Race Oncology doses first patient in trial of RC220 + doxorubicin for solid tumours
Last updated: 11:49 19 Jun 2025 AEST, First published: 21:49 18 Jun 2025 AEST
Race Oncology Ltd (ASX:RAC, OTC:RAONF) has successfully dosed the first patient with the combination of its lead drug RC220 and doxorubicin in its Phase 1 clinical trial targeting advanced solid tumours. The treatment, administered at the Southside Cancer Care Centre in Miranda, NSW, marks a significant milestone in the company's clinical development program.
The dosing was carried out without any treatment-related dose-limiting side effects, an encouraging outcome as Race continues to assess the safety, tolerability, and potential efficacy of this combination.
The trial is designed to evaluate RC220's ability to reduce the cardiotoxicity commonly associated with doxorubicin, a widely used chemotherapy drug that has shown efficacy against a variety of solid tumours but is often limited by its damaging effects on the heart.
Encouraging early safety data
Dr Simon Fisher, vice president of medical at Race Oncology, said the initiation of the trial and early safety observations were encouraging.
“We are partnering well with our Australian sites and working diligently to activate additional sites in Hong Kong and South Korea,” he said. “We remain excited with the progress of RC220 in the clinic and its potential to offer an improved treatment option for the many patients at risk of cardiotoxicity related to doxorubicin therapy.”
This trial follows Race's earlier success in dosing the first patient with RC220 alone in May. It is part of a broader Phase 1 trial designed to assess RC220 in combination with doxorubicin in patients with advanced solid tumours.
The trial, which is being conducted across multiple sites in Australia, Hong Kong, and South Korea, aims to identify the maximum tolerated dose (MTD) of the combination and evaluate its pharmacokinetics and anticancer activity.
Phase 1 trial structure and design
In the first stage of the trial, the safety and tolerability of ascending doses of RC220 will be studied in up to 33 patients.
Once the MTD is determined, a second stage of the trial will begin, enrolling an additional 20 patients to further investigate the combination's safety and early signs of efficacy. Researchers will also examine biomarkers related to cancer progression, including m6A RNA.
The trial's open-label design and use of a Bayesian approach will provide greater flexibility and speed compared with traditional clinical trial methods, allowing Race to efficiently adjust the trial protocol based on interim data. Race has indicated that it will provide updates on trial progress as significant milestones are achieved.
Strong preclinical data supports combination therapy
The combination trial builds on earlier preclinical research, which demonstrated that bisantrene, the active agent in RC220, enhanced the cancer-killing activity of doxorubicin in 85% of the 143 cancer cell lines tested.
In addition, Race's previous research has shown that doxorubicin alone has overall response rates of up to 35% in cancers such as breast, ovarian and lung cancer, among others.
Global expansion and strategic collaborations
As part of its broader strategy, Race Oncology continues to explore strategic collaborations and licensing agreements to expedite the global availability of RC220, with the goal of addressing critical unmet needs in cancer care. The company's research efforts are supported by collaborations with leading institutions, including MD Anderson and the University of Wollongong, as well as partnerships with major oncology research centres in Asia.
Race Oncology's dedication to advancing RC220 and its promising combination with doxorubicin could potentially provide a major breakthrough for patients with advanced solid tumours, offering an effective treatment option with reduced cardiotoxicity.
