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Phase 1 Study of HLX05-N vs ERBITUX in Metastatic Colorectal Cancer

NIH registered a Phase 1 multicentre, randomized, double-blind, parallel-controlled clinical trial (NCT07543471) comparing HLX05-N with US-sourced and EU-sourced ERBITUX in participants with metastatic colorectal cancer. Approximately 387 participants will be randomized in a 1:1:1 ratio and treated with study drug in combination with mFOLFOX6 chemotherapy. The study evaluates pharmacokinetic similarity, efficacy, safety, and immunogenicity across the three arms.