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

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.