Race Oncology Ltd (ASX:RAC, OTC:RAONF) has activated its first Hong Kong clinical site at Queen Mary Hospital, enabling patient enrolment for the Phase 1 trial of RC220 in combination with doxorubicin in advanced solid tumours. Screening has commenced, with the first Hong Kong patient expected to begin treatment this month.
The Phase 1 study is designed to evaluate the safety, tolerability and pharmacokinetics of RC220, as well as determine the maximum tolerated combined dose with doxorubicin. Prince of Wales Hospital in Hong Kong has also secured ethics and regulatory approvals, with site activation scheduled in the coming weeks. This will establish a second Hong Kong recruitment site.
“Activating the first RC220 trial site in Hong Kong for our solid tumour study is a key milestone for Race Oncology," Race CEO Dr Daniel Tillett said.
"We appreciate the dedication of the investigators, clinical teams and patients participating in the trial. We look forward to the first patient being treated in Hong Kong.”
Patients already treated in Australia
In Australia, two patients have already been treated with RC220 at the Southside Cancer Care Centre in Miranda, New South Wales. To date, 12 patients have been assessed for inclusion.
Recruitment is proceeding cautiously due to the additional risks posed by doxorubicin in advanced disease. However, the company expects patient enrolment to accelerate as new sites open in Hong Kong and South Korea, broadening the eligible patient pool.
About the trial
Race’s Phase 1 solid tumour trial is an open-label study conducted across multiple sites in Australia, Hong Kong and South Korea.
Stage 1 will enrol up to 33 patients who will receive escalating doses of RC220 in combination with doxorubicin. The aim is to evaluate safety, tolerability, and pharmacokinetics and to determine the maximum tolerated combined dose (MTCD). The study will also investigate the effect of treatment on clinical biomarkers.
Following interim analysis, Stage 2 will assess the optimal RC220–doxorubicin dosage in an additional cohort of 20 patients. This phase will further evaluate safety, tolerability, and provide early insights into both cardioprotective and anticancer activity.
The trial uses a Bayesian design, offering greater flexibility and efficiency than traditional approaches.