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 .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
136
QL1203 (6mg/kg) combined with mFOLFOX6, Q2W
Vectibix® (6mg/kg) combined with mFOLFOX6, Q2W
AUCtau, sd
Area under the serum concentration-time curve over one dosing interval after the first dose of QL1203 and Vectibix®
Time frame: through the Cycle 1 (each cycle is 2 weeks)
AUCtau,ss,
Area under the serum concentration-time curve over one dosing interval at steady state (at Cycle 4)
Time frame: through the Cycle 4 (each cycle is 2 weeks)
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