Australian biotech firm Racura Oncology (ASX:RAC) secured critical governance approval from Monash Health, marking a milestone for its Phase 1 clinical trial, HARNESS-1.
The study focuses on RC220 (E,E-bisantrene) in combination with the standard-of-care therapy, osimertinib (Tagrisso), targeting patients with epidermal growth factor receptor-mutant (EGFRm) non-small cell lung cancer.
The approval follows the human ethics clearance received in late 2025, confirming that the necessary infrastructure and oversight are now in place at the Monash Medical Centre in Victoria.
The HARNESS-1 trial addresses a major clinical hurdle: the development of resistance to current tyrosine kinase inhibitors.
RC220 functions as an RNA and DNA G4 binder, designed to disrupt the pathways that allow tumours to bypass treatment.
Principal Scientist Dr. Rodney Cusack emphasised that this milestone brings the company closer to providing a meaningful solution for patients facing limited options.
The trial employs an innovative Phase 1a/b design, utilising circulating tumour DNA for patient screening.
Initial stages will use an accelerated trial design with single-patient cohorts to evaluate safety before transitioning into a Bayesian Optimal Interval study to determine the maximum tolerated dose.
Between 12 and 40 participants are expected to be enrolled, receiving intravenous infusions of RC220 every 21 days.
With site training scheduled for March 23 under Principal Investigator Dr. Surein Arulananda, patient recruitment is imminent, with four additional clinical sites expected to activate in the coming months.