Racura Oncology (ASX:RAC) has received clearance from its Safety Review Committee (SRC) to escalate the RC220 dose to 80mg/m2 in the Phase 1 CPACS trial following a review of safety and pharmacokinetic data from the first cohort.
The SRC found no treatment-related safety concerns and no dose-limiting toxicities among the three patients enrolled at 40mg/m2. Racura noted that all patients on trial remain alive despite advanced metastatic disease at enrollment. Patient screening to enrol new participants in Australia, Hong Kong and South Korea is underway as the study moves to Cohort 2 using an updated protocol.
The revised protocol introduces an initial lead-in safety monotherapy cycle of doxorubicin prior to RC220 to enable assessment of cardioprotection using a blood-based molecular test. Cohort 1 patients still receiving treatment will transition to the updated protocol for future cycles. The SRC reviewed data from patients treated with RC220 alone at 40mg/m2, followed by up to 6 combination cycles of RC220 at 40mg/m2 with doxorubicin at the standard-of-care dose of 60mg/m2.
Racura CEO and Managing Director Dr Daniel Tillett said, “I am extremely proud of the Racura team and our clinical collaborators for reaching this important milestone. The safety seen to date with RC220 in advanced cancer patients, including the absence of dose-limiting toxicities even when combined with a standard of care doxorubicin dose, is highly encouraging. Finally, we wish to thank the patients and their families for their courage and generosity shown by participating in the CPACS trial.”