RC220 Phase 1 Trial Expands: Hong Kong Site Now Enrolling Patients

Race Oncology’s Strategic Expansion into Hong Kong

Race Oncology Limited has taken a pivotal step in its clinical development program by activating its first Hong Kong trial site at Queen Mary Hospital for the Phase 1 study of RC220 in combination with doxorubicin. This milestone follows regulatory approval from the Hong Kong Department of Health, enabling the commencement of patient enrolment in a region with a robust healthcare infrastructure and significant commercial importance.

The Phase 1 trial aims to evaluate the safety, tolerability, pharmacokinetics, and the maximum tolerated combined dose of RC220 with doxorubicin in patients with advanced solid tumours. The trial’s expansion into Hong Kong is expected to accelerate recruitment, a critical factor given the cautious approach necessitated by the known cardiotoxic risks of doxorubicin in this vulnerable patient population.

Multi-Site Progress and Recruitment Dynamics

Alongside Queen Mary Hospital, the Prince of Wales Hospital in Hong Kong has secured ethics and regulatory approvals, with site activation anticipated shortly. This dual-site presence in Hong Kong, combined with ongoing recruitment in Australia and planned expansion into South Korea, is designed to broaden the patient pool and enhance the diversity of clinical data. To date, two patients have been treated at the Southside Cancer Care Centre in Australia, with 12 patients screened for eligibility.

Race Oncology’s CEO, Dr Daniel Tillett, highlighted the importance of these developments, noting the dedication of investigators and clinical teams and expressing optimism about the trial’s progress in Hong Kong. The company’s strategy reflects a recognition of the need to generate robust safety and efficacy data across different populations and healthcare settings.

Innovative Trial Design and Future Outlook

The Phase 1 trial employs a Bayesian design, which offers greater flexibility and efficiency compared to traditional clinical trial methodologies. After initial dose escalation and safety assessments in up to 33 patients, an additional cohort of 20 patients will be evaluated to further explore cardioprotective effects and anticancer efficacy signals. This approach underscores Race Oncology’s commitment to balancing patient safety with the urgent need for innovative cancer therapies.

Expanding the trial into East Asia not only facilitates faster recruitment but also provides critical insights into the drug’s performance in diverse patient populations, which is essential for future regulatory and commercial considerations. The inclusion of prominent clinical investigators in Hong Kong further strengthens the trial’s potential impact.