A trial of ABT-414 for children with a glioblastoma (INTELLANCE 2 sub study)

Cancer type:

Brain (and spinal cord) tumours

Children's cancers

Status:

Results

Phase:

Phase 2

This sub study was for children and young people with a type of brain tumour called a high grade glioma.

It was open to children and young people whose glioma had a larger number of receptors for the protein called epidermal growth factor (EGF Open a glossary item ).

This sub study was open for children and young people to join between 2017 and 2019. The team reported the reported the results on the pharmacy company’s website in 2020.

More about this trial

INTELLANCE 2 was a trial of Depatux-M. This is also known as depatuxizumab mafodotin or ABT-414. It was for adults with glioblastoma. This study was a sub study of INTELLANCE 2 looking at Depatux-M for children and young people with glioma.

Depatux-M is a type of drug called an antibody drug conjugate (ADC). There are 2 parts to an ADC. The first part targets cancer cells by attaching to a particular receptor on the surface of the cancer cell. The second part is a toxin that goes into the cancer cell and kills it.

Depatux-M attaches to the epidermal growth factor receptors (EGFR) on cancer cells.

The aims of the sub study were to find:

how safe it is to use Depatux-M for children and young people with high grade glioma
what happens to Depatux-M in the body
how well Depatux-M works for children and young people with high grade glioma

Summary of results

Researchers stopped the sub study early. This was because another trial showed that Depatux-M didn’t work for people with a glioma. This means that the team weren’t able to answer all their questions.

What the team were able to find out was:

what happened to Depatux-M in the body
the side effects

About this study
The sub study included 6 children and young adults. They were aged from 5 years old to 17 years old.

Everyone had Depatux-M for a year. They also had temozolomide if it was the standard treatment in their country.

Results
To find out what happened to Depatux-M in the body the team took regular blood samples. They found that the amount of Depatux-M in the blood of children and young adults was the same as it was for adults.

Side effects
The side effects reported were:

eye problems including inflammation, dry eyes, pain, blurred vision and being sensitive to bright light
feeling or being sick
tiredness
loss of weight

Conclusion
The study closed early because another study showed that Depatux-M didn’t help people with glioblastoma.

Even though the sub study closed early the information gained adds to our knowledge of glioblastoma and how to treat it.

Where this information comes from
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) but may not have been published in a medical journal. The figures we quote above were provided by the research team. We have not analysed the data ourselves.