Race launches initial site for Phase I trial of a cardioprotective anticancer drug.

March 28, 2025 11:00 AM AEDT | By Team Kalkine Media

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Race launches initial site for Phase I trial of a cardioprotective anticancer drug. — Image source: shutterstock

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Highlights

Southside Cancer Care Centre in Miranda has been established as the initial site for the Phase I trial of RC220.

The trial includes participants with advanced solid tumors across Australia, Hong Kong, and South Korea.

RC220 is developed with cardioprotective properties, aiming to assess its safety and efficacy.

Healthcare Stock Race Oncology (ASX:RAC) has commenced its Phase I trial of RC220 at Southside Cancer Care Centre in Miranda, NSW. The trial investigates the combination of RC220 with doxorubicin for individuals diagnosed with advanced solid tumors. Ethics approval has been secured, and governance approval is the next step in the process before full trial activation.

Scope and Locations of the Trial
The Phase I trial follows an open-label design and is structured across multiple locations, including Australia, Hong Kong, and South Korea. Australian sites are expected to begin soon, with site activations managed by contract research organization George Clinical. Activation of sites in Hong Kong and South Korea is anticipated for a later stage due to regulatory timelines.

Focus on Safety and Pharmacokinetics
The primary objective of this trial is to analyze the safety, tolerability, and pharmacokinetics of increasing doses of RC220. Determining the maximum tolerated dose when combined with doxorubicin is a key aspect. Additionally, clinical biomarkers, such as m6A RNA, will be monitored throughout the study. Interim results will contribute to defining the optimal dosage and guiding further research into the cardioprotective and anticancer aspects of RC220.

Advancements in RC220 Development
RC220 is a reformulated version of bisantrene, an anthracene-based drug initially developed by Lederle Laboratories. This formulation has been designed to minimize cardiotoxicity while maintaining effectiveness. Previous complexities in administration limited its clinical application. The incorporation of a Bayesian trial design aims to enhance flexibility and efficiency in trial execution. Despite prior extensive research on bisantrene, a dose escalation phase remains a necessary step in this study to validate RC220’s safety and efficacy.

Progress and Future Steps
Race Oncology plans to provide ongoing updates on trial advancements while maintaining confidentiality regarding individual patient outcomes. CEO Dr. Daniel Tillett has emphasized the organization’s commitment to innovative approaches in oncology research, aiming to improve treatment options and clinical results. The study represents a significant step forward in addressing the needs of individuals affected by advanced solid tumors.

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