
Racura Oncology cleared to double RC220 trial dosage
Racura Oncology (ASX:RAC) announced a milestone in its Phase 1 CPACS clinical trial, receiving formal clearance to escalate the dosage of its lead candidate, RC220.
Following a data review by the Safety Review Committee, the trial is set to transition from Cohort 1 to Cohort 2, doubling the RC220 dose from 40mg/m2 to 80mg/m2.
The SRC’s decision comes after evaluating the safety and pharmacokinetic profiles of the initial patient group, all of whom presented with advanced metastatic solid tumours.
The committee reported an absence of dose-limiting toxicities, even when RC220 was administered alongside the standard-of-care chemotherapy agent, doxorubicin.
Racura CEO Dr Daniel Tillett expressed strong optimism, noting that the safety profile observed thus far is "highly encouraging" given the advanced nature of the patients' conditions.
Under an updated trial protocol, Cohort 2 will incorporate an initial lead-in safety monotherapy cycle of doxorubicin before RC220 administration.
The adjustment allows researchers to utilise a blood-based molecular test to specifically assess RC220’s anthracycline cardioprotective potential—a key objective of the trial.
Screening for new participants is currently active across clinical sites in Australia, Hong Kong, and South Korea.
As the trial progresses, existing patients from the first cohort will be transitioned to the updated protocol to ensure consistency in data collection regarding the drug’s ability to protect the heart during intensive anticancer treatment.
At the time of reporting, Racura Oncology’s share price was $2.86.