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 maintenance therapy with cetuximab in combination with leucovorin and 5-fluorouracil may continue. Participants who continue to benefit from treatment after 1 year following randomization may receive subsequent therapy according to local clinical practice.
PK and anti-drug antibody (ADA) samples will be collected from all participants to assess PK characteristics and immunogenicity. An end-of-treatment visit will be performed within 7 days after treatment discontinuation. Safety follow-up will be conducted 30 days after the last dose, with an additional telephone safety follow-up at 12 weeks after the last dose. Survival follow-up will continue for up to 1 year after randomization.
1. Participants must have signed and dated an IRB/IEC approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines, and is willing to comply with all study procedures and rules required by the protocol.
1. History of illicit drug use or alcohol abuse in the investigator's judgment within 12 months prior to screening.
Parallel
Cetuximab
Drug400 mg/m2 administered as about 120-minute intravenous infusion on the first day of treatment. If the first infusion is well tolerated, then 250 mg/m2 intravenous infusion in about 1 hour weekly
mFOLFOX6
DrugOxaliplatin, Leucovorin, 5-FU
• Area under the serum concentration-time curve from time 0 to 7 days (AUC0-7d) after the 1st dose
Area under the serum concentration-time curve within a dosing interval at steady state (AUCss) after the 3rd dose
maximum serum drug concentration (Cmax)
Objective response rate (ORR) assessed by the Investigators (based on RECIST v1.1)
Time to response (TTR) assessed by the Investigators (based on RECIST v1.1)
Adverse Events (AEs)
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