Clinical Trial: A Phase I Multicentre Randomized Double-Blind Parallel-Controlled Study of HLX05-N vs. ERBITUX(R) in Metastatic Colorectal Cancer

U.S., April 22 -- ClinicalTrials.gov registry received information related to the study (NCT07543471) titled 'A Phase I Multicentre Randomized Double-Blind Parallel-Controlled Study of HLX05-N vs. ERBITUX(R) in Metastatic Colorectal Cancer' on April 07.

Brief Summary: This is a multicentre, randomized, double-blind, parallel-controlled Phase 1 clinical study designed to evaluate the pharmacokinetic (PK) similarity, efficacy, safety, and immunogenicity of HLX05-N compared with US-sourced ERBITUX(R) and EU-sourced ERBITUX(R) in participants with metastatic colorectal cancer (mCRC) with wild-type KRAS/NRAS and no BRAF V600E mutation.

Approximately 387 participants will be randomized in a 1:1:1 ratio to receive HLX05-N, US-ERBITUX(R), or EU-E...