alomfilimab. And some people will have alomfilimab with atezolizumab.

The aims of this study are to find out:

how well alomfilimab works by itself and in combination with atezolizumab
more about the side effects of these treatments
what happens to these treatments in the body
how the body affects these treatments

Who can enter

The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study 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 study if all of the following apply. You:

have a head and neck cancer that is a squamous cell cancer and has spread
have had all the available treatment for your cancer or there is no standard treatment
are able to have a tissue sample (biopsy ) taken and you are willing to have biopsies taken during the study
have an area of cancer the doctor can measure
can look after yourself but might not be able to do heavy physical work (performance status 0 or 1)
have satisfactory blood test results
are willing to use contraception during treatment and for a time after. That is if there is any chance you or your partner could become pregnant.
are at least 18 years old

Who can’t take part

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

have cancer spread to the brain or spinal cord. This is unless it has been treated, is stable and you have not had steroids for at least the past 2 weeks.
have antibodies that stop atezolizumab from working. You may have them if you have had atezolizumab before.
had a type of targeted drug called PD-1 or PD-L1 and you stopped treatment due to side effects
have had certain types of cancer drugs recently. For tyrosine kinase inhibitors (TKI) or chemotherapy you can’t join the trial if you have had them within 2 weeks of starting treatment. And for mitomycin C, nitrosoureas and immunotherapies it is 4 weeks.
have had an immunotherapy with another targeted treatment that stimulates the T cells or is a checkpoint inhibitor . Your doctor will know if you have had any of these.
have moderate to severe ongoing side effects from any previous treatment. This is apart from hair loss, peripheral neuropathy and hearing problems.
have another cancer unless it was treated with the aim to cure and there hasn’t been any sign of it for the past 2 years. You can also join if you had successfully treated non melanoma skin cancer or a carcinoma in situ .
have radiotherapy within 2 weeks of starting treatment. Unless it is to relieve symptoms such as pain and is in a small area.
have GM-CSF or a similar drug that helps the bone marrow make blood cells 2 weeks or less before starting treatment. If it is a drug that stimulates erythropoietin you must have started it at least 2 weeks before starting treatment and be on a stable dose.
have an experimental drug or use a device as part of a clinical trial within 4 weeks of starting treatment

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

have heart problems such as congestive heart failure
have high blood pressure that isn’t controlled
have HIV, hepatitis B or hepatitis C
have any other serious infection within 4 weeks of starting treatment
have an autoimmune disease apart from vitiligo or asthma that is controlled using inhalers
have or had inflammation of the lungs caused by drugs
are taking herbal preparations such as St John’s Wort, gingko balboa or ginseng within a certain time before starting treatment and after treatment is finished. Your doctor will know more about this.
are taking warfarin or a similar drug to stop blood clotting. This is unless you can change to low molecular weight heparin. Ask your doctor about this.
have major surgery within 2 weeks of starting treatment

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

are allergic or very sensitive to any of the treatments or their ingredients
have a live vaccine within 4 weeks of starting treatment. The COVID-19 vaccines are not live vaccines.
are pregnant or breastfeeding

Trial design

This is an international phase 1/2 study. The study team need 412 people worldwide to join.

There are 2 groups in this study those who have:

alomfilimab by itself
alomfilimab with atezolizumab

Your doctor will tell you which group you are in.

You have alomfilimab and atezolizumab as a drip into a vein. You have them every 3 weeks. Each 3 week period is a cycle of treatment Open a glossary item .

You continue treatment as long as it is helping and the side effects aren’t too bad.

Samples for research
You give some blood samples and tissue samples (biopsies Open a glossary item ) during the study. Where possible the team take these when you have them taken as part of your routine care.

Researchers use these samples to look for substances in the blood and tissue (biomarkers Open a glossary item ) that might tell them:

how well treatment is working
why some get side effects and some don’t

You don’t have to agree to do this.

Hospital visits

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

a physical examination
blood tests
heart trace (ECG )
a test to show how much oxygen is in the blood (oxygen saturation test)
urine test
CT scan or an MRI scan
tissue sample (biopsy)

You see the doctor for blood tests and to see how you are:

at regular times during treatment
at the end of treatment
then every 3 months

You have a scan every 8 weeks for 16 weeks and then every 3 months for 4 years. This is if you are still having treatment or until your cancer starts to grow again.

Side effects

The study 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.

Alomfilimab and atezolizumab can affect the immune system. They may cause inflammation in different parts of the body. This can cause serious side effects. They could happen during treatment, or some 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.

If you have any of these side effects tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy.

Alomfilimab is a new drug and there might be side effects we don’t know about yet. The most common side effects we do know about are:

reactions where alomfilimab goes into the vein causing the area to go red, become sore and swollen
loss of appetite
tiredness (fatigue)
diarrhoea
feeling sick
skin rash
chills

Some people have had alomfilimab with atezolizumab. There might be side effects from this combination we don’t know about yet. The most common side effects we do know about are: