A trial looking at treatment for bowel cancer that has spread (ADEPT)

Cancer type:

Bowel (colorectal) cancer

Colon cancer

Rectal cancer

Status:

Results

Phase:

Phase 1

This trial was looking at a monoclonal antibody treatment for bowel cancer that had spread to another part of the body. This trial was supported by Cancer Research UK.

Bowel cancer (colorectal cancer) is often treated with surgery and chemotherapy. But sometimes the cancer continues to grow, or the cancer comes back after treatment (recurs). When this happens, more chemotherapy can sometimes help to slow the growth of the cancer. But doctors are always looking for new and more effective treatments.

Monoclonal antibodies are a new way of treating some types of cancer. They are a type of biological therapy. The treatment involves using antibodies made in a laboratory to target specific cancer cells.

ADEPT was a type of monoclonal antibody treatment called Antibody Directed Enzyme Pro drug Therapy. The treatment was given in 2 stages. Firstly a monoclonal antibody was given. This antibody had an enzyme attached to it. The idea was that the antibody carried the enzyme to cancer cells around the body. Secondly, an inactive anti cancer drug called a pro drug was given. When the pro drug and the enzymes meet in the cancer cell, the pro drug became active. The doctors hoped that this drug would then kill the cancer cell.

This was a phase1 trial of an experimental treatment. The doctors didn’t know how effective it would be.

The aims of this trial were to find out

If ADEPT could help people with bowel cancer that had spread to another part of the body
What was the best dose to give
What was the most number of treatments that could be given
What were the side effects
What happened to ADEPT in the body

Summary of results

The researchers were able to recruit 43 people into this trial. And were able to make conclusions about

The best dose of ADEPT to give
The number of treatments to give
The side effects of ADEPT
How ADEPT could help people with advanced bowel cancer

The researchers did this trial in 2 parts. The first part recruited 31 people and was a ‘dose escalation study’. This means that the first few people had the lowest dose of ADEPT. The next few people taking part had a higher dose. And so on until the researchers found the best dose to give.

In the second part of the trial, the researchers recruited 12 people. They looked at the number of repeat treatments of ADEPT that could be given, increasing the number by one each time. The maximum number of repeat treatments that could be given was found to be 3. And the most common side effects were

A drop in blood cells
Feeling, or being, sick
Tiredness

Of the 43 people recruited in the trial, 28 had scans to find out if ADEPT had helped their cancer. The scans of 16 people showed that their cancer did not get better or worse. And the scans of the remaining 12 people showed their cancer had kept growing. So the researchers concluded that there was no clear evidence that ADEPT helped.

We have based this summary on information from the team who ran the trial. As far as we are aware, the information they sent us has not been reviewed independently (peer reviewed Open a glossary item ) or published in a medical journal yet. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.