Ethics Approval Paves Way for Race Oncology’s Critical Lung Cancer Test
Race Oncology has received ethics approval to launch its HARNESS-1 Phase 1a/b trial testing RC220 combined with osimertinib in EGFR-mutated non-small cell lung cancer patients, marking a key step toward addressing resistance to current therapies.
- Human ethics approval granted by St Vincents Hospital Melbourne
- Phase 1a/b trial to evaluate RC220 with osimertinib in EGFR-mutated NSCLC
- Patient enrolment to begin late Q4 2025 or early Q1 2026 at Monash Health
- Trial uses Bayesian design to identify maximum tolerated dose of RC220
- Secondary endpoints include progression-free and overall survival
Ethics Approval Unlocks Clinical Trial
Race Oncology has achieved a significant regulatory milestone with the St Vincents Hospital Melbourne Human Research Ethics Committee granting approval for its HARNESS-1 Phase 1a/b clinical trial. This study will investigate the safety, tolerability, and pharmacokinetics of RC220, Race's proprietary formulation of E,E-bisantrene, in combination with AstraZeneca's osimertinib for patients suffering from non-small cell lung cancer (NSCLC) harbouring activating mutations in the epidermal growth factor receptor (EGFR).
Trial Design and Patient Enrollment
Patient recruitment is set to commence at Monash Health in Clayton, Victoria, pending final institutional approvals, with enrolment expected to begin in late Q4 2025 or early Q1 2026. The multi-centre trial will initially screen patients using circulating tumour DNA (ctDNA) to identify eligible candidates receiving osimertinib. Phase 1a employs a Bayesian dose-escalation design, starting with small cohorts to determine the maximum tolerated dose (MTD) of RC220 when combined with standard care.
The trial anticipates enrolling between 12 and 40 patients in Phase 1a, reflecting the adaptive nature of the study design which allows flexibility to home in on the optimal dosing. Following dose determination, the Phase 1b stage will expand to 40 patients randomized across two dose levels, with a focus on safety, pharmacokinetics, and exploratory efficacy endpoints such as progression-free survival and overall survival.
Addressing Resistance in EGFR-Mutated NSCLC
Resistance to third-generation EGFR tyrosine kinase inhibitors like osimertinib remains a critical challenge in treating NSCLC. Race Oncology’s RC220, acting as a G-quadruplex binder, targets pathways implicated in this resistance, potentially offering a novel therapeutic avenue. Principal Scientist Dr Rodney Cusack highlighted the promise of this mechanism to impact patient outcomes significantly.
CEO Dr Daniel Tillett emphasized the importance of this ethics approval as a major step forward for Race, underscoring the company’s commitment to addressing unmet medical needs in lung cancer. The collaboration with Beyond Drug Development and multiple clinical sites aims to accelerate patient access and data generation.
Looking Ahead
With the trial poised to begin enrolment soon, Race Oncology is positioning itself at the forefront of innovative lung cancer therapies. The outcomes of HARNESS-1 will be closely watched by investors and clinicians alike, as they could pave the way for further development and potential regulatory approvals. The company’s broader pipeline, including Phase 3 programs in other oncology indications, adds to the strategic significance of this milestone.
Bottom Line?
Race Oncology’s ethics approval sets the stage for a critical test of RC220’s potential to overcome lung cancer drug resistance.
Questions in the middle?
- How quickly will patient enrolment progress across multiple sites?
- What safety and efficacy signals will emerge from the Phase 1a dose escalation?
- Could positive trial results accelerate partnerships or commercial interest?
