Racura Completes First Dose Cohort With Zero Safety Issues in Cancer Trial
Racura Oncology completes first dose cohort in RC220 clinical trial
Racura Oncology (ASX: RAC) has announced the successful dosing of the third patient in its RC220 Clinical Trial, completing recruitment of the initial dose cohort in the CPACS Phase 1 trial. The patient was treated at Queen Mary Hospital in Hong Kong at a dose level of 40mg/m², with no phlebitis or adverse events reported. Across all three patients dosed to date, no dose-limiting toxicities have been observed.
The completion of this first cohort triggers a Safety Review Committee (SRC) assessment, which will determine whether the trial can progress to the next dose level of 80mg/m². This represents a de-risking milestone for the clinical programme, as the clean safety profile observed thus far supports continued dose escalation in the study.
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What is RC220 and why does cardioprotection matter?
RC220 is a proprietary formulation of (E,E)-bisantrene, a small molecule anticancer agent that primarily functions via G4-DNA and RNA binding, leading to potent inhibition of the important cancer growth regulator MYC. The CPACS trial is testing RC220 in combination with doxorubicin, an anthracycline chemotherapy, with the aim of achieving both cardioprotection and enhanced anticancer activity.
Anthracyclines like doxorubicin are effective cancer treatments, but their use is limited by cumulative heart damage. This toxicity can force doctors to reduce doses or discontinue treatment entirely, potentially compromising patient outcomes. If RC220 can protect the heart whilst improving anticancer efficacy, it addresses a significant unmet need across multiple solid tumour types, expanding the potential market opportunity for the therapy.
Next steps: dose escalation to 80mg/m²
The Safety Review Committee will now assess accumulated safety data from all three patients in the first cohort. Subject to SRC clearance, the trial will advance to the next dose level of 80mg/m², using the updated protocol announced on 11 February 2026. Recruitment for the next cohort will expand across multiple sites in Australia, Hong Kong, and South Korea.
Upcoming milestones:
- Safety Review Committee review of first cohort data
- Progression to 80mg/m² dose cohort (subject to SRC clearance)
- Multi-site recruitment across three countries
The expansion to multiple sites is expected to accelerate patient enrolment and data generation, potentially shortening the timeline to identifying the maximum tolerated combined dose.
CPACS trial structure and design
The CPACS trial is an open-label Phase 1 study structured in two stages. Stage 1 uses ascending doses of RC220 to determine safety, tolerability, pharmacokinetics, and the maximum tolerated combined dose (MTCD) of RC220 in combination with doxorubicin in up to 33 patients. Effects on a range of clinical biomarkers, including a blood-based measure of the cardioprotective mechanism of action of RC220, will also be examined.
Following interim analysis, Stage 2 will assess the optimal dosage of RC220 in combination with doxorubicin in an additional 20 patients to evaluate further safety, tolerability, and preliminary cardioprotective and anticancer efficacy signals. The trial employs a Bayesian design, enabling greater trial flexibility and speed.
| Trial Stage | Focus | Patient Numbers | Key Endpoints |
|---|---|---|---|
| Stage 1 | Dose escalation | Up to 33 | Safety, tolerability, MTCD |
| Stage 2 | Efficacy signals | Additional 20 | Cardioprotective and anticancer activity |
Because the trial is open-label, patient outcomes will be obtained soon after treatment, allowing the company to provide regular progress updates. The Bayesian design allows faster adaptation based on emerging data, potentially accelerating the path to efficacy signals and subsequent clinical development phases.
Management commentary
Dr Daniel Tillett, Chief Executive Officer
“The safe dosing of the third patient in our RC220 solid tumour trial in Hong Kong and recruitment of the first dose escalation cohort is an important milestone for Racura Oncology. We are grateful to all the patients, investigators, and clinical teams who have made this trial possible and we look forward to treating patients on the updated protocol.”
Dr Tillett’s comments frame the completion of the first cohort as validation of clinical progress to date. Racura has stated it intends to provide regular trial updates but will not report at the individual patient level.
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Racura’s broader RC220 pipeline
RC220 is being tested across multiple indications, diversifying clinical risk and expanding potential commercial applications. Racura’s three active clinical programmes are:
- Phase 3 in acute myeloid leukaemia (AML), where RC220 has already progressed to late-stage development
- Phase 1a/b in mutant EGFR non-small cell lung cancer (EGFRm NSCLC), targeting a molecularly defined patient population
- Phase 1a/b CPACS trial in solid tumours, the subject of this announcement, exploring cardioprotection in combination with anthracyclines
The company is actively exploring partnerships, licence agreements, or merger and acquisition opportunities to accelerate patient access to RC220. This portfolio approach allows Racura to pursue multiple value-creation pathways simultaneously whilst managing the inherent risks of single-asset biotechnology development.
The clean safety profile observed in the first CPACS cohort, combined with the trial’s expansion across multiple sites, positions Racura to generate meaningful clinical data over the coming quarters. The progression to higher doses will provide critical information about RC220’s tolerability and preliminary efficacy signals when combined with doxorubicin.
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