Race Oncology Ltd (ASX:RAC) has received human ethics approval for its open-label clinical trial of Zantrene® in patients with extramedullary Acute Myeloid Leukaemia (AML) and high-risk Myelodysplastic Syndrome (MDS).
Notably, this will be the first clinical trial in the world to investigate the targeting of fat mass and obesity associated (FTO) gene as a potential cancer therapy using an AML & MDS population.
Race is now awaiting Research Governance Office approval for the trial, which is expected in the coming weeks in advance of the first patient being enrolled in the study.
“Expand study”
Race CMO Dr David Fuller said “We are pleased to receive this first human ethics approval and expect to expand the study to more approved Australian sites in the coming months.
“In addition, based on positive feedback from European clinical key opinion leaders and supported by the proceeds of our recent share purchase plan, we look forward to adding additional trial sites in Europe.”
Clinical trial design
This open-label phase 1 trial with a Phase 2 dose-expansion phase will recruit up to 60 patients with 18F-FDG PET/CT imaging-identified extramedullary AML at 10 clinical sites using a two-stratum (arm) design.
The first stratum will utilise Zantrene as a high dose, single-agent treatment over seven days in patients with extramedullary AML who can tolerate high-intensity chemotherapy, followed by one or more cycles of consolidation treatment of Zantrene in combination with Ara-C, a standard of care drug.
The second stratum will use Zantrene as a low dose FTO-targeted agent in combination with the oral hypomethylating agent, ASTX727 for MDS or AML patients unwilling, or unable to tolerate high-intensity chemotherapy.
Timeline
The clinical trial is expected to take 36 to 40 months to complete with full patient recruitment over 18 months.
Being open-label in nature, patient outcome results are obtained as patients are treated.
The first patient is expected to begin treatment soon after governance approval is obtained.