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Highlights
- Human ethics approval granted for HARNESS-1 trial
- Multi-centre study to begin patient enrolment
- Study explores RC220 with standard-of-care therapy
Race Oncology Ltd (ASX:RAC) has achieved a significant milestone by securing human ethics approval to initiate its HARNESS-1 Phase 1a/b lung cancer trial of RC220 in combination with osimertinib. The St Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC) has reviewed and cleared the trial, paving the way for a comprehensive study of RC220 (E,E-bisantrene, RCDS1) alongside osimertinib (Tagrisso®; AstraZeneca) in adult patients with non-small cell lung cancer (NSCLC) carrying activating epidermal growth factor receptor mutations (EGFRm).
The HARNESS-1 trial aims to investigate the safety, tolerability, and pharmacokinetics of RC220 in combination with osimertinib, addressing a critical gap for patients who develop resistance to existing third-generation EGFRm NSCLC therapies. The study is set to be a multi-centre effort, with the lead site at Monash Health in Clayton, Victoria, ready to begin enrolling patients following final institutional approval and site activation. Additional sites are expected to be activated in the coming months, expanding the reach of the study.
The Phase 1a/b study will employ circulating tumour DNA (ctDNA) to screen and enrol patients who are already receiving standard-of-care osimertinib. The initial Phase 1a stage includes ctDNA screening followed by dose escalation of RC220. Patients will receive intravenous RC220 on a 21-day cycle alongside their ongoing osimertinib treatment. This phase uses a Bayesian dose-escalation model, starting with smaller patient cohorts and gradually expanding to determine the maximum tolerated dose (MTD) of RC220.
Patients will remain on the combination therapy until achieving disease control, completing a year of treatment, experiencing disease progression, or encountering unacceptable toxicity or withdrawal. Once the MTD is identified, accumulated safety and pharmacokinetic data will guide the transition into the double-blind, randomised Phase 1b dose-expansion stage. This phase will involve patient randomisation to different RC220 dose levels, assessing a range of secondary and exploratory outcomes including progression-free survival, overall survival, ctDNA changes, and alterations in cancer-specific mutations.
HARNESS-1 represents a notable step for Race Oncology (ASX:RAC) in developing targeted lung cancer therapies. The trial’s design incorporates robust monitoring and data collection to ensure comprehensive safety and efficacy evaluation, while also offering insights into disease progression mechanisms and potential pathways for personalised treatment approaches.
The study is expected to offer important insights into how RC220 interacts with standard-of-care therapy, enhancing understanding of combination treatment strategies for NSCLC. This effort aligns with broader developments in the ASX stock market where biotechnology advancements continue to intersect with healthcare innovation. Investors and stakeholders tracking the ASX100 and ASX300 indices may find the progression of clinical trials like HARNESS-1 an important factor in shaping healthcare sector dynamics.
Additionally, the trial reflects the growing focus on personalised medicine approaches, leveraging biomarkers such as ctDNA to optimise patient enrolment and treatment strategies. This targeted approach mirrors trends observed in broader investment areas, including ASX mining stocks and ASX dividend stocks, where precise and data-driven strategies are increasingly valued.
Race Oncology’s multi-centre strategy, combined with rigorous clinical monitoring, ensures that findings from the HARNESS-1 trial will contribute meaningfully to the scientific community, potentially informing future NSCLC treatment paradigms. As sites begin enrolment, the study is poised to gather critical data on the tolerability and therapeutic potential of RC220, helping to chart the course for subsequent clinical development phases.
The research also emphasises the importance of collaboration across healthcare institutions and clinical trial management organisations, highlighting the integrated efforts necessary to advance oncology therapies. By combining expertise from multiple research sites and centralising oversight through lead investigators, HARNESS-1 ensures a structured and well-monitored approach to patient care and data collection.
As clinical trials progress globally, studies like HARNESS-1 serve as benchmarks for incorporating advanced diagnostic tools, personalised treatment protocols, and collaborative trial designs into modern oncology research. The trial’s findings could influence treatment approaches not only for patients with EGFRm NSCLC but also for broader cancer research, showcasing innovative trial methodologies.
