Race Initiates First AU Site for Phase 1 Solid Tumour Trial
| Stock | Race Oncology Ltd (RAC.ASX) |
|---|---|
| Release Time | 27 Mar 2025, 3:53 p.m. |
| Price Sensitive | Yes |
Race Initiates First AU Site for Phase 1 Solid Tumour Trial
- Lead Australian trial site, Southside Cancer Care Centre, initiated for Race's clinical trial of RC220 in advanced solid tumours
- Up to 53 patients to be enrolled across multiple sites in Australia, Hong Kong and South Korea
- Study will evaluate safety, pharmacokinetics, maximum tolerated combined dose of RC220 with doxorubicin, and initial clinical data on cardioprotective, anticancer and m6A RNA activity of RC220
Race Oncology Limited (Race) has announced the initiation of Southside Cancer Care Centre in Miranda, NSW, as the first Australian clinical site in preparation for the commencement of patient enrolment for its Phase 1 clinical trial of RC220 in combination with doxorubicin in advanced solid tumours patients. Site initiation follows the receipt of ethics approval for the trial this month, and Race now awaits governance approval as the final step to activate the site for commencing patient recruitment. The Phase 1 trial is a two-stage open-label study to be conducted across multiple sites in Australia, Hong Kong and South Korea. The trial will investigate ascending doses of RC220 to determine the safety, tolerability, pharmacokinetics, maximum tolerated combined dose (MTCD) with doxorubicin, and effects on a range of clinical biomarkers including m6A RNA. After interim analysis of the data from Stage 1 of the trial, the optimal dosage of RC220 in combination with doxorubicin will be assessed in additional patients for further safety, tolerability, cardioprotective and anticancer efficacy signals. The Phase 1 trial will use a Bayesian design enabling greater trial flexibility and speed than other approaches.