A multicenter, randomized, double-blind, phase II clinical study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of Becotatug Vedotin for Injection in combination with PD-1 in patients with locally advanced resectable head and neck squamous cell carcinoma
Life expectancy ≥ 6 months.
Subjects with histologically confirmed, resectable Stage III-IVA head and neck squamous cell carcinoma (HNSCC) eligible for curative-intent surgery.
At least one extracranial measurable lesion per RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Primary tumor originating from nasopharynx, nasal cavity, paranasal sinuses, salivary gland, thyroid/parathyroid gland, skin, or unknown primary site (squamous cell carcinoma).
Head and neck cancer deemed non-resectable by the investigator.
Prior treatment with anti-PD-1, anti-PD-L1, MMAE/MMAF-based ADC agents, or other T-cell immune checkpoint inhibitors.
Prior radiotherapy, systemic anti-tumor therapy, or other investigational therapy for head and neck cancer before study entry.