A multi-centre phase-two study will represent the fourth clinical trial ongoing for Kazia’s GDC-0084 drug candidate

Kazia Therapeutics Ltd, an Australian oncology-focused biotechnology company, has recently entered into a partnership with the Alliance for Clinical Trials in Oncology Foundation, the US-based cancer research network, for introducing a multi-centre phase-two study exploring the potential use of GDC-0084 drug from Kazia in treating brain metastases.

Apparently, a multi-centre phase-two study will represent the fourth clinical trial ongoing for Kazia’s GDC-0084 drug candidate, with every trial treating different types of brain cancer. Alliance for Clinical Trials in Oncology Foundation is sponsored by the National Cancer Institute and it will examine various other targeted cancer therapies.

James Garner, Chief Executive Officer of Kazia, stated that patients will be assigned to treatment based on their individual genetic signature of tumour and apart from this, patients with a mutation that affects the PI3K pathway will be entitled to get GDC-0084.

Seemingly, Alliance would be initiating the open-label phase-two study which will aid in allocating to patients either entrectinib (Genentech), abemaciclib (Eli Lilly) or Kazia’s GDC-0084 drug, based on their tumour’s genetic profile.

Sources familiar with the matter mentioned that the trial is projected to recruit nearly 150 patients across various US medical centres and Kazia will provide support, including a financial grant and the study drug. With regards to the PI3K pathway, only patients with a genetic alteration will get GDC-0084 drug, which is anticipated to include around one-third of total patients employed.

On the other hand, patients with other kind of genetic mutations will get either Trk/ALK inhibitor entrectinib which is still in process of approval by the Federal Drug Administration (FDA), or CDK inhibitor abemaciclib, approved by the FDA for the treatment of certain types of breast cancer.

The study is reportedly expected to take around two years to complete and will be organized under an investigator IND along with the US FDA, where Alliance will undertake key regulatory responsibilities for the study.

Source credit: https://www.proactiveinvestors.com.au/companies/news/220551/kazia-therapeutics-to-collaborate-with-us-based-oncology-foundation-on-clinical-trials-for-metastatic-brain-cancer-treatment-220551.html