• Bellberry Human Research Ethics Committee approves Race's Phase 1 trial of RC220 in combination with doxorubicin
• Trial to assess safety, tolerability and pharmacokinetics of RC220 alone and in combination
• Expansion stage to confirm safety and explore cardioprotection, anticancer, anti-aging effects

Race Oncology Ltd has received approval from the Bellberry Human Research Ethics Committee (HREC) to initiate a Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetics (PK) of RC220 bisantrene alone and in combination with doxorubicin, in patients with solid tumours. This approval allows the lead clinical site, Southside Cancer Care Centre, to commence enrolling patients for the trial, subject to institutional approval and site activation in March 2025, with up to nine other sites to follow. The trial is an open-label, multi-centre, Phase 1 study and will be conducted in two stages. Stage 1 will commence with a dose escalation of RC220, where up to 33 patients will be enrolled and receive intravenous (IV) infusion of RC220 alone on Day 1 before progressing to a combination treatment, where patients will receive IV RC220 followed by IV doxorubicin on a 21-day cycle. Once the maximum tolerated combined dose (MTCD) has been determined, Stage 2 will recruit patients with solid tumours who have not previously been treated with doxorubicin or other anthracyclines. Patients will receive the optimal dosage of RC220 in combination with doxorubicin to confirm the safety of the combination and study a range of exploratory endpoints, including cardioprotection, anticancer, anti-aging and other clinical biomarkers, such as the effects of RC220 on the m6A RNA regulatory system.

Race expects that most Australian sites will be activated by George Clinical in Q1 or Q2 CY2025. As Hong Kong and South Korean sites have a longer regulatory review process, activation is expected in Q3 2025.