Highlights

  • Racura Oncology has opened its first Korean site for the CPACS Phase 1 trial of RC220 with doxorubicin.
  • Ewha Womans University Seoul Hospital is now activated for patient enrolment, with pre-screening already underway.
  • Severance Hospital and Samsung Medical Center are scheduled to open for recruitment on 4 and 8 September 2026, respectively.
  • Asan Medical Center has received regulatory and governance approvals and is awaiting final study-contract execution.
  • The company expects additional Korean sites to increase recruitment capacity and support trial progress.

Racura Oncology Ltd (ASX:RAC) has expanded its CPACS Phase 1 clinical trial into South Korea, with Ewha Womans University Seoul Hospital activated as the first Korean site able to enrol patients into the study of RC220 in combination with doxorubicin for advanced solid tumours.

Racura shares were trading at AUD 2.21, up 3.76%, during the morning session on 1 September 2026. The stock remained up 76.80% over the past year.

The Korean expansion adds several oncology centres to the CPACS trial network and is intended to increase patient recruitment capacity as Racura progresses development of RC220, its proprietary formulation of (E,E)-bisantrene.

Korean Enrolment Begins

Pre-screening of patients has begun at Ewha Womans University Seoul Hospital and Severance Hospital.

Racura said treatment of the first Korean patient is expected soon, subject to patient eligibility and the availability of an open treatment slot.

Severance Hospital is scheduled to open for recruitment from 4 September 2026, while Samsung Medical Center is expected to begin enrolment from 8 September.

The final Korean site, Asan Medical Center, has already received regulatory and governance approvals. Activation is now awaiting execution of the study contract by the relevant institutional personnel.

The company expects the addition of Korean sites to increase the number of clinicians and patients able to participate in the study, although recruitment timing will continue to depend on screening, eligibility and treatment-slot availability.

Why Korea Matters

Racura said there were three main reasons for opening the additional trial sites in South Korea.

The first is investigator interest in the CPACS study and the challenge of reducing cardiotoxicity associated with anthracycline chemotherapy such as doxorubicin.

The second is recruitment capacity. Adding more trial locations increases the potential patient pool and may improve the speed at which eligible participants can be enrolled.

The third is geographic Diversification of clinical data. Expanding into Korea gives Racura the opportunity to assess RC220 in patient populations and clinical settings outside Australia and Hong Kong.

The company also sees Korea as a commercially relevant pharmaceutical market for future development.

Protocol Changes Delayed Activation

The Korean site rollout took longer than initially anticipated because Racura modified the CPACS trial protocol to incorporate a blood-based biomarker of cardioprotection.

Those changes required the revised protocol to be resubmitted to South Korea’s Ministry of Food and Drug Safety and then separately reviewed by the Institutional Review Boards at each participating hospital.

The updated protocol introduces an initial cycle of doxorubicin monotherapy before patients receive RC220 in combination with doxorubicin.

This allows investigators to collect baseline data on cellular damage caused by doxorubicin alone and compare it with later measurements taken when RC220 is added.

Racura said the approach is intended to show whether RC220 can reduce normal-cell damage associated with doxorubicin treatment.

Patient Safety in Focus

The protocol change also has a safety rationale.

Racura said patient tolerance to doxorubicin can vary widely because metabolism of the drug differs substantially between individuals.

At the standard-of-care dose of 60mg/m2, some patients may experience limited side effects while others can be exposed to more toxic drug levels.

The company noted that there is currently no reliable test capable of predicting doxorubicin metabolism for individual patients before treatment.

By introducing an upfront doxorubicin-only cycle, trial investigators can identify patients who do not tolerate the drug before exposing them to the RC220 and doxorubicin combination.

Racura said this reduces the risk that toxicities caused by doxorubicin are incorrectly attributed to RC220 during the dose-escalation stage.

Cohort 2 Becomes Key

The current phase of the CPACS trial is focused on whether 80mg/m2 of RC220 can be safely combined with doxorubicin.

Racura has already established that 40mg/m2 of RC220 with doxorubicin is safe, based on an earlier trial update released on 15 May 2026.

The company said this lower dose demonstrated both cardioprotection and additional anticancer activity in preclinical models.

If 80mg/m2 is found to be tolerable, the trial may progress to Cohort 3, where a 160mg/m2 RC220 dose would be assessed.

If the 80mg/m2 dose exceeds the permitted dose-limiting toxicity threshold, the dose-escalation stage would end and the efficacy stage would begin using the highest tolerated dose.

The available safety and tolerability data will be reviewed by the Safety Review Committee after Cohort 2 is completed.

Longer Patient Assessment

Patient enrolment in the CPACS trial is deliberately structured around multiple safety checks.

Participants must first pass screening and eligibility requirements before receiving doxorubicin monotherapy.

They are then assessed after doxorubicin alone, after RC220 monotherapy, and again after the first cycle of the combination treatment.

Racura said these four safety assessments and three treatment cycles take approximately five months to complete for each patient.

This means trial progress depends not only on enrolment numbers, but also on how quickly individual patients can complete the staged treatment and safety-review process.

RC220 Development Strategy

RC220 is Racura’s proprietary formulation of (E,E)-bisantrene.

The company is developing the asset across several oncology programs, including the EMILI Phase 3 trial in acute myeloid leukaemia, the HARNESS Phase 1a/b study in combination with osimertinib for EGFR-mutated non-small cell lung cancer, and the CPACS Phase 1a/b study with doxorubicin.

Within CPACS, Racura is seeking to investigate both anticancer activity and protection against anthracycline-related cardiotoxicity.

The company said preclinical data suggest the cardioprotective and anticancer effects of RC220 may increase with dose, which is why determining the maximum tolerated dose remains an important part of the study.

Management Commentary

Chief Executive Officer and Managing Director Dr Daniel Tillett described activation of the Korean CPACS sites as an important clinical milestone.

He acknowledged the investigators and clinical teams involved and said Racura was looking forward to treating the first Korean patient with RC220.

The company said future investor updates will be provided once the Safety Review Committee has reviewed all Cohort 2 patient data and determined whether the study should proceed to Cohort 3 or transition into the efficacy stage.

What Investors May Be Watching

The immediate focus is likely to be the treatment of the first Korean patient and activation of the remaining sites during September.

Investors may also watch the pace of recruitment across Ewha, Severance, Samsung Medical Center and eventually Asan Medical Center, as the broader network is intended to improve access to eligible patients.

The next major clinical decision point will come after Cohort 2, when the Safety Review Committee determines whether RC220 can move to the 160mg/m2 dose or whether the trial should proceed directly into the efficacy stage at the highest tolerated dose.

The Korean expansion increases recruitment capacity, but the company has made clear that enrolment will still depend on patient eligibility, screening, safety assessments and open treatment slots.