Patient enrolment at Southside Cancer Care Centre in Miranda, New South Wales has started marking the activation of Race Oncology Ltd’s lead Australian site for the Phase 1 clinical trial of RC220 in combination with doxorubicin for patients with advanced solid tumours.
The open-label, multi-centre study is designed to assess human safety and pharmacokinetic data, determine the maximum tolerated combined dose (MTCD) of RC220 and doxorubicin, and deliver early clinical insights into RC220’s cardioprotective, anticancer and N6-methyladenosine (m6A) RNA-modifying activity.
Following ethics approval and site initiation in March 2025, the Miranda centre is now fully authorised to recruit patients. The trial will be conducted across sites in Australia, Hong Kong and South Korea, using a Bayesian adaptive design to enhance efficiency and flexibility.
“I am proud of the hard work and dedication from the Race clinical team, George Clinical and CCF in reaching this point. I look forward to soon treating the first patient with RC220 and beginning the process of advancing RC220 as a potential new treatment able to improve cancer therapy while protecting patients from the serious side effects of cancer treatment,” Race CEO, Dr Daniel Tillett said.
Evaluating tolerability and safety
Up to 33 patients will receive ascending doses of RC220 to evaluate tolerability, safety, and biomarker responses. A further 20 patients will be enrolled in an expansion cohort following interim analysis to explore optimal dosing and preliminary efficacy.
Race Oncology’s preclinical research indicates RC220 enhances the cancer-killing activity of doxorubicin in 85% of 143 cancer cell lines tested. Complementing this, the company’s meta-analysis of doxorubicin monotherapy revealed response rates of up to 35% in a range of advanced and metastatic cancers.
Enrolment timing for individual patients will depend on their eligibility and willingness to participate in the trial.