Pharmacokinetic (PK) Study of QL1203 and Vectibix® for the Treatment of RAS Wild-type Metastatic Colorectal Cancer

This is a randomized, double-blind, parallel-controlled, multicenter clinical trial to evaluate the pharmacokinetic similarity between QL1203 and Vectibix® in patients with RAS wild-type metastatic colorectal cancer. Eligible trial participants will be randomized in a 1:1 ratio to either the QL1203 or Vectibix® groups, to received QL1203 + mFOLFOX6 and the control group received Vectibix® + mFOLFOX6. PK profiles, immunogenicity, safety and preliminary efficacy will be evaluated and compared between two groups .

Inclusion Criteria: * Voluntarily participate, have read, understood and signed the informed consent form (ICF), and are able to follow the study procedures. * Male or female aged ≥18 years. * Metastatic colorectal adenocarcinoma confirmed by histology or cytology, and not suitable for radical surgery, radiotherapy, radiofrequency ablation and other local treatments. * Wild-type RAS and wild-type BRAF. * At least 1 definite measurable tumor lesion according to RECIST v1.1. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 0-1. * Have adequate organ function. Exclusion Criteria: * Previous systemic treatment: The time from the last dose of neoadjuvant or adjuvant therapy to disease recurrence is \> 6 months. * Previous treatment with epidermal growth factor receptor (EGFR) targeted drugs for colorectal cancer. * Trial participants known to have high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). * Presence of active central nervous system metastases. * Participants with a history of malignancies other than colorectal cancer within 5 years prior to the first dose. * Trial participants (both male and female) who are unwilling to accept effective contraception; female trial participants who are pregnant or breastfeeding.