Kazia Therapeutics Ltd (ASX:KZA) has entered into a collaboration with the Alliance for Clinical Trials in Oncology Foundation (Alliance) to launch a multi-centre phase-two study investigating the potential use of Kazia’s GDC-0084 drug in treating brain metastases.
The US-based cancer research network is sponsored by the National Cancer Institute and will also investigate several other targeted cancer therapies.
Kazia chief executive officer James Garner said the Alliance study was a ground-breaking research project that aims to investigate several experimental drugs in a single clinical study.
He said: “Patients will be allocated to treatment depending on their tumour’s individual genetic signature and patients with a mutation affecting the PI3K pathway will be eligible to receive GDC-0084.
“This kind of approach is very much the future of cancer treatment.”
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Alliance is to initiate the open-label phase-two study which will allocate to patients either abemaciclib (Eli Lilly), entrectinib (Genentech) or Kazia’s GDC-0084, based on the genetic profile of their tumour.
The trial is expected to recruit up to 150 patients across multiple US medical centres and Kazia will support it by providing the study drug and a financial grant.
Only patients with a genetic alteration in the PI3K pathway will receive GDC-0084, which is expected to comprise about one-third of total patients recruited.
Patients with other genetic mutations will receive either CDK inhibitor abemaciclib, approved by the Federal Drug Administration (FDA) for treatment of certain forms of breast cancer, or Trk/ALK inhibitor entrectinib which has not yet been approved by the FDA.
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Harvard Medical School Assistant Professor of Medicine and principal investigator of the study Priscilla Brastianos said brain metastases represented an unmet clinical need.
She said: “We urgently need to find better treatment options for these patients.
“We hope this study will help us identify a new treatment paradigm.”
The study is expected to take about two years to complete and will be conducted under an “investigator IND” with the US FDA, where Alliance will assume primary regulatory responsibilities for the study.
Implementation of the study is conditional on approval from applicable institutional review boards and completion of contractual formalities, which have not yet been finalised.
Kazia anticipates patient recruitment will begin in the second half of this year.