A study looking at targeted drugs for solid cancers (BoB, Basket of Baskets)

Cancer type:

All cancer types

Status:

Open

Phase:

Phase 2

This study is looking at three different targeted drugs Open a glossary item for advanced solid cancers. A solid cancer is any cancer apart from cancers of the blood such as leukaemia and lymphoma.

More about this trial

Cancer cells have changes (mutations Open a glossary item ) in their genes . This means that they develop and grow in an uncontrolled way. There are many different changes that can happen in the genes of cancer cells. Not everyone’s cancer will have these changes or the same changes as someone else. This is so even when they are the same type of cancer.

Targeted cancer drugs Open a glossary item work by ‘targeting’ those differences that help a cancer cell to survive and grow. There are many different types of targeted drugs. Targeted drugs only work if the cancer has the particular change that the drug targets.

Doctors usually treat cancer based on where the cancer started in the body. In this study you have treatment based only on the changes in the genes, not where it started. This means people with different types of cancer that have the same change (mutation) in the cancer cells, could have the same treatment under this study.

There are 2 parts to the study:

I-Profiler
I-Basket

I-Profiler
This part looks at whether your cancer has any changes in the genes or proteins that match the action of one of the three targeted drugs tested in the trial. The researchers use your blood or tissue sample (biopsy Open a glossary item ) to look for the gene changes. If your cancer does have the gene changes then you might be able to go on to the second part.

I-Basket
In this part the team are looking at whether certain targeted drugs can help people with a cancer that has a particular change.

There are a number of targeted drugs that doctors can use. Researchers in this study are looking at three drugs:

atezolizumab
futibatinib
amivantamab

Atezolizumab is an immunotherapy drug. It works by helping the immune system Open a glossary item find and attack cancer cells.

Futibatinib is a cancer growth blocker. It works by blocking a protein called fibroblast growth factor receptor (FGFR). Cancer cells need FGFR to grow. By blocking FGFR, futibatinib stops the growth of the cancer.

Amivantamab is a type of bispecific antibody. It works by blocking two proteins, epidermal growth factor (EGF Open a glossary item ) and MET. Blocking these proteins may help stop cancer cells growing.

In the future the study team want to look at other targeted drugs. They want to find out how they might help people with particular and rare changes in the cancer. When they add further treatments we will update this summary.

The aims of this study are to find out:

how well targeted drugs work for the small number of people with a certain change in their cancer
how common particular changes in the cancer cells are
more about the side effects of these targeted drugs

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 solid cancer that has grown into the nearby tissue or has spread to another part of the body
have an area of cancer that the doctor can measure on a scan
are willing to have a fresh sample of cancer tissue (biopsy ) taken. That is if the study team can’t get a piece of the cancer tissue from a previous biopsy.
have satisfactory blood test results
are willing to take part in a clinical trial if the team say you are able to
are able to look after yourself but might not be able to do heavy physical work (performance status 0 or 1)
are at least 18 years old

If you have treatment as part of the study you must also be 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.

Who can’t take part

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

have cancer that has spread to the fluid or tissue surrounding the brain and spinal cord
have cancer that has spread to the brain or spinal cord. That is unless you have had treatment and the area of cancer spread has stayed the same or reduced in size at least 6 months after treatment.
have spinal cord compression that has not been treated with surgery, radiotherapy or both
have an illness that could affect you taking part such as an infection that needs treatment
have a heart problem that could affect you taking part
have HIV. You may be able to join if your viral load is undetectable.
have hepatitis B or hepatitis C
are not able to swallow capsules or tablets
have a problem with your digestive system that affects how well your body absorbs medicine
have any other medical condition, mental health problem or social problem that could affect you taking part

Trial design

This is a basket study. The team need 2,000 people to join the study.

There are 2 parts to the study. The first part is I-Profiler and the second part is I-Basket.

I-Profiler
You give blood samples and tissue samples (biopsies Open a glossary item ). The team ask for pieces of tissue samples that you had done previously.

You must be willing to have a fresh biopsy taken if they are not able to get this or there isn’t enough of the tissue samples.

They use these samples to look for gene changes (mutations Open a glossary item ) in the cancer cells. They may also look for proteins and other substances they can measure and target if they can’t find a gene change.

The team ask you to take part in I-Basket if there are certain changes in your cancer.

I-Basket
In I-Basket you have either atezolizumab, futibatinib or amivantamab.

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

Futibatinib is a tablet. You take it once a day for a maximum of 16 weeks.

You have amivantamab as a drip into a vein every 4 weeks. For the first 4 weeks, you have amivantamab once every week. From then on you have it once every two weeks.

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

Hospital visits

I-Profiler
You see the doctor before taking part. This is for a physical examination Open a glossary item and blood tests. You might also need to have a fresh cancer tissue sample taken. Your doctor will tell you if this is the case and will arrange it.

You see the doctor for the results. It will depend on these results as to whether you go on to the next part of the trial.

A member of the study team will contact you every 6 months by phone to see how you are. This is whether you go on to have treatment or not.

I-Basket
You see the doctor before starting treatment and at regular times during treatment. This is to see how you are and for blood tests.

Your doctor will tell you how often they want to see you.

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.

I-Profiler
You might have some bruising or bleeding from where they take the blood sample.

Side effects of having a tissue sample taken (biopsy) depend on where your cancer is. These can include:

pain
bruising and bleeding
low blood pressure
swelling
infection

Your doctor will talk to you about these side effects before you have the biopsy.

I-Basket

Atezolizumab can affect the immune system Open a glossary item . This may cause inflammation and other reactions in different parts of the body. For many people the inflammation and reactions are not too bad. For some people they can cause serious side effects.

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.

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.

The most common side effects of futibatinib include:

an increase in the amount of phosphate in the blood which can cause muscle cramps, numbness and tingling in the mouth
diarrhoea or constipation
feeling or being sick
tiredness and lack of energy (fatigue)
liver changes
hair loss
tummy (abdominal) pain
loss of appetite and taste changes
sore, dry mouth
a drop in red blood cells (anaemia) causing breathlessness and tiredness
dry skin
redness, swelling and blistering on the palm of the hands and soles of the feet
joint pain
weight loss
high amount of calcium in the blood

The most common side effects of amivantamab include:

skin problems such as a rash, cracked, dry, or scaly skin, blistering, crusting, irritation, itching, or reddening of the skin
nose bleeds
nerve pain and other nerve changes (neuropathy) chest pain or tightness
chills
cough
fever
flushing
headache
muscle or bone pain
feeling or being sick
redness or soreness around the fingernails and loosening of the fingernails
unsteadiness, being clumsy
weakness in the arms, hands, legs, or feet
changes to the heartbeat (palpitations)
diarrhoea
tummy (abdominal) pain
eye redness, irritation, or pain
tiredness (fatigue)