Racura Oncology has launched patient enrolment at its first Korean site for the CPACS Phase 1 trial, aiming to accelerate recruitment and validate RC220’s safety and efficacy in a key oncology market.
- First Korean site Ewha Womans University Seoul Hospital activated
- Severance and Samsung Medical Centers to open early September
- Protocol amended to include doxorubicin monotherapy for safety
- Korean sites ranked among world’s top oncology hospitals
- Expansion expected to speed enrolment and diversify clinical data
Korean Site Activation Marks Strategic Trial Expansion
Racura Oncology (ASX:RAC) has taken a significant step in its CPACS Phase 1 trial by activating Ewha Womans University Seoul Hospital as the first Korean site for patient enrolment. This move opens the door to tapping into South Korea’s world-class oncology infrastructure, with two additional sites; Severance Hospital and Samsung Medical Center; scheduled to begin enrolment in early September. A fourth site, Asan Medical Center, awaits final contract execution.
The Korean centres are highly regarded internationally, with Samsung and Asan ranked third and fourth globally in oncology by Newsweek in 2026, and Severance Hospital placed 22nd. This calibre of clinical partners is expected to enhance recruitment speed and provide robust data across diverse patient populations, particularly valuable given the differences in clinical practice and genetics between regions.
Protocol Changes Enhance Patient Safety and Data Clarity
The trial protocol was recently modified to include a doxorubicin monotherapy cycle before combination treatment with Racura’s RC220. This adjustment addresses a critical challenge in oncology trials involving doxorubicin, a widely used chemotherapy agent with highly variable patient tolerance.
Doxorubicin metabolism can differ more than tenfold between individuals, leading to severe side effects in up to 40% of patients at standard doses. By administering doxorubicin alone initially, investigators can identify patients unable to tolerate the drug and exclude them from the combination treatment phase, thereby improving patient safety and preventing toxicities from being wrongly attributed to RC220. This change also introduces a blood-based biomarker to measure cardioprotection, aiming to demonstrate whether RC220 shields normal cells from doxorubicin damage.
Trial Progress and Future Milestones
Pre-screening has already begun at Ewha and Severance, with the first Korean patient expected to start treatment imminently, subject to eligibility and treatment slot availability. The CPACS trial’s dose-escalation phase is currently evaluating whether 80mg/m2 of RC220 can be safely combined with doxorubicin, building on prior findings that 40mg/m2 is safe and effective in preclinical models.
Following completion of Cohort 2, the Safety Review Committee will assess the data to decide whether to proceed to a higher dose cohort or transition into the efficacy phase using the highest tolerated dose. These steps are critical to optimising dosing strategies that maximise both cardioprotection and anticancer activity, which in turn could shape the success of later-stage trials.
Racura’s CEO, Dr Daniel Tillett, highlighted the importance of activating Korean sites, acknowledging the dedication of the clinical teams and the strategic value of expanding into a commercially significant market. This expansion aligns with Racura’s broader clinical development program, which includes ongoing trials in acute myeloid leukaemia and EGFR-mutated lung cancer, supported by a strong cash position reported recently.
Bottom Line?
Korean site activations in the CPACS trial could accelerate patient enrolment and provide critical safety data, but the pace of progress will depend on patient eligibility and Safety Review Committee decisions following dose escalation.
Questions in the middle?
- Will Korean patient enrolment rates meet expectations to shorten trial timelines?
- How will the new biomarker data influence the assessment of RC220’s cardioprotective effects?
- What impact will trial findings in Korea have on Racura’s commercial strategy in Asia?