Racura Oncology has secured Bellberry HREC approval for its HARNESS-1 lung cancer trial, enabling expansion to additional Australian sites including Chris O’Brien Lifehouse and Austin Health, setting the stage for accelerated patient enrolment.
- Bellberry HREC approval expands HARNESS-1 trial sites
- Chris O’Brien Lifehouse and Austin Health to activate soon
- Trial tests RC220 with osimertinib in EGFR-mutant NSCLC
- Dose escalation and randomised expansion phases planned
- Additional sites pending governance approval
Bellberry Ethics Approval Enables Trial Expansion
Racura Oncology (ASX:RAC) has crossed a key regulatory milestone with the Bellberry Human Research Ethics Committee granting approval for its HARNESS-1 lung cancer clinical trial. This green light unlocks the activation of new Australian clinical sites beyond the lead Monash Health site, broadening the trial’s footprint and patient access.
The approval specifically covers private and eligible public hospitals outside Victoria, allowing prestigious centres like Chris O’Brien Lifehouse and Austin Health in Melbourne to progress towards governance and start-up phases. These sites bring considerable clinical expertise and patient volumes, crucial for the trial’s momentum.
HARNESS-1 Trial Design and Patient Focus
HARNESS-1 is a Phase 1a/b study evaluating Racura’s RC220 (E,E-bisantrene) combined with AstraZeneca’s osimertinib (Tagrisso®) in patients with non-small cell lung cancer (NSCLC) harbouring activating EGFR mutations. The trial uses circulating tumour DNA (ctDNA) screening to identify eligible patients, reflecting a precision oncology approach.
The initial dose-escalation phase will administer RC220 intravenously every 21 days alongside standard osimertinib, focusing on safety, tolerability, and pharmacokinetics. Between 12 and 40 patients are expected to participate in this stage. Following dose determination, a double-blind, randomised Phase 1b expansion will assess two dose levels in 40 patients, monitoring early clinical signals such as progression-free survival and ctDNA changes.
Strategic Implications for Racura’s Clinical Pipeline
With the recent Bellberry approval, Racura is positioned to accelerate enrolment and data collection, critical for advancing RC220’s clinical development. The company’s Principal Scientist, Dr Rodney Cusack, emphasised the importance of these additional sites for patient access and trial progress.
This development follows Racura’s recent successful capital raises totalling over $34 million, which fully fund ongoing trials including HARNESS-1, underpinning the company’s clinical ambitions. The expanded trial footprint could enhance recruitment speed and data robustness, vital for subsequent regulatory and commercial milestones.
While governance approvals remain pending for some sites, the trajectory suggests a growing network of Australian centres contributing to this precision medicine study. Investors will be watching how quickly these sites activate and enrol patients, as well as emerging safety and efficacy data.
Bottom Line?
Bellberry’s ethics approval unlocks new trial sites, potentially speeding patient enrolment and data generation for Racura’s lung cancer program.
Questions in the middle?
- How quickly will additional sites beyond Chris O’Brien Lifehouse and Austin Health activate and start enrolling patients?
- What early safety and pharmacokinetic signals will emerge from the dose-escalation phase of HARNESS-1?
- Could expanded patient access through multiple sites influence timelines for later-phase development or partnerships?