A pioneering research study which will allow brain cancer patients to access drugs that are precisely targeted to their disease and swap to different treatments if needed, has launched in the UK. The 5G (next-Generation aGile Genomically Guided Glioma platform) study is the world’s first adaptive clinical trial platform for patients with brain tumours.
It is hoped that the investigator-initiated trial, which is sponsored by The Institute of Cancer Research, London, and conducted by the Joint Drug Development Unit at The Institute of Cancer Research (ICR) and The Royal Marsden NHS Foundation Trust, will speed up the development of new treatments for glioblastoma, an aggressive form of brain cancer.
As part of the trial, every patient will also have their genome sequenced, enabling researchers to target their treatment with greater precision. The drug or drug combination each patient receives will be based on the specific genetic makeup of their tumours.
Multiple drugs to be tested
The 5G trial platform, which is funded by Cancer Research UK and Australian charity, the Minderoo Foundation, will allow multiple drugs to be trialled at the same time and, for the first time, allows treatments developed for other types of cancer to be trialled in patients with brain cancer.
Drugs given to patients can be changed as real-time data is collected and incorporated, making it easier for researchers to try multiple treatment options across different groups of patients. This both benefits the trial itself and improves the likelihood of a positive outcome for participants.
Dr Juanita Lopez from the ICR and Dr Richard Mair at the Cancer Research UK Cambridge Institute will co-lead the trial.
‘A unique opportunity to find better treatments for patients’
Dr Juanita Lopez, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust and Group Leader in Early Phase Drug Development at The Institute of Cancer Research, London, said:
“We have seen progress made in better treating many types of cancer in recent decades, but less so in brain cancers like glioblastoma.
“The 5G platform trial presents a unique opportunity to work in new and exciting ways to find better treatment options for this patient population.”
Dr Richard Mair, Honorary Consultant Neurosurgeon at Cambridge University Hospitals NHS Foundation Trust and co-lead of the Brain Cancer Virtual Institute at the Cancer Research UK Cambridge Centre, said:
“Brain cancers like glioblastoma are notoriously difficult to treat. I am excited to co-lead this world-first trial designed with this cancer type in mind.
“The use of whole genome sequencing for every patient on the trial performed in ‘real time’ enables us to be both agile and precise in our drug targeting. We hope that this approach will help patients with this cancer of unmet need.”
No significant breakthroughs in decades
Glioblastomas are the most common type of cancerous brain tumour in adults, making up nearly a third (32 per cent) of primary brain tumours diagnosed in England between 1995 and 2017.
Due to the unique biology of the brain, however, finding new treatments has proven difficult. There have been over 1,000 brain cancer clinical trials over the past two decades, but these have not yielded significant breakthroughs.
To help address this, Cancer Research UK and Minderoo Foundation are each committing £1.68m (£3.36m total) to fund the 5G platform.
Chief Executive of Cancer Research UK, Michelle Mitchell said:
“Brain tumours are notoriously hard to treat because we still don’t know enough about the biology of the disease, and current treatments are not effective enough.
“This new trial offers something different because researchers will use the DNA of participants to help them target treatments. Whole genome sequencing tests can give clues about how a cancer may have developed, how it will behave and what treatment options would work best.
“More research is needed, but it is hoped that the technology could one day be used within the NHS to improve the treatment and care of people with cancer.”
The co-founder of Minderoo Foundation, Dr Andrew Forrest AO, said:
“Minderoo Foundation was established to take on tough and persistent challenges. There are few greater challenges than brain cancer.
“Our investment in this ground-breaking study reinforces Minderoo’s commitment to being part of a world where cancer treatment options are not constrained and hope is available for all – no matter how common or rare your cancer is.”
First sites already open
The first 5G study sites opened in August 2024, with further sites planned across the UK as the study progresses. The drugs used in the study will be provided by pharmaceutical industry partners.
The trial involves researchers at the Cancer Research UK-funded ICR Clinical Trials and Statistics Unit (ICR-CTSU) and is supported by the National Institute of Health Research Biomedical Research Centre (NIHR BRC) at the Royal Marsden and the ICR
It is taking place in partnership with the Minderoo Precision Brain Tumour Programme, which is sponsored by Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge.
The funding of this study forms part of Cancer Research UK’s long-term commitment to investing in brain cancer research. Cancer Research UK recently announced £8m additional funding for two Brain Tumour Centres of Excellence.