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Pharmacokinetic (PK) Study of QL1203 and Vectibix® for the Treatment of RAS Wild-type Metastatic Colorectal Cancer
Sponsor: Qilu Pharmaceutical Co., Ltd.
Summary
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 .
Official title: A Randomized, Double-Blind, Parallel-Controlled, Multicenter Phase I Study to Evaluate the Pharmacokinetic Similarity Between QL1203 (Vectibix® Biosimilar Candidate) and Panitumumab (EU-Vectibix®) in Combination With mFOLFOX6 Respectively in Patients With RAS Wild-Type Metastatic Colorectal Cancer
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
136
Start Date
2026-11-24
Completion Date
2028-08-30
Last Updated
2026-09-21
Healthy Volunteers
No
Interventions
QL1203 + mFOLFOX6
QL1203 (6mg/kg) combined with mFOLFOX6, Q2W
Vectibix®+ mFOLFOX6
Vectibix® (6mg/kg) combined with mFOLFOX6, Q2W