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RECRUITING
NCT07565740
PHASE1

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

Sponsor: West China Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2026-05-15

Completion Date

2028-05-10

Last Updated

2026-09-22

Healthy Volunteers

No

Interventions

BIOLOGICAL

WSK-IM05 (4×10^10 vp)

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.

BIOLOGICAL

WSK-IM05 (8×10^10 vp)

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.

BIOLOGICAL

WSK-IM05 (1.6x10^11 vp)

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.

DRUG

Tislelizumab

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)

West China Hospital, Sichuan University

Chengdu, Sichuan, China