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
Inclusion Criteria1
- \. Age ≥ 18 years, male or female.2. Histologically confirmed oropharyngeal squamous cell carcinoma meeting all of the following criteria: Newly diagnosed, HPV-positive, without distant metastases; Confirmed p16 positive by immunohistochemistry (defined as ≥70% moderate to strong nuclear and cytoplasmic staining of tumor cells)；Assessed by head and neck surgery as resectable; Willing to undergo surgical treatment.3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.4. Adequate organ and bone marrow function, defined as:Hematology: neutrophil count (NEUT) ≥ 1.5×10⁹/L; platelet count (PLT) ≥ 80×10⁹/L; hemoglobin ≥ 8 g/dL; Liver function: AST, ALT, ALP ≤ 2.5×upper limit of normal (ULN); total bilirubin (TBIL) ≤ 1.5×ULN; Albumin ≥ 2.8 g/dL.Renal function: serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance (CCr) > 60 mL/min; Coagulation: international normalized ratio (INR) ≤ 1.5; activated partial thromboplastin time (APTT) ≤ 1.5×ULN; Adenovirus type 5(Ad5) neutralizing antibody titer ≤ 1:200.5. Willing to voluntarily sign the informed consent form and able to comply with protocol-required visits and procedures.
Interested in this trial?
Get notified about updates and connect with the research team.
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