A trial of samuraciclib for advanced cancer (Modules 1A, 1B and 2A)

Cancer type:

Breast cancer

Secondary cancers

Status:

Results

Phase:

Phase 1

This trial looked at samuraciclib for cancer that had spread to nearby tissue or to another part of the body. This is called advanced cancer.

Some parts of the trial were for people with triple negative breast cancer. This is breast cancer that doesn’t have receptors for:

the hormones oestrogen and progesterone
a protein called HER2

The trial was open for people to join between 2017 and 2022. The team published the results in 2023.

More about this trial

There were 3 main parts to this trial. They were all for people with advanced cancer who had already had treatment:

module 1A was for people with a solid tumour (any cancer apart from leukaemia or lymphoma)
module 1B was for people with triple negative breast cancer (TNBC)
module 2A was for people with breast cancer that had hormone receptors but not HER2 receptors

Doctors often use chemotherapy to treat cancer that has come back or spread to another part of the body. But sometimes it continues to grow.

Researchers want to find out if samuraciclib (CT7001) is a useful treatment for people in this situation.

Samuraciclib is a type of targeted cancer treatment. It stops one of the signals that cancer cells need to divide and grow.

The main aims of this trial were to find out:

the best dose of samuraciclib to give
what the side effects are
how well it works

Summary of results

This trial showed that samuraciclib didn’t cause too many side effects. And that it helped stopped the cancer growing in some people.

Trial design
A total of 98 people joined this trial. They all had cancer that had spread to the surrounding area or another part of the body.

There were 44 people in module 1A. The first few people had the lowest dose of samuraciclib. They didn’t have any serious side effects, so the next few people had a higher dose. This is called dose escalation. There were 5 dose levels in total.

There were 23 people in module 1B. They all had the same dose of samuraciclib. The researchers decided which dose to use based on the results of module 1A.

There were 31 people in module 2A. They had samuraciclib and fulvestrant, a type of hormone therapy. Six people had a lower dose of samuraciclib, and 25 people had a higher dose.

Side effects
Most people (98%) had at least 1 side effect from treatment. They were nearly all mild or didn’t last long. But 6 people had a side effect that was more severe.

The most common side effects were:

feeling or being sick
diarrhoea
tiredness (fatigue)

Samuraciclib didn’t cause any extra side effects in people who had fulvestrant as well. There wasn’t any evidence of an interaction between the two treatments.

How well treatment worked
The trial team looked at how many people’s cancer responded to treatment.

They were able to look at this in 30 people in module 1A. This was the dose escalation part of the trial. The cancer had:

got a bit smaller in 1 person (3%)
stayed the same in 15 people (50%)
continued to grow in 14 people (47%)

They were able to look at this in 20 people in module 1B. People in this part all had the same dose of samuraciclib. The cancer had:

got a bit smaller in 1 person (5%)
stayed the same in 11 people (55%)
continued to grow in 8 people (40%)

And they were able to look at this in 25 people in module 2A. People in this part had samuraciclib and fulvestrant. The cancer had:

got a bit smaller in 3 people (12%)
stayed the same in 13 people (52%)
continued to grow in 9 people (36%)

The team looked in more detail at which groups of patients the treatment worked best for. They looked at a number of different factors, including changes (mutations) in various genes.

They found it worked best for people:

who did not have a change (mutation) in a gene called TP53
whose cancer had not spread to their liver when they joined the trial

Conclusion
The team concluded that samuraciclib:

didn’t cause too many side effects
may be a useful treatment for some people with advanced cancer

But the number of people in this trial was relatively small. So it’s difficult to say for sure. The team suggest more trials are done to find out more.

More detailed information
There is more information about this research in the reference below.

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

Dose escalation and expansion cohorts in patients with advanced breast cancer in a Phase I study of the CDK7-inhibitor samuraciclib
R. C. Coombes and others
Nature Communications, 2023. Volume 14, article number 4444.

Where this information comes from
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.