A trial of BT1718 for advanced cancer
Cancer type:
Status:
Phase:
This trial looked at a drug called BT1718 for people with 
, including cancers that had spread elsewhere in the body.
The trial was supported by Cancer Research UK. It was open for people to join between 2018 and 2023. The research team reported the results in 2024.
More about this trial
Researchers are looking for new ways to treat people with advanced solid tumours when there are no available. A means any cancer that is not a blood cancer.
BT1718 is a type of targeted treatment called a Bicycle drug conjugate or Bicycle toxin conjugate. It is a combination of a and a chemotherapy drug called DM1.
BT1718 recognises and attaches to a protein called MT1-MMP. Some cancer cells have higher levels of MT1-MMP than healthy cells. BT1718 binds to the MT1-MMP protein, and this delivers the DM1 chemotherapy directly to the cancer cell. The aim is for the DM1 chemotherapy to then kill the cancer cell.
There were 2 parts in this trial.
Phase 1 was done to find the best dose of BT1718 to use. It was for people with any type of solid tumour.
The first few people who joined this part of the trial had a low dose of BT1718. And the next few had a higher dose. This is called dose escalation.
There were 2 parts in the dose escalation. The people in one part had BT1718 twice a week. The people in the next part had BT1718 once a week. This was to find out how often to give BT1718.
Phase 2 was for people with high levels of the MT1-MMP protein on their cancer cells. There were 2 groups in phase 2. One group was for people with (NSCLC). The other group was for people with any type of cancer other than NSCLC.
The research team used the results from phase 1 to decide which dose to use in phase 2 and how often to give it. This is called dose expansion.
The main aims of this trial were to find out:
- the best dose of BT1718 to use
- more about the side effects
- what happens to the drug in the body
- how well treatment works
Summary of results
A total of 69 people joined this trial. They were between 22 and 78 years old. There were:
- 39 people in phase 1 (dose escalation)
- 30 people in phase 2 (dose expansion)
They all had and there were no available for them. People with serious heart conditions or other serious medical conditions were not able to take part.
People had BT1718 as a drip through a tube (cannula) into a vein. They had either 1 or 2 doses a week, depending on which group they were in. They had treatment for 3 weeks, and then no treatment for a week. Each 4 week period is one .
Side effects
The trial team were able to look at the side effects for 66 people who took part. Three people who joined the trial didn’t have any treatment.
Just over 9 out of 10 people (91%) had at least one side effect caused by BT1718. Some side effects were mild, but others were more serious.
Researchers can class a side effect as serious for a number of reasons, including if:
- the person has to go to hospital because of it
- it is particularly important for the trial or the treatment being looked at
Some people needed to delay or stop BT1718 treatment because of side effects they were having. This was:
- just over 2 out of 10 people (21%) in phase 1
- just under 2 out of 10 people (19%) in phase 2
No one taking part died because of side effects caused by BT1718.
Serious side effects in phase 1
Just over 1 in 10 people (13%) in phase 1 had at least one serious side effect. Some people had more than one.
In total:
- 2 people had extreme tiredness (fatigue)
- 2 people had an increase in liver proteins or
enzymes which can be a sign of liver problems - 1 person had an infection from the tube (cannula) going into their vein (PICC line) used to give treatment
- 1 person was sick (vomiting)
- 1 person had muscle pain
- 1 person had a sore throat (oropharyngeal pain)
Non serious side effects in phase 1
The most common non serious side effects were:
- 23 people (59%) felt sick (nausea)
- 18 people (46%) were sick (vomiting)
- 17 people (44%) had diarrhoea
- 17 people (44%) had decreased appetite
- 17 people (44%) had numbness or tingling in their hands or feet (peripheral neuropathy)
- 17 people (44%) had extreme tiredness (fatigue)
- 10 people (26%) had low iron levels in their blood (anaemia)
- 10 people (26%) had an increase in a liver protein (
enzyme ) called alanine aminotransferase, which can be a sign of liver problems
Serious side effects in phase 2
Just under 2 in 10 people (19%) in phase 2 had at least one serious side effect. Some people had more than one.
In total:
- 3 people were sick (vomiting)
- 2 people had diarrhoea
- 2 people felt sick (nausea)
- 1 person had tummy pain (abdominal pain)
- 1 person had dehydration
- 1 person had decreased appetite
- 1 person had extreme tiredness (fatigue)
- 1 person had a fast heart rate (tachycardia)
- 1 person had a build up of fluid in their lungs (pulmonary oedema)
Non serious side effects in phase 2
The most common non serious side effects were:
- 13 people (48%) felt sick (nausea)
- 13 people (48%) had extreme tiredness (fatigue)
- 10 people (37%) had numbness or tingling in their hands or feet (peripheral neuropathy)
- 10 people (37%) had diarrhoea
How well treatment worked
The trial team were able to look at this for 48 people who took part.
They compared the scans people had before, during and after treatment. They found that 2 people’s cancer was considerably smaller on one of the scans during treatment. By the next scan the cancer:
- was nearly the same size and had grown only a small amount for one person
- had started to grow again for one person
Overall, the results showed that the cancer:
- stayed the same for 28 people
- continued to grow for 20 people
What happened to BT1718 in the body
The research team wanted to find out what happened to BT1718 in the body after people had treatment. They took blood samples at various times after treatment to measure this.
They looked at the whole drug, and at the DM1 part of the drug on its own.
They found that people who had higher doses of BT1718 had more of the drug in their body. They also found that the whole drug was broken down quickly. But DM1 stayed in the body for longer.
Conclusion
The research team found the most suitable dose of BT1718 that caused the fewest side effects. They also learnt how people responded to BT1718 and the most common side effects.
All clinical trial results add to our knowledge of cancer and how to treat it. And help to shape future research.
Other trials of BT1718 in the future may show different results.
Future plans
When this summary was written there were no other trials being done looking at BT1718. But there may be other trials in the future.
Where this information comes from
We have based this summary on information from the research team. As far as we are aware, the information they sent us has not been reviewed independently () or published in a medical journal yet. The figures we quote above were provided by the research team. We have not analysed the data ourselves.
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 Udai Banerji
Supported by
Cancer Research UK - regulatory@cancer.org.uk ()
The research team would like to thank all the patients who took part in this trial. By doing this, you’ve helped the research team learn more about cancer and how to treat it.
Other information
This is Cancer Research UK trial number CRUKD/17/009.
There is more information about this trial on the ISRCTN website (ISRCTN11160449):
A Phase I/IIa trial of BT1718 in patients with advanced solid tumours.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
