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Race Oncology Gains Ethics Approval for HARNESS-1 Phase 1a/b RC220 Lung Cancer Trial.

Race Oncology Limited (ASX: RAC) has secured human ethics approval to commence its HARNESS-1 Phase 1a/b clinical trial assessing RC220 in combination with osimertinib for patients with EGFR-mutated non-small cell lung cancer. Approval from the St Vincents Hospital Melbourne HREC enables Monash Health to begin enrolling patients once final site activation steps are completed, anticipated between late Q4 2025 and early Q1 2026. The multi-centre trial will use ctDNA to identify suitable candidates and will initially focus on dose escalation to establish the maximum tolerated dose of RC220.

After completing Phase 1a, the study will progress to a randomised Phase 1b dose-expansion stage involving 40 participants. This phase will evaluate safety, pharmacokinetics and clinical outcomes such as progression-free survival, overall survival and ctDNA response. With multiple sites preparing for activation, this approval marks a key milestone for Race Oncology as it advances RC220 to address emerging resistance pathways in EGFR-mutated lung cancer.

 

 

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