This phase I, open-label, single-arm trial uses a "3+3" dose-escalation design to evaluate the safety, tolerability, and preliminary efffcacy of intranasal WSK-IM05 vaccine combined with tislelizumab as neoadjuvant therapy in patients with resectable HPV-positive oropharyngeal squamous cell carcinoma. Participants receive two cycles of WSK-IM05 (intranasal) and tislelizumab (200 mg IV) on day 1 of each 3-week cycle, followed by surgery. After surgery, patients receive standard of care (chemoradiotherapy or radiotherapy as indicated) plus 15 cycles of adjuvant tislelizumab. The main outcomes include dose-limiting toxicities and treatment-related adverse events.
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Incidence of Dose-Limiting Toxicities (DLTs)
Timeframe: First 21 days after first dose of WSK-IM05
Incidence and Severity of Treatment-Related Adverse Events (TRAEs)
Timeframe: From first dose through 30 days after last dose of WSK-IM05
Incidence of Serious Adverse Events (SAEs)
Timeframe: From first dose through 30 days after last dose