A study of INCB099318 for advanced solid cancers

Cancer type:

All cancer types

Status:

Open

Phase:

Phase 1

This study is looking at a drug called INCB099318 for advanced solid cancers Open a glossary item. A solid cancer is any cancer apart from blood cancers such as leukaemia and lymphoma.

The study is open to people who:

  • have cancer that has got worse after having all available treatment or
  • can’t have the standard treatment Open a glossary item for their cancer

More about this trial

INCB099318 is a targeted drug Open a glossary item called an immunotherapy. It works by blocking a protein called PD-L1. Blocking PD-L1 can help the immune system Open a glossary item fight cancer. 

To find out if INCB099318 can help fight cancer researchers need to do a large clinical trial Open a glossary item. Before doing this they need to find out what is the best dose for people to take. The best dose is one that helps the most and has the fewest side effects.

The aims of this study are to find:

  • what is the best dose of INCB099318
  • out more about the side effects
  • out how acceptable it is

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 Open a glossary item that has spread from where it started 
  • have an area of cancer that the doctor can measure 
  • have cancer that cannot be treated with the aim to cure
  • have had all the available treatment for your cancer and it continued to get worse
  • are willing to have a small piece of tissue (biopsy Open a glossary item) taken from your cancer 
  • can look after yourself but may not be able to do heavy physical work (performance status 0 or 1)
  • have satisfactory blood test results
  • must be willing to use contraception during the study and for a certain time after if there is any chance you or your partner could become pregnant
  • are at least 18 years old

There are other parts to this study you might be able to join. Your doctor will know if you can. 

Who can’t take part

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

  • can have the standard treatment Open a glossary item for your cancer  
  • have cancer spread to the brain or spinal cord. You might be able to join if it has been treated, is stable and you don’t need steroids for at least 1 week before study treatment. 
  • have another cancer that needs treatment or is getting worse. This is apart from successfully treated non melanoma skin cancer Open a glossary item, in situ cancer Open a glossary item of the cervix and early stage Open a glossary item endometrial cancer. 
  • still have side effects from previous treatment. This is apart from hair loss. And some other side effects that your doctor will know about. 
  • have had other cancer treatment including experimental drugs within a certain time of starting study treatment. You doctor will know what the time is for which drugs. 

You cannot join part 1 of the study if you have cancer spread to a fifth (20%) or more of your liver. Your doctor can tell you more about this. 

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

  • have had chest pain (angina) or a heart attack within 6 months of starting treatment. Or you have another heart problem Open a glossary item.
  • have an autoimmune disease Open a glossary item that needed systemic treatment Open a glossary item in the past 2 years. This is apart from certain autoimmune diseases. Your doctor will know which ones. 
  • have an immune system  Open a glossary itemthat isn’t working very well. You are taking medication such as steroids that affect how well your immune system works.
  • have a disease of the lung tissue. You have inflammation of the lung that is active and not infectious.
  • have had a targeted drug called a anti PD-L1. Your doctor will know if you have had this. 
  • have had more than 1 immunotherapy Open a glossary item treatment before
  • are taking medication that affects the CYP enzymes. You might be able to join if you can stop taking these before starting the study treatment. 
  • have HIV, active hepatitis B or hepatitis C or any active infection needing treatment
  • had an antibiotic within 28 days of starting the study treatment
  • have a problem with your digestive system Open a glossary item that affects how well your body can absorb medication 
  • have any other medical condition or mental health problems that could affect you taking part

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

  • take probiotics just before going into the study or during the study
  • have a live vaccine Open a glossary item within 30 days of starting study treatment
  • are allergic to the treatment or any of its ingredients
  • are pregnant or breastfeeding

Trial design

This is a phase 1 study. The team plan to have up to 140 people take part with about 20 people in the UK. 

The study is in 2 parts.  

In part 1 the team want to find the best dose of INCB099318. This is one that helps the most and has the fewest side effects. 

The first few people in this part take a small dose of INCB099318. If that goes well then the next people take a higher dose. And so on until the team find the best dose of INCB099318. 

Part 2 starts after the team find the best dose of INCB099318 to take. 

INCB099318 is a tablet. You take it with a glass of water. 

What dose you have and how often you have it depends on when you join the study. You doctor will tell what dose to take and how often you take it.

You can have INCB099318 for up to 2 years if it is helping and the side effects aren’t too bad. 

Samples for research
You have a sample of tissue (biopsy) taken before you start treatment and then between week 2 and week 3 of treatment. You must agree to these to take part. 

The team might ask to take another biopsy during treatment. This biopsy is optional. You don’t have to agree to it. 

You give several blood samples during the study. Your doctor will tell you more about how often these are. 

Researchers use the tissue and blood samples to find out:

  • how well INCB099318 is helping
  • what happens to INCB099318 in the body
  • how INCB099318 affects the body

Hospital visits

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

  • a physical examination Open a glossary item 
  • blood tests
  • heart trace (ECG Open a glossary item)
  • urine test
  • CT scan or MRI scan

During treatment you see the doctor regularly to see if you have any side effects and for:

  • a physical examination
  • blood tests
  • urine test
  • heart trace

You have a CT scan or MRI scan every 8 weeks for a year and then every 3 months while taking INCB099318. 

If you stop taking INCB099318 and your cancer has not got worse you have the scan:

  • every 8 weeks until the cancer does get worse
  • or you start another cancer treatment

After a year you then have the scan every 3 months.  

About a month after stopping INCB099318 you see the doctor to see if you have any side effects and for:

  • a physical examination
  • blood tests 
  • heart trace
  • CT scan or MRI scan

You then see the doctor about 3 months later to see if you have any side effects.

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.

INCB099318 can affect the immune system. It may cause inflammation or immune reactions in different parts of the body. These reactions are usually well tolerated but 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.

INCB099318 is a new drug and there may be side effects we don’t know about yet. Only a small number of healthy volunteers have taken it and the side effects reported were:

  • headaches
  • skin rash

Your doctor will talk to about the possible side effects before you agree to take part in the study.

Location

Edinburgh
London
Newcastle upon Tyne

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr David Pinato

Supported by

Incyte Corporation

Freephone 0808 800 4040

Last review date

CRUK internal database number:

18046

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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