drugset / Trial / NCT07829588

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

NCT07829588 ↗

Phase 1 Not yet recruiting 136 enrolled Qilu Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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 .

Timeline

Start
2026-11-24
Primary completion
2028-02-28
Completion
2028-08-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Panitumumab Monoclonal antibody 6 mg/kg —
Subject QL1203 Monoclonal antibody 6 mg/kg —

Indications