drugset / Trial / NCT07524452

Becotatug Vedotin (MRG003) in Combination With PD-1 Inhibitor Versus PD-1 Inhibitor for the Treatment of EGFR-positive, CPS≥1 Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma

NCT07524452

Phase 3 Recruiting 430 enrolled Ming-Yuan Chen
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a randomized, open-label, multicenter phase III trial designed to systematically evaluate the efficacy and safety of perioperative neoadjuvant and adjuvant therapy with Becotatug vedotin in combination with PD-1 inhibitor versus PD-1 inhibitor alone in patients with EGFR-positive, CPS ≥ 1 resectable locally advanced head and neck squamous cell carcinoma .

Timeline

Start
2026-02-06
Primary completion
2031-02-28
Completion
2032-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Becotatug Vedotin Monoclonal antibody
Subject Pucotenlimab Monoclonal antibody 200 mg
Background Cisplatin Other / unclassified 100 mg/m2 Intravenous