drugset / Trial / NCT05751512

A Study to Evaluate MRG003 vs Cetuximab/Methotrexate in in the Treatment of Patients With RM-SCCHN

NCT05751512

Phase 3 Unknown 180 enrolled Shanghai Miracogen Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of this study is to compare the efficacy and safety of MRG003 versus cetuximab/methotrexate as second/third line of therapy in patients with RM-SCCHN who have previously failed PD-1 (L1) inhibitors and platinum-based therapy.

Timeline

Start
2023-03
Primary completion
2025-08
Completion
2025-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Becotatug Vedotin Monoclonal antibody 2.3 mg/kg Intravenous
Comparator Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Comparator Methotrexate Small molecule 40 mg/m2 Intravenous