Race Oncology Ltd (ASX:RAC, OTC:RAONF) earlier this week announced the activation of its first clinical site in Hong Kong for the Phase 1 trial of RC220 in combination with doxorubicin. The site, located at Queen Mary Hospital, enables the start of patient enrolment in the region. The company said screening is underway and the first patient is expected to begin treatment this month. CEO Dr Daniel Tillett told Proactive, the activation of the first trial site in Hong Kong marks a key development for the company. “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,” he said.
Highlights
- Race Oncology has activated its first Hong Kong clinical trial site at Queen Mary Hospital.
- The trial is a Phase 1 study of RC220 combined with doxorubicin in advanced solid tumours.
- Screening is underway, with the first Hong Kong patient expected to begin treatment in September.
- A second site at Prince of Wales Hospital is approved and due for activation shortly.
- Two patients have already been treated in Australia, with 12 assessed for inclusion.
- The trial is open-label and multi-regional, running in Australia, Hong Kong, and South Korea.
- Stage 1 will enrol 33 patients for dose escalation; Stage 2 adds 20 more to refine dosing.
- The study is designed to assess safety, tolerability, pharmacokinetics, and early biomarker responses.
- A Bayesian design is used to allow greater flexibility and data-driven decision-making.
Potential treatment for advanced solid tumours
Race Oncology's trial is investigating RC220 as a potential treatment for advanced solid tumours. It is designed to assess safety, tolerability, and pharmacokinetics, and to establish the maximum tolerated dose when used in combination with doxorubicin.
Race said a second site at Prince of Wales Hospital has also received ethics and regulatory approvals. Site activation is expected in the coming weeks, expanding the company’s capacity for recruitment in Hong Kong.
In Australia, two patients have already been treated at the Southside Cancer Care Centre in New South Wales. A total of 12 patients have been assessed for inclusion. The company noted that recruitment has been cautious due to the added risks from doxorubicin in patients with advanced disease. However, it expects enrolment to accelerate with the addition of new sites in both Hong Kong and South Korea.
20 patients for stage 2
The trial is structured as an open-label, multi-centre Phase 1 study. Stage 1 will enrol up to 33 patients to evaluate safety parameters and determine the maximum tolerated combined dose. Following interim analysis, Stage 2 will enrol a further 20 patients to explore the optimal RC220–doxorubicin dosage and assess its effect on biomarkers related to cardioprotection and anticancer activity.
Dr Tillett highlighted that the trial uses a Bayesian design, which offers greater flexibility and responsiveness than traditional trial methods. This approach allows more adaptive decision-making based on real-time data, potentially improving the trial’s efficiency.