Racura Oncology Ltd Wins Ethics Approval for More Lung Trial Sites
Bellberry ethics approval clears the way for new HARNESS-1 lung cancer trial sites
Racura Oncology (ASX: RAC) has received Bellberry Human Research Ethics Committee (HREC) approval for its HARNESS-1 lung cancer clinical trial, clearing the way for additional Australian sites to activate. The approval follows the earlier St Vincent’s Hospital (Melbourne) HREC approval for lead site Monash Health, announced 26 November 2025.
Announced on 3 July 2026, the milestone means Chris O’Brien Lifehouse and Austin Health will now progress to governance and start-up activities. HARNESS-1 evaluates RC220 (E,E-bisantrene) in combination with osimertinib (Tagrisso®, AstraZeneca) in patients with EGFR-mutant non-small cell lung cancer (EGFRm NSCLC). More activated sites means faster patient access and stronger enrolment momentum for this Phase 1a/b program.
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What the approval unlocks
The Bellberry ethics approval applies to Australian private hospital sites and eligible public hospital sites outside Victoria. Chris O’Brien Lifehouse will now progress to governance and start-up activities under this approval.
Separately, St Vincent’s Hospital (Melbourne) HREC has approved the inclusion of Austin Health (Victoria), which will also proceed to governance and start-up. Additional Australian sites are expected to be added over the coming months as further governance approvals are received.
HARNESS-1 reached another milestone on 25 June 2026 when the first patient dosed at Monash Health received RC220 at the 50mg/m2 starting dose with no adverse events observed, confirming the trial had moved from administrative readiness into active treatment.
Current site status across the study:
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Monash Health — lead site, previously approved (St Vincent’s Melbourne HREC, 26 Nov 2025)
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Chris O’Brien Lifehouse — progressing to governance/start-up
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Austin Health (Victoria) — approved for inclusion, progressing to start-up
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Additional sites — expected over coming months
Dr. Rodney Cusack, Principal Scientist
“This additional HREC approval is another important milestone for the HARNESS-1 clinical program. Chris O’Brien Lifehouse and Austin Health are highly regarded cancer care centres with the clinical expertise and patient access needed to support the study. With these approvals secured, we look forward to activating both sites and advancing enrolment as we continue evaluating RC220 in combination with osimertinib.”
Understanding HARNESS-1 and why it matters
HARNESS-1 is a multi-centre Phase 1a/b clinical study in patients with EGFR-mutant NSCLC who are receiving osimertinib. The observational screening stage uses circulating tumour DNA (ctDNA), a blood-based marker of cancer activity and growth, to help identify and enrol patients eligible for the treatment stage.
The study follows a two-stage design. The first treatment stage tests increasing intravenous doses of RC220 on Day 1 of each 21-day cycle, alongside standard-of-care maintenance osimertinib. This dose-escalation stage is designed to assess safety while efficiently identifying an appropriate dose, with 12 to 40 patients expected to participate.
Once a recommended dose is established and reviewed against safety and PK data, the study moves into a double-blind, randomised Phase 1b expansion stage. In this stage, 40 patients will receive one of two RC220 dose levels in combination with osimertinib, monitored for safety, PK and early signals of clinical activity, including progression-free survival, overall survival, changes in ctDNA levels and changes in cancer-specific mutations.
| Stage | Design | Patient Numbers | Dosing | Key Endpoints |
|---|---|---|---|---|
| Dose-escalation | Dose-escalation | 12–40 | Increasing RC220 IV, Day 1 of 21-day cycle + osimertinib | Safety, PK, dose selection |
| Phase 1b expansion | Double-blind, randomised | 40 | Two RC220 dose levels + osimertinib | PFS, OS, ctDNA, mutation changes |
For investors, each activated site helps accelerate enrolment and de-risks the pathway toward the expansion stage of the program.
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The bigger picture for Racura investors
RC220 is a proprietary formulation of (E,E)-bisantrene, sitting within a broader pipeline that includes a Phase 3 clinical program in acute myeloid leukaemia (AML), this Phase 1a/b program in EGFRm NSCLC, and a Phase 1a/b program in combination with the anthracycline doxorubicin. According to the company, (E,E)-bisantrene primarily functions via G4-DNA and RNA binding, leading to potent silencing of the cancer growth regulator MYC, and has demonstrated therapeutic activity in cancer patients with a well-characterised safety profile.
Recent discoveries have enabled composition of matter IP filings that provide for 20 years of patent protection over (E,E)-bisantrene. Racura has stated it is actively exploring partnerships, licence agreements, or a commercial merger or acquisition to accelerate access to RC220 for patients with cancer across the world.
Near-term steps centre on activating Chris O’Brien Lifehouse and Austin Health, alongside further site additions in the coming months, to drive enrolment. Trial details, including open and recruiting sites, are available on the Australian and New Zealand public clinical trial registry (ANZCTR) under trial code ACTRN12626000325303.
For investors exploring the clinical de-risking milestones that preceded this ethics expansion, our detailed coverage of the first HARNESS-1 patient recruitment at Monash Health outlines the Bayesian Optimal Interval dose escalation design, its alignment with FDA Project Optimus, and what each additional activated site means for enrolment timelines.
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