drugset / Trial / NCT07829588
Pharmacokinetic (PK) Study of QL1203 and Vectibix® for the Treatment of RAS Wild-type Metastatic Colorectal Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Panitumumab | Monoclonal antibody | 6 mg/kg | — |
| Subject | QL1203 | Monoclonal antibody | 6 mg/kg | — |