Race Oncology (ASX:RAC) has received human ethics approval to commence its HARNESS-1 Phase 1a/b clinical trial evaluating RC220, its next-generation formulation of bisantrene, in combination with AstraZeneca's TAGRISSO (osimertinib) for patients with EGFR-mutated non-small cell lung cancer (NSCLC).
The approval, granted by the St Vincent’s Hospital Melbourne Human Research Ethics Committee, marks a significant step for the company as it advances its precision-targeted oncology program.
The lead clinical site at Monash Health in Victoria is preparing to begin enrolling patients once final site activation and institutional processes are completed, expected in late 2025 or early 2026. Four additional sites are planned for activation in the coming months, expanding the multi-centre study’s reach across Australia.
The HARNESS-1 study will assess the safety, tolerability and pharmacokinetics of RC220, a G-quadruplex binder designed to inhibit key resistance pathways, when used alongside standard-of-care osimertinib in patients with activating EGFR mutations.
Recruitment will begin with a circulating tumour DNA (ctDNA) screening stage, followed by a dose-escalation Phase 1a involving 12 to 40 participants who will receive intravenous RC220 on day 1 of a 21-day cycle.
Once the maximum tolerated dose has been established, the company will proceed to the double-blind, randomised Phase 1b component, in which 40 patients will be assigned to one of two dose levels. This stage will evaluate safety and PK while also exploring progression-free survival, overall survival, changes in ctDNA and shifts in cancer-specific mutations.
Race Oncology Principal Scientist Dr Rodney Cusack said the approval marks a key step forward for a therapy specifically designed to address treatment resistance. “The mechanism of action of (E,E)-bisantrene as a G-quadruplex binder promises to address key pathways of resistance identified in EGFR mutated NSCLC,” he said. “This human ethics approval now enables Race to open a clinical trial in patients with EGFR mutated NSCLC and who have progressed or who are at risk of progressing while on treatment, setting the drug up to make a significant impact in this patient population.”
Race Oncology CEO and Managing Director Dr Daniel Tillett welcomed the milestone, noting the urgent need for new therapeutic options for patients who fail third-generation tyrosine kinase inhibitors. “Obtaining human ethics approval for this second study of RC220 is another major achievement for Race,” he said. “In this trial we aim to address the significant unmet medical need for better treatments for patients who develop resistance to third-generation EGFRm NSCLC tyrosine kinase inhibitors. I wish to thank the St Vincents Hospital Melbourne HREC, the St Vincents Research Valet Service, and the entire Race and Beyond Drug Development teams for their efforts and dedication.”