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NOT YET RECRUITING
NCT07829588
PHASE1

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

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

DRUG

QL1203 + mFOLFOX6

QL1203 (6mg/kg) combined with mFOLFOX6, Q2W

DRUG

Vectibix®+ mFOLFOX6

Vectibix® (6mg/kg) combined with mFOLFOX6, Q2W