drugset / Trial / NCT07381075

A Phase II Clinical Trial of Anti-EGFR Antibody-drug Conjugate (ADC) Combined With or Without Immune Checkpoint Inhibitors in the Neoadjuvant Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma

NCT07381075

Phase 2 Not yet recruiting 120 enrolled West China Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

A Randomized, Non-comparative, Multicenter Phase II Clinical Trial of Becotatug Vedotin Combined with or without Immune Checkpoint Inhibitors (Penpulimab/Ivonescimab) in the Neoadjuvant Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (LAHNSCC). This proposed study will evaluate the efficacy and safety of preoperative administration of Becotatug Vedotin Combined with or without Immune Checkpoint Inhibitors (Penpulimab/Ivonescimab) in LAHNSCC who are eligible for resection.

Timeline

Start
2026-02-01
Primary completion
2028-10-01
Completion
2029-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Becotatug Vedotin Monoclonal antibody 2.3 mg/kg Intravenous
Subject Ivonescimab Monoclonal antibody 10 mg/kg Intravenous
Subject Penpulimab Monoclonal antibody 200 mg Intravenous