Highlights
- RC220 clinical trial opens second site in Australia
- Phase 1 aims to assess safety, dosage, and efficacy
- Trial includes multiple global locations
Race Oncology (ASX:RAC) has expanded its ongoing Phase 1 clinical trial for RC220, a next-generation cancer therapy, by initiating patient enrolment at a second site in Australia. The new site, located within the Central Coast Local Health District and operating through Gosford and Wyong Hospitals, joins the already active lead site at Southside Cancer Centre in Miranda, New South Wales.
This development marks a key milestone for the company, as it aims to accelerate enrolment and deepen its understanding of RC220’s safety, pharmacokinetics, and potential clinical benefits. The Phase 1 study is designed to identify the maximum tolerated dose of RC220 when used in combination with doxorubicin—a widely used chemotherapy agent—and to offer early insights into RC220’s anticancer, cardioprotective, and m6A RNA-modulating effects.
RC220 is being tested in an open-label, multi-site trial that spans Australia, Hong Kong, and South Korea. This wide geographical scope supports faster data collection and diverse patient participation. The study's use of a Bayesian design allows for greater flexibility in trial execution and is expected to enhance the speed and adaptability of the research.
Stage 1 of the trial will evaluate ascending doses of RC220 in up to 33 patients to assess safety, tolerability, and pharmacokinetics. After analyzing interim data, an optimal dosage will be selected for further testing in Stage 2, which will involve 20 additional patients. This stage will focus on refining safety metrics and gathering preliminary data on RC220’s cardioprotective and anticancer effects.
Preclinical studies have already suggested that RC220, also known as bisantrene, may significantly boost the cancer-fighting potential of doxorubicin. The company’s screening of 143 cancer cell lines found enhanced activity in 85% of the cases. Moreover, a recent meta-analysis of doxorubicin treatment alone showed response rates of up to 35% in various advanced and metastatic solid tumours, including those affecting the breast, lung, bladder, liver, and other organs.
With regulatory approvals in place and momentum building across trial sites, Race Oncology (ASX:RAC) is strategically positioned to advance the development of RC220. The coming phases will be closely watched for their potential to unlock new approaches in solid tumour therapy.