• First patient recruited to HARNESS-1 Phase 1 trial of RC220 in EGFR non-small cell lung cancer
• Trial aims to address unmet medical need of preventing or delaying resistance to EGFR-mutant tyrosine kinase inhibitors
• Four additional clinical trial sites expected to be activated in the coming months

Racura Oncology Ltd has announced that the first patient has been recruited to its Phase 1 HARNESS-1 clinical trial. The HARNESS-1 trial will assess the safety, tolerability and pharmacokinetics (PK) of RC220 (E,E-bisantrene) in combination with the standard of care tyrosine kinase inhibitor (TKI) osimertinib (Tagrisso®; AstraZeneca) in patients with non-small cell lung cancer (NSCLC) who have activating epidermal growth factor receptor mutations (EGFRm). The first participant has been consented onto the trial by Principal Investigator Associate Professor Surein Arulananda and his team at Monash Health (Clayton, Victoria). The HARNESS-1 trial is a multi-centre, Phase 1a/b study, using circulating tumour DNA (ctDNA) to screen and enrol EGFRm NSCLC patients receiving treatment with osimertinib. The trial will commence with a ctDNA screening stage, followed by dose escalation of RC220 when patients have evidence of disease progression. Once the maximum tolerated dose (MTD) of RC220 has been determined, the trial will move to a double-blind, randomised dose expansion Phase 1b stage. Racura Oncology CEO and Managing Director, Dr Daniel Tillett, commented that the enrolment of the first patient is a significant milestone for the company, and they are grateful to the clinical team at Monash Health for their work in activating the trial and recruiting the first participant.

The HARNESS-1 trial is expected to provide evidence related to the safety and efficacy of RC220 in combination with osimertinib for the treatment of EGFR-mutant non-small cell lung cancer. Four additional clinical trial sites are expected to be activated on the trial in the coming months.