• St Vincents Hospital (Melbourne) Human Research Ethics Committee has approved the HARNESS-1 Phase 1a/b trial of RC220 in combination with osimertinib
• Trial will enroll adult non-small cell lung cancer patients with activating driver mutations in the epidermal growth factor receptor
• Four additional clinical trial sites expected to be activated in the coming months

Race Oncology Ltd is pleased to announce it has received human ethics approval from the St Vincents Hospital Melbourne Human Research Ethics Committee (HREC) to initiate a Phase 1a/b clinical trial assessing the safety, tolerability and pharmacokinetics (PK) of RC220 (E,E- bisantrene, RCDS1) with osimertinib (Tagrisso®; AstraZenica), in patients with non-small cell lung cancer (NSCLC) that have activating epidermal growth factor receptor mutations (EGFRm). This approval allows Monash Health (Clayton, Victoria), under the supervision of the Principal Investigator, Dr Surein Arulananda, to commence enrolling patients for the trial with the support of Beyond Drug Development. Patient enrolment is subject to final institutional approval and site activation by Monash Health, expected late Q4 2025 to early Q1 2026. The trial is a multi-centre, Phase 1a/b study, using circulating tumour DNA (ctDNA) to screen and enrol EGFRm NSCLC patients receiving treatment with osimertnib. Phase 1a 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 osimertinib. Once the maximum tolerated dose (MTD) of RC220 has been determined, the trial will progress to the double-blind, randomised Phase1b stage (dose expansion) where 40 patients will be randomized to one of two treatment dose levels. Patients will be monitored for safety, PK, progression free survival, overall survival, changes in ctDNA, and changes in cancer-specific mutations.

Race Oncology is advancing a proprietary formulation of RCDS1 (RC220) to address the high unmet needs of patients across multiple oncology indications, with Phase 3 clinical programs in acute myeloid leukaemia (AML), Phase 1a/b program in mutant epidermal growth factor receptor non-small cell lung cancer (EGFRm NSCLC), and a Phase 1a/b program in combination with the anthracycline doxorubicin.