Race Oncology Ltd has executed a Work Order (WO) contract with Contract Research Organisation (CRO) George Clinical International to support the Phase 1 RAC-010 trial of RC220 bisantrene in combination with doxorubicin. The total contract value is A$8,582,117.
The study, conducted across sites in Australia, Hong Kong, and South Korea, aims to assess human safety and pharmacokinetics, establish the maximum tolerated combined dose, and provide initial clinical data on RC220’s cardioprotective, anticancer, and m6A RNA activity.
“This work order agreement with George Clinical is a significant milestone for Race. Bringing RC220 to the clinic as a new treatment to potentially protect patients from the heart damage caused by anthracyclines like doxorubicin, while also improving the treatment of their cancer is groundbreaking,” Race CEO, Dr Daniel Tillett said.
“I wish to thank George Clinical and the entire Race clinical team for their hard work and dedication in establishing this agreement.”
RC220 trial moves forward with George Clinical as CRO
Race has started its engagement with George Clinical under a WO Agreement for the RAC-010 Phase 1 trial, which covers all outsourced trial-related services, investigator grants, and pass-through costs for up to 53 patients across the dose escalation and dose expansion stages of the trial in Australia, Hong Kong, and South Korea. The final trial cost will be determined by patient recruitment numbers and other trial execution variables.
George Clinical is a leading global Contract Research Organisation (CRO) and brings over 20 years of operational experience and a strong track record in conducting oncology trials across all phases in the United States, Europe, China, South-East Asia, New Zealand, and Australia.
The RAC-010 Phase 1 trial will be an open-label, multi-site study in Australia, Hong Kong, and South Korea. It will use ascending doses of RC220 to evaluate safety, tolerability, pharmacokinetics, and the maximum tolerated combined dose (MTCD) when combined with doxorubicin. The trial will also assess RC220’s effects on clinical biomarkers, including m6A RNA. Following interim data analysis, the optimal dosage of RC220 in combination with doxorubicin will be further assessed in additional patients for safety, tolerability, and preliminary cardioprotective and anticancer efficacy signals. The trial will utilise a Bayesian design to enable greater flexibility and efficiency in trial execution.