Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07565740

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

Led by West China Hospital · Updated on 2026-05-11

9

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, male or female
  • Newly diagnosed HPV-positive oropharyngeal squamous cell carcinoma confirmed by p16 immunohistochemistry (≥70% tumor cell staining)
  • No distant metastases and cancer assessed as resectable by head and neck surgery
  • Willing to undergo surgical treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ and bone marrow function including neutrophil count ≥1.5x10^9/L, platelet count ≥80x10^9/L, hemoglobin ≥8 g/dL
  • Liver function: AST, ALT, ALP ≤2.5 times upper normal limit; total bilirubin ≤1.5 times upper normal limit; albumin ≥2.8 g/dL
  • Renal function: serum creatinine ≤1.5 times upper normal limit or creatinine clearance >60 mL/min
  • Coagulation: INR ≤1.5; activated partial thromboplastin time ≤1.5 times upper normal limit
  • Adenovirus type 5 neutralizing antibody titer ≤1:200
  • Willing and able to comply with informed consent and protocol procedures
Not Eligible

You will not qualify if you...

  • History of other cancers except certain treated skin, bladder, cervical, or gastrointestinal cancers without recurrence within 5 years
  • Active or history of autoimmune diseases including neurological and systemic autoimmune disorders
  • Severe allergies or known allergy to study vaccine components or PD-1 antibody
  • Prior treatment with PD-1, PD-L1, PD-L2, CTLA-4 antibodies, EGFR-targeted therapies, or antitumor vaccines
  • Use of active infectious disease vaccines within 4 weeks before first dose or planned during study
  • Major surgery or severe trauma within 4 weeks before first dose
  • Unresolved prior treatment toxicities above specified severity
  • Severe medical conditions such as significant cardiac dysfunction, poorly controlled diabetes or hypertension, low heart ejection fraction, or risky ECG abnormalities
  • History or suspicion of interstitial lung disease or active/uncontrolled tuberculosis
  • Hyperthyroidism or untreated thyroid disease
  • Active infection, recent fever, or recent systemic antibiotic use
  • Active hepatitis B or C, known HIV infection or AIDS
  • History of neurological or psychiatric disorders like epilepsy or dementia
  • Drug or alcohol abuse within 3 months
  • Pregnancy, breastfeeding, or plans to conceive within 3 months after study
  • Recent investigational drug use or concurrent enrollment in interventional studies
  • Other conditions that could interfere with study participation or completion

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

West China Hospital, Sichuan University

Chengdu, Sichuan, China, 610000

Actively Recruiting

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Research Team

X

Xingchen Peng

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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