• Governance approval received for HARNESS-1 Phase 1 trial of RC220 in EGFR non-small cell lung cancer patients
• Trial aims to prevent or delay resistance to standard of care EGFR-tyrosine kinase inhibitors
• Four additional clinical trial sites expected to be activated in the coming months

Racura Oncology Limited ('Racura') has received governance approval from Monash Health for its Phase 1 clinical trial assessing the safety, tolerability and pharmacokinetics (PK) of RC220 (E,E-bisantrene) in combination with osimertinib (Tagrisso®; AstraZeneca), in patients with non-small cell lung cancer (NSCLC) who have activating epidermal growth factor receptor mutations (EGFRm). 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, where between 12 and 40 patients will receive intravenous (IV) infusion of RC220 on Day 1 of a 21-day cycle in combination with standard of care maintenance osimertinib therapy. Once the maximum tolerated dose (MTD) of RC220 has been determined, the study will progress to a double-blind, randomised dose expansion Phase 1b stage, where 40 participants will be randomised to one of two RC220 dose levels in combination with standard of care osimertinib. Patients will be monitored for safety and PK, together with a range of secondary and exploratory endpoints, including progression free survival (PFS), overall survival (OS), changes in levels of ctDNA, and changes in the cancer-specific mutations present in patients.

With governance approval now secured, Racura Oncology is able to move forward with the clinical trial of RC220 in patients with EGFR-mutated NSCLC. The company remains focused on evaluating the potential of RC220 as an RNA and DNA G4 binder to target key pathways of osimertinib resistance, with the goal of making a meaningful impact for patients.