
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
This trial is looking at the best dose of HTL0039732 for that have spread to another part of the body. It is also looking at the best dose of HTL0039732 to have with atezolizumab or other cancer drugs.
The trial is for people whose cancer is getting worse and there is no standard treatment available.
A solid tumour is any cancer apart from cancers of the blood such as and
.
Cancer Research UK supports this trial.
Cancer that has spread to another part of the body is sometimes called advanced cancer. Doctors are trying to improve treatment for people with advanced cancer.
In this trial they are looking at a new drug called HTL0039732. This is the first time people are having it. HTL0039732 is a type of . It blocks a protein that stops the
from attacking cancer cells. Doctors think this will stop or slow cancer growth.
They also want to see if having HTL0039732 with atezolizumab or other cancer drugs could work to stop or slow cancer growth. Atezolizumab is also an immunotherapy.
In this trial, some people have HTL0039732 on its own and some people have HTL0039732 and atezolizumab. This is part 1 of the trial. At a later stage, the team plan to see how well HTL0039732 works alongside other cancer drugs. This is part 2 of the trial.
To begin with, the researchers need to find the best dose of HTL0039732 to give by itself and in combination with atezolizumab.
The main aims of the trial are to:
The following bullet points are a summary of 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
Part 1 (group A)
You may be able to join this part to have HTL0039732 on its own if all of the following apply. You have:
Part 1 (group B)
You may be able to join this part to have HTL0039732 and atezolizumab if all of the following apply. You have:
These include one of the following:
As well as the above, for both parts, all of the following must also apply. You:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
As well as the above, to join part 1, group B, the following can’t apply. You
This is a phase 1/2 trial. It has 2 parts. The team need 150 people to join.
Part 1 (group A dose escalation)
This part of the trial opens first. It is open to recruitment.
It is looking at the best dose of HTL0039732 to have on its own. The best dose is the highest dose with the fewest side effects. The first few people have a low dose. The next few people have a higher dose if they don’t have any side effects. And so on until they find the best dose to give.
You have that last 3 weeks.
HTL0039732 is a capsule. You take:
You swallow the capsules whole with a glass of water. The team may ask you to not eat or drink anything (except water) for 2 hours before you take your capsules and for 1 hour afterwards. The team let you know how many capsules to take and when to take them. This depends on when you join the trial.
You have HTL0039732 for up to a year as long as it is working and the side effects aren’t too bad.
Part 1 (group B dose escalation)
This part of the trial opens soon after part 1, group A begins.
It is looking at the best dose of HTL0039732 to have with atezolizumab.
You have:
You have HTL0039732 once a day, every day. You have atezolizumab as a drip into a vein, once every 3 weeks.
You have HTL0039732 and atezolizumab for up to a year.
Part 2 (dose expansion)
This part won’t start until part 1 (group A and group B) are complete.
You have HTL0039732 in combination with other cancer drugs. We’ll add more information about this part of the trial when it opens.
Samples for research
In part 1, group B, the researchers ask you to give an extra tissue sample before you start treatment and one extra sample during the trial. You need to say yes to this to join this part.
The team ask everyone to give some extra blood samples. Where possible, you have these at the same time as your routine blood tests. They also ask for some urine samples.
The researchers plan to use the samples to:
You see the doctor and have some tests before you can take part. These include:
You might also need to have a bone scan if you have prostate cancer.
Those having atezolizumab have it at the hospital in the outpatients department.
You see the doctor often while having treatment. This is to see how you are and for blood tests. Some of the hospital visits are long and might take a full day. The team can tell you roughly how long you can expect to be at the hospital. You also have some overnight stays. The trial team can tell you when these take place.
Trial scans
You have a CT scan or MRI scan:
You stop having the trial scans if the cancer gets worse.
Follow up
You see the trial team a month after you stop treatment. The team then follow you up every month to see how you are getting on. They might see you at a routine hospital appointment or give you a call. They may also check your medical notes.
The trial 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.
HTL0039732 and atezolizumab can affect the 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. |
This is the first time people are having HTL0039732 on its own and with atezolizumab. So there may be side effects we don’t know about yet.
The possible side effects of HTL0039732 include:
The most common side effects of atezolizumab include:
We have more information about atezolizumab and its side effects.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Bristi Basu
Cancer Research UK (Centre for Drug Development)
Sosei Heptares
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”