drugset
drugset / Trial / NCT07524413

Becotatug Vedotin (MRG003) With PD-1 Blockade and Chemoradiotherapy in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma

NCT07524413 ↗

Phase 3 Not yet recruiting 514 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized controlled trial aims to evaluate the efficacy and safety of Becotatug Vedotin (MRG003), an antibody-drug conjugate (ADC), combined with the PD-1 inhibitor Pucotenlimab as induction therapy for high-risk locoregionally advanced nasopharyngeal carcinoma (NPC), compared to the standard gemcitabine and cisplatin (GP) regimen combined with Pucotenlimab, followed by concurrent chemoradiotherapy (CCRT) and adjuvant immunotherapy.

Timeline

Start
2026-04
Primary completion
2030-04
Completion
2032-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Becotatug Vedotin Monoclonal antibody 2 mg/kg Intravenous
Subject Cisplatin Other / unclassified 80 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 100 mg/m2 Intravenous
Comparator Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Pucotenlimab Monoclonal antibody 200 mg Intravenous

Indications

nasopharyngeal carcinoma