Racura Oncology Launches HARNESS-1 Trial for Lung Cancer Treatment

The inaugural participant received a 50 mg/m2 intravenous infusion of RC220 at Monash Health in Clayton, Victoria, under the supervision of Associate Professor Surein Arulananda. No adverse events were reported following the initial administration. The trial aims to determine whether RC220, a proprietary formulation of (E,E)-bisantrene, can safely complement osimertinib—the current standard-of-care third-generation EGFR tyrosine kinase inhibitor—to prevent or delay the development of acquired therapeutic resistance.

While osimertinib has significantly improved outcomes for patients with EGFR-driven lung cancer, resistance remains a primary clinical hurdle. Racura Oncology’s approach involves targeting non-canonical G-quadruplex DNA and RNA structures to disrupt transcriptional networks, specifically those involving the c-MYC growth pathway. The Phase 1a dose-escalation stage will involve between 12 and 40 participants, evaluating safety and pharmacokinetics before the trial potentially moves into a randomized expansion phase. Additional recruitment sites are scheduled to open in the coming months.