Kazia Therapeutics Ltd (ASX:KZA) (NASDAQ:KZIA) will investigate the potential use of its drug GDC-0084 in combination with radiotherapy in a phase I clinical trial for cancer that has spread to the brain, at the Memorial Sloan Kettering Cancer Center (MSK) in New York.
This research will explore a new use of GDC-0084 and will run concurrently with other ongoing studies in different forms of brain cancer.
Initiation of this study brings to five the total number of ongoing clinical trials with GDC0084, each in different forms of brain cancer.
Kazia chief executive officer Dr James Garner said: “MSK is one of the world’s leading cancer treatment centres, and we are privileged to be supporting them in this state-of-the-art project.
“Many cancers have the potential to spread to the brain, and they become very difficult to treat when they do.
“The work being done at MSK will investigate whether GDC-0084 has the potential to enhance the effects of radiotherapy, which remains the current standard of care in most cases.”
MSK will initiate a phase I clinical trial of GDC-0084 in combination with radiotherapy for patients with solid tumour brain metastases (cancer that has spread to the brain) and leptomeningeal metastases that harbours a genetic alteration in the PI3K pathway.
The trial will be led by MSK, with Kazia providing support including study drug and a financial grant and is expected to take about two years to complete.
Up to 30% of patients with metastatic cancer will develop secondary tumours (metastases) in the brain.
Radiotherapy remains the standard of care, but 30-50% of patients will progress within one year, despite the best available treatment.
In animal models of certain cancers, activation of the PI3K pathway has been shown to contribute to radiotherapy resistance.
GDC0084 is a PI3K inhibitor that can cross the blood-brain barrier, and as such it may be able to reduce the problem of resistance to radiotherapy. This clinical trial has been developed to test that hypothesis.
The trial is expected to recruit 18-30 patients, all of whom will have cancer that has spread to the brain.
Patients will be genetically tested for a specific alteration in the PI3K pathway, and only those with a relevant mutation will be enrolled.
This is an example of an approach to clinical research that is sometimes referred to as ‘precision medicine’ or ‘personalised medicine’, in which treatments are carefully targeted to those patients most likely to benefit.
It is expected that the trial will begin recruitment in the second half of calendar 2019.