Intranasal WSK-IM05 Vaccine Plus Tislelizumab as Neoadjuvant Therapy for HPV+ OPSCC

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.

NCT Number	NCT07565740
Lead Sponsor	West China Hospital
Conditions	HPV-positive Oropharyngeal Squamous Cell Carcinoma
Enrollment	9 participants
Start Date	2026-05-10
Primary Completion	2027-05-10 (estimated)
Study Completion	2028-05-10 (estimated)
Updated on ClinicalTrials.gov	2026-05-11