Race Oncology (ASX:RAC) has announced the successful and safe dosing of the first patient with RC220 in its Phase 1 clinical trial in advanced solid tumours.
The patient was treated by Professor Paul de Souza and his team at the study’s lead trial site, Southside Cancer Care Centre in Sydney. Race said no phlebitis (vein inflammation) or any other adverse events were reported.
CEO Dr Daniel Tillett said, “The safe dosing of the first patient in our solid tumour trial is a major milestone for Race Oncology and the beginning of an important program to assess the safety, tolerability and therapeutic potential of RC220. We are grateful to all the patients, investigators, and clinical teams who have made this trial possible. I would also like to thank our shareholders for their strong and loyal support that has enabled us to bring RC220 to patients in the clinic."
A second trial site at the Gosford and Wyong Hospitals has recently opened for patient enrolment.
Race’s Phase 1 solid tumour clinical trial is open-label and will be conducted across multiple sites in Australia, Hong Kong and South Korea. Stage 1 of the trial will use ascending doses of RC220 to determine the safety, tolerability, pharmacokinetics and maximum tolerated combined dose of RC220 in combination with doxorubicin in up to 33 patients.
Effects on a range of clinical biomarkers including m6ARNA will also be examined. Race said that after interim analysis of the data, the optimal dosage of RC220 in combination with doxorubicin will be assessed in an additional 20 patients in Stage 2 for further safety, tolerability, and preliminary cardioprotective and anticancer efficacy signals.