Intranasal WSK-IM05 Vaccine Plus Tislelizumab as Neoadjuvant Therapy for HPV+ OPSCC
A Prospective, Single-Arm Clinical Study of Intranasal Recombinant Adenovirus Vaccine WSK-IM05 Combined With Tislelizumab as Neoadjuvant Therapy for HPV-Positive Oropharyngeal Squamous Cell Carcinoma
West China Hospital
9 participants
May 10, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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Interventions
Intranasal recombinant adenovirus vaccine WSK-IM05 at a dose of 4×10\^10 vp administered via nasal spray on day 1 of each 3-week cycle for 2 cycles.
Intranasal recombinant adenovirus vaccine WSK-IM05 at a dose of 8×10\^10 vp administered via nasal spray on day 1 of each 3-week cycle for 2 cycles.
Intranasal recombinant adenovirus vaccine WSK-IM05 at a dose of 1.6x10\^11 vp administered via nasal spray on day 1 of each 3-week cycle for 2 cycles.
Tislelizumab at a dose of 200 mg administered intravenously on day 1 of each 3-week cycle for 2 cycles (neoadjuvant phase), followed by 200 mg intravenously every 3 weeks for 15 cycles (adjuvant phase after surgery).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07565740