Racura Oncology has treated the first patient in its phase 1 HARNESS‑1 clinical trial of RC220 for EGFR‑mutant non‑small cell lung cancer (NSCLC). The patient received RC220 at 50mg/m² with no adverse events observed during or after infusion, marking the start of dosing in the study.
The patient was treated by Principal Investigator Associate Professor Surein Arulananda and his team at Monash Health in Victoria. HARNESS‑1 is assessing whether RC220 (E,E‑bisantrene) can be safely combined with the standard‑of‑care tyrosine kinase inhibitor osimertinib (Tagrisso; AstraZeneca) in patients with EGFR‑mutant NSCLC, where resistance to targeted therapy remains a major clinical challenge.
The study uses single‑patient cohorts for the first three dose escalations – 50mg/m², 100mg/m² and 150mg/m² – before progressing to larger groups to identify the maximum tolerated dose of RC220 in combination with osimertinib. The staged approach is designed to support careful dose escalation while generating early safety and pharmacokinetic data.
Daniel Tillett, Chief Executive Officer and Managing Director of Racura Oncology, said: “Treating the first patient in HARNESS‑1 is an important step in the clinical development of RC220 and reflects the progress being made across Racura’s oncology pipeline.
“This trial is focused on a patient group where resistance to current targeted therapies remains a significant challenge. We are grateful to A/Prof Surein Arulananda and his team at Monash Health for their work in recruiting and treating the study’s first participant, and we thank the patients and families supporting this clinical research.”
HARNESS‑1 is a multi‑centre phase 1a/b study using circulating tumour DNA to help identify eligible patients.
Between 12 and 40 participants are expected in the dose‑escalation stage, followed by a randomised phase 1b expansion stage enrolling 40 patients to evaluate safety, pharmacokinetics and clinical activity measures including progression‑free and overall survival.
