Phase 1 Study of HLX05-N vs ERBITUX in Metastatic Colorectal Cancer
Summary
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.
What changed
NIH registered a new Phase 1 clinical trial on ClinicalTrials.gov comparing HLX05-N biosimilar candidate against reference ERBITUX (cetuximab) in metastatic colorectal cancer participants with wild-type RAS and no BRAF V600E mutation. The trial uses a three-arm design with approximately 387 participants randomized equally to HLX05-N, US-ERBITUX, or EU-ERBITUX, all combined with mFOLFOX6 chemotherapy.
This registry entry is informational only and does not impose compliance obligations. Pharmaceutical companies conducting similar biosimilar development programs may monitor this trial for competitive intelligence, while institutional review boards and clinical investigators at participating sites should ensure proper trial registration and reporting obligations under applicable regulations are met.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Phase I Multicentre Randomized Double-Blind Parallel-Controlled Study of HLX05-N vs. ERBITUX® in Metastatic Colorectal Cancer
Phase 1 NCT07543471 Kind: PHASE1 Apr 21, 2026
Abstract
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® and EU-sourced ERBITUX® 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®, or EU-ERBITUX®. Randomization will be stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1) and sex (male vs. female).
During the treatment period, participants will receive study treatment in combination with mFOLFOX6 chemotherapy. For the first 3 treatment cycles, participants will receive HLX05-N or US-/EU-ERBITUX® plus chemotherapy according to randomized assignment. After completion of the initial 3 cycles, participants originally assigned to the US-ERBITUX® or EU-ERBITUX® arms will switch, in a blinded manner, to HLX05-N 250 mg/m² administered in combination with chemotherapy on Day 1 of each cycle. Study treatment will continue until investigator-assessed disease progression, death, initiation of new anti-tumor therapy, unacceptable toxicity, withdrawal of informed consent, study termination, or 1 year after randomization, whichever occurs first.
For participants with disease response or stable disease after 12 cycles of treatment, oxaliplatin may be discontinued, and mainten...
Conditions: mCRC
Interventions: Cetuximab, mFOLFOX6
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