A trial of BT1718 for advanced cancer

Cancer type:

All cancer types
Secondary cancers

Status:

Open

Phase:

Phase 1/2

This trial is looking at a new drug called BT1718 for people with advanced cancer that has spread elsewhere in the body. 

Cancer Research UK supports this trial. 

More about this trial

Researchers are looking for new ways to treat people with advanced solid tumours Open a glossary item when standard treatments have stopped working. In this trial, they are looking at BT1718.
 
MT1 MMP is a protein. It breaks down other proteins that surround a cell. Cancer cells have higher levels of MT1 MMP than normal cells. This can cause cancer to grow and spread. So, researchers are looking at ways to stop this happening. They think having BT1718 might help.
 
BT1718 is a type of targeted treatment called a small molecule drug. It recognises and attaches itself to the MT1 MMP protein. This causes the cancer cell to die. As cancer cells have more MT1 MMP on their surface than normal cells, healthy cells are less affected. 
 
This trial is in 2 phases. Phase 1 is looking at the best dose of BT1718. Phase 2 will test this dose in a larger number of people. This is the first time people have had BT1718.
 
The main aims of the trial are to find out:
  • the best dose of BT1718
  • what happens to the drug in the body
  • how well treatment works
  • more about the side effects

Who can enter

The following bullet points list 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 phase 1 of this trial if all of the following apply. 
You:
  • have an advanced solid tumour Open a glossary item
  • have had standard treatments but they stopped working and there isn’t a suitable treatment or you don’t want to have more standard treatments
 
As well as the above, you can join phase 2 if the following apply. 
You:
  • have cancer that your doctor can measure on a scan and at least 1 area has got worse since your last scan
  • are willing for the trial team to look at any leftover samples from previous tissue samples (biopsies Open a glossary item
  • have high levels of the protein MT1 MMP in your cancer cells
  • are willing give a new tissue sample of the cancer before and after you have treatment with BT1718
  • have satisfactory blood test results
  • are well enough to carry out all your normal activities, apart from heavy physical work (performance status 0 to 1)
  • are willing to use 2 forms of reliable contraception during the trial and for 6 months afterwards if there is any chance you or your partner could become pregnant
  • are at least 16 years old
 
Who can’t take part
 
You cannot join this trial if any of these apply. 
Cancer related
You:
  • have had radiotherapy unless it was for symptoms (palliative radiotherapy Open a glossary item), hormone treatment, chemotherapy or treatment as part of a clinical trial in the last 4 weeks (or in the last 6 weeks if you had nitrosoureas or mitomycin C)
  • have had a bone marrow transplant Open a glossary item, high doses of chemotherapy or radiotherapy to more than one quarter of your bone marrow within 8 weeks of the first dose of BT1718
  • have cancer spread to your brain unless you have had treatment, don’t have any symptoms and you haven’t had steroids in the last 4 weeks
  • have side effects from past treatments unless they are mild, apart from hair loss or any side effects that your doctor thinks won’t interfere with having treatment
  • have or have had any other cancer which could affect you taking part in this trial, apart from basal cell skin cancer Open a glossary item, squamous cell skin cancer Open a glossary item, early bladder cancer or carcinoma insitu Open a glossary item
 
Medical conditions
You
  • have had surgery and you haven’t fully recovered
  • have any other medical condition including an active uncontrolled infection
  • have HIV
  • have hepatitis B or hepatitis C
  • have a serious heart problem such as an abnormal heart rhythm, congestive heart failure or a lack of oxygen and blood flow to the heart (cardiac ischaemia)
  • are going to take part in another trial using an experimental drug
  • have any other serious medical condition that means you aren’t suitable to take part in this trial
 
Other 
You are sensitive to anything that BT1718 contains.
 
 

Trial design

This is a phase 1/2 trial
 
Phase 1 is open and the researchers hope to find 50 to 60 people to join. Phase 2 will open when they have found the best dose of BT1718 in phase 1. The researchers need 60 to 70 people to join phase 2.
 
Phase 1
In phase 1, the first few people taking part will have a low dose of BT1718. The next few people will have a higher dose if they don’t have any serious side effects. And so on, until they find the best dose. We call this a dose escalation trial.
 
This phase has two stages, Stage 1 and Stage 2. 
 
Phase 2
Once they have found the best dose in part 1, part 2 can begin. This will test the same dose in a larger number of people. This part is for people who have non small cell lung cancer or triple negative breast cancer
 
This phase has two parts, Part A and Part B. 
 
For both phases
You have BT1718 as a drip into a vein or you might have it through a small syringe connected to a pump. It takes about 60 minutes each time. You have treatment in cycles. Each 4 week period is a cycle of treatment.
 
In each cycle:
  • some people have BT1718 twice a week for the first 3 weeks
  • some people have BT1718 once a week for the first 3 weeks
  • everyone has a week without treatment
The trial team will tell more about how often you have treatment. This depends on the phase you join and the group within each phase.
 
You see the doctor at each hospital visit for a quick check up before treatment. At each visit you have some blood tests and a heart trace.
 
You might have treatment for up to 2 years if it is working and the side effects aren’t too bad. 
 
Research samples 
You give some extra blood samples during treatment. The researchers will ask if they can take some extra tissue samples before and after treatment. The researchers will look at the samples to:
  • measure the levels of BT1718 in your blood
  • predict who will benefit from treatment
  • find biomarkers Open a glossary item

Hospital visits

You see a doctor and have some tests before you can join the trial. These include:
  • a physical examination
  • heart trace (ECG Open a glossary item)
  • a test to see how well your kidneys work
  • blood tests
  • CT scan or MRI scan
You have your treatment at the hospital. You might stay overnight so the trial team can keep an eye on you and check any side effects. The trial team will tell you more about how often you stay overnight.
 
You have a CT scan or MRI scan every 8 weeks. You stop treatment if your cancer has continued to grow. Your doctor will discuss other treatment options with you. 
 
When you finish treatment, you have a check up 1 month later. The trial team continue to follow you up every 3 months at routine clinic appointments or they might phone you or check your medical records to see how you are getting on. 
 

Side effects

BT1718 is a new drug, so there might be side effects we don’t know about yet. The trial team will give you a phone number to call them if you are worried about anything.
 
The possible side effects could include:
  • drop in the number of blood cells causing an increased risk of infection, breathlessness, bruising and bleeding
  • a skin reaction where the nurse injects the drug into a vein causing pain and swelling
  • liver changes
  • kidney changes
  • nerve changes such as pins and needles in the hands or feet or weakness in the arms or legs
  • feeling or being sick
  • low or high blood pressure causing dizziness or headaches
  • dry mouth 
 
There is a chance that exposure to sunlight could cause skin side effects while you are having treatment. You should avoid going out in the sun too much. And you should cover up and use sun cream with a high sun protections factor (SPF 30).
 
The trial doctors will explain all the possible side effects before you join the trial.
 
 

Location

Glasgow
London
Manchester

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 Udai Banerji

Supported by

Cancer Research UK 

Other information

This is Cancer Research UK trial number CRUKD/17/009.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15425

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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