Race Oncology Ltd has initiated its first Australian clinical site for a Phase 1 trial testing a reformulated version of its lead cancer drug, RC220, in patients with advanced solid tumours.
The site, Southside Cancer Care Centre in Miranda, New South Wales, is the first to be set up for the trial, which will eventually run across locations in Australia, Hong Kong and South Korea. Governance approval is still pending before patient recruitment can begin.
The study will enrol up to 53 patients and test RC220 in combination with doxorubicin, a widely used chemotherapy drug known for its effectiveness as well as its potential to cause heart damage.
Maximum tolerated dose
The key aims are to determine the maximum tolerated dose of the drug combination and gather early data on safety, how the drug behaves in the body (known as pharmacokinetics), and any impact on cancer progression or heart health.
The open-label nature of the trial (meaning both researchers and participants know which treatment is being given) allows for quicker readouts of patient outcomes. The trial will also assess RC220’s effects on the m6A RNA pathway, a process increasingly seen as relevant to cancer development.
Race is using a Bayesian trial design, which allows for more flexibility and faster decision-making than traditional clinical approaches.
Chief executive Daniel Tillett said the milestone marked an important step towards beginning patient enrolment. “Southside Cancer Care Centre serves as our lead trial site in Australia.
“Initiation of our lead site moves us closer to launching our Phase 1 trial and, ultimately to our mission of providing new hope for those fighting cancer.”
New formulation
RC220 is a new formulation of bisantrene, a chemotherapy compound originally developed decades ago but never widely adopted. Race is positioning it as a potential alternative to traditional anthracyclines like doxorubicin, with the goal of maintaining anticancer efficacy while reducing heart-related side effects.
The trial will proceed in two stages, with the first focused on dose escalation. Once the appropriate dose is identified, additional patients will be enrolled to gather further safety data and early signs of whether the drug is helping shrink tumours or protect the heart.
Race said it would provide regular updates on trial progress, though not at the level of individual patient results.
The company is also exploring other uses for RC220, including in acute myeloid leukaemia, and has partnerships with a range of international research institutions.