Race Oncology Hits Key Milestone in RC220 Clinical Trial

Highlights

• First patient dosed with RC220 + doxorubicin in Phase 1 trial
• Trial targets reduced cardiotoxicity in advanced solid tumours
• Global sites and strong preclinical backing boost momentum

Race Oncology (ASX:RAC) has reached a major clinical development milestone with the first patient dosed in its Phase 1 trial of RC220 combined with doxorubicin for advanced solid tumours. Administered at the Southside Cancer Care Centre in Miranda, New South Wales, the successful dosing was completed without any treatment-related dose-limiting toxicities, indicating a positive early safety profile.

The clinical trial aims to assess the safety, tolerability, and anticancer potential of RC220 when paired with doxorubicin — a widely used chemotherapy drug known for its efficacy across various cancers but limited by serious cardiotoxic side effects. RC220’s formulation is designed to reduce such risks, potentially expanding the safe application of doxorubicin-based therapies.

Robust Trial Framework and Patient-Centric Design

The ongoing trial is structured in two stages. In the first phase, up to 33 patients will receive ascending doses of the RC220-doxorubicin combination to establish the maximum tolerated dose (MTD). Once identified, a second group of 20 patients will be enrolled to further evaluate safety and potential anticancer activity. The study also integrates analysis of key biomarkers, such as m6A RNA, to support targeted treatment development.

A Bayesian adaptive trial design enables faster and more flexible protocol adjustments based on interim results, helping streamline the development pathway.

Expanding Global Footprint with Strategic Collaborations

The trial is being conducted at multiple sites in Australia, with additional activation efforts underway in Hong Kong and South Korea. Race Oncology is strategically expanding its global clinical footprint while continuing to collaborate with renowned research institutions including the University of Wollongong and MD Anderson.

Notably, this marks the second significant milestone in the broader RC220 development program, following the first successful solo dosing of RC220 in May.

RC220 has demonstrated strong promise in preclinical studies, where its active compound, bisantrene, improved doxorubicin’s cancer-fighting ability in 85% of the 143 cancer cell lines tested. Doxorubicin on its own has shown response rates of up to 35% in tumour types such as breast, ovarian, and lung cancer.

By combining strong preclinical validation, strategic global trials, and a novel cardioprotective cancer therapy, Race Oncology (RAC) continues to move toward potentially transformative treatment options for patients with advanced solid tumours.