Racura Oncology Opens Korean Recruitment for RC220 Phase 1 Solid Tumours Trial

Racura Oncology (ASX: RAC) has opened its first Korean site for patient enrolment in the Cardioprotection and Anticancer Synergy (CPACS) Phase 1 trial of RC220 with doxorubicin in people with advanced solid tumours.

The modified protocol requires patients to receive a cycle of doxorubicin alone before combination treatment, allowing investigators to compare baseline cellular damage after doxorubicin exposure with damage observed when RC220 is later given alongside the drug.

Ewha Womans University Seoul Hospital has been activated, with pre-screening already under way there and at Severance Hospital ahead of treatment of the first Korean patient.

Severance is scheduled to open for recruitment on 4 September and Samsung Medical Center on 8 September, while Asan Medical Center has all regulatory and governance approvals and is awaiting execution of its study contract.

Racura expects the additional Korean sites to increase recruitment capacity and accelerate trial progress by broadening the number of clinicians and patients able to participate.

Korean Recruitment Network

The Korean expansion adds major oncology centres to a trial already operating in Australia and Hong Kong, giving Racura an opportunity to assess RC220 safety and efficacy across different clinical practices and patient populations.

Opening the sites took longer than initially anticipated because protocol changes supporting a blood-based cardioprotection biomarker required fresh approval from Korea’s Ministry of Food and Drug Safety and independent ethics and governance approvals at each site.

“Activating the CPACS trial sites in Korea is an important milestone for Racura,” chief executive officer Dr Daniel Tillett said.

We appreciate the dedication and enthusiasm of these world-class investigators and clinical teams participating in this trial, [and] look forward to enrolling and treating the first patient with RC220 in Korea in the near future.”

Protocol Dose Escalation

The upfront doxorubicin cycle is also intended to identify patients unable to tolerate the drug before they are exposed to RC220, reducing the risk that toxicities caused by doxorubicin are incorrectly attributed to the investigational treatment.

Racura has already established that 40mg/m2 of RC220 with doxorubicin is safe in the CPACS trial, while Cohort 2 is testing whether the combination remains tolerable when the RC220 dose is increased to 80mg/m2.

Once Cohort 2 is complete, the Safety Review Committee will assess the available safety and tolerability data, and either allow escalation to a 160mg/m2 RC220 cohort or end dose escalation and move the trial into its efficacy stage using the highest tolerated dose.

Each patient requires four safety assessments across three treatment cycles over about five months, meaning recruitment speed will continue to depend on screening, eligibility, site readiness, and treatment-slot availability even as the Korean network expands.