AzTrials
AzTrials

HPV-positive Oropharyngeal Squamous Cell CarcinomaPhase 1NCT07565740

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

A Phase 1 study testing WSK-IM05 (4×10^10 vp), WSK-IM05 (8×10^10 vp) and WSK-IM05 (1.6x10^11 vp) in people with HPV-positive Oropharyngeal Squamous Cell Carcinoma, run by West China Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
WSK-IM05 (4×10^10 vp), WSK-IM05 (8×10^10 vp) and WSK-IM05 (1.6x10^11 vp)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChina
Study dates
15 May 2026to 10 May 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. 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.

Who cannot join

  • 1. History of other malignancies (except for adequately treated and with no recurrence within 5 years:basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer,cervical carcinoma in situ, intramucosal gastrointestinal carcinoma, or other malignancies deemed eligible by the investigator).2. Any active autoimmune disease or history of autoimmune disease,including but not limited to immune-related neurological disorders, multiple sclerosis, autoimmune(demyelinating) neuropathy, Guillain-Barré syndrome, myasthenia gravis, systemic lupus erythematosus(SLE), connective tissue disease, scleroderma, inflammatory bowel disease (including Crohn's disease and ulcerative colitis), autoimmune hepatitis, toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome (excluding type I diabetes mellitus managed with stable insulin doses).3. History of allergic disease, severe drug allergy, or known allergy to any component of large molecule protein preparations,PD-1 monoclonal antibody injections, or the intranasal recombinant adenovirus vaccine (note: severe allergy is defined as requiring hospitalization).4. Prior receipt of any of the following treatments:a. Prior use of PD-1 antibody, PD-L1 antibody, PD-L2 antibody, CTLA-4 antibody, EGFR antibody, or EGFR-TKI.b. Prior receipt of an antitumor vaccine.c. Use of any active vaccine against infectious diseases (e.g.,inffuenza vaccine, varicella vaccine) within 4 weeks before first dose or planned during the study period.d. Major surgery or severe trauma within 4 weeks before first dose.e. Prior antitumor toxicity not recovered to ≤ CTCAE v5.0 grade 1 (excluding alopecia or sequelae of prior platinum-related neuropathy) or to the levels specified in inclusion/exclusion criteria.5. Presence of severe medical conditions, such as: Cardiac dysfunction grade II or higher (NYHA criteria), ischemic heart disease (e.g., myocardial infarction or angina), clinically significant supraventricular or ventricular arrhythmias; Poorly controlled diabetes (fasting blood glucose ≥ 10 mmol/L); Poorly controlled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg); Echocardiography showing ejection fraction < 50%; QTc interval: > 450 msec in males, > 470 msec in females; Any ECG abnormality that, in the investigator's opinion, poses additional risk for the study drug.6. History of interstitial lung disease, non-infectious pneumonitis, or high suspicion of interstitial lung disease; or conditions that might interfere with detection or management of suspected drug-related pulmonary toxicity. Patients with a prior history of drug-induced or radiation-induced non-infectious pneumonitis who are asymptomatic may be enrolled. Active tuberculosis or past tuberculosis that remains uncontrolled after treatment.7. Patients with hyperthyroidism or organic thyroid disease. Hypothyroidism managed with a stable dose of thyroid replacement hormone may be enrolled (as conffrmed by the investigator and/or endocrinologist).8. Active infection, or unexplained fever within 48 hours before first dose, or use of systemic antibiotics within 1 week before signing informed consent.9. Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL) or active hepatitis C (positive HCV antibody with HCV RNA above the lower limit of detection), or known positive HIV test or known acquired immunodeffciency syndrome (AIDS).10. Clear history of neurological or psychiatric disorders, such as epilepsy or dementia.11. Clear history of drug abuse or alcohol abuse within 3 months.12. Pregnant or breast feeding women; participants (and their partners) who plan to conceive within 3 months after the study period, have unprotected sexual intercourse, or are unwilling to use adequate contraceptive measures (e.g., condom,intrauterine device, or partner sterilization).13. Receipt of any investigational drug within 4 weeks before first dose, or concurrent enrollment in another clinical study, unless it is an observational (non-interventional) study or the follow-up phase of an interventional study.14. Any other condition that,in the investigator's judgment, might interfere with the study, including inability to complete study treatment and follow-up.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xingchen Peng contact

18980606753

pxx2014@163.com

China1 site, 1 recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610000

    Sichuan University West China Hospital, +8602885421141, pxx2014@163.com

    Recruiting

Other trials in China

About this study

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

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.

Being tested
WSK-IM05 (4×10^10 vp), WSK-IM05 (8×10^10 vp), WSK-IM05 (1.6x10^11 vp), Tislelizumab
Keywords
HPV-positive oropharyngeal squamous cell carcinoma, Neoadjuvant therapy, PD-1 inhibitor, Pathological response

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WSK-IM05 (4×10^10 vp)Biological

    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.

  • WSK-IM05 (8×10^10 vp)Biological

    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.

  • WSK-IM05 (1.6x10^11 vp)Biological

    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.

  • TislelizumabDrug

    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).

Study groups in NCT07565740
Study groupRoleWhat they receive
WSK-IM05 (4×10^10 vp) + TislelizumabExperimentalParticipants receive two cycles (each cycle = 3 weeks) of neoadjuvant treatment. On day 1 of each cycle: intranasal WSK-IM05 vaccine at a dose of 4×10^10 vp and tislelizumab 200 mg intravenously. After two cycles, patients undergo radical surgery followed by standard postoperative therapy plus 15 cycles of adjuvant tislelizumab (200 mg every 3 weeks). Dose-limiting toxicity (DLT) is assessed during the first 21 days after the first dose.
Receives: Biological: WSK-IM05 (4×10^10 vp); Drug: Tislelizumab
Arm 2: WSK-IM05 (8×10^10 vp) + TislelizumabExperimentalParticipants receive two cycles (each cycle = 3 weeks) of neoadjuvant treatment. On day 1 of each cycle: intranasal WSK-IM05 vaccine at a dose of 8×10^10 vp and tislelizumab 200 mg intravenously. After two cycles, patients undergo radical surgery followed by standard postoperative therapy plus 15 cycles of adjuvant tislelizumab (200 mg every 3 weeks). Dose-limiting toxicity (DLT) is assessed during the first 21 days after the first dose.
Receives: Biological: WSK-IM05 (8×10^10 vp); Drug: Tislelizumab
Arm 3: WSK-IM05(1.6×10^11 vp) + TislelizumabExperimentalParticipants receive two cycles (each cycle = 3 weeks) of neoadjuvant treatment. On day 1 of each cycle: intranasal WSK-IM05 vaccine at a dose of 1.6×10^11 vp and tislelizumab 200 mg intravenously. After two cycles, patients undergo radical surgery followed by standard postoperative therapy plus 15 cycles of adjuvant tislelizumab (200 mg every 3 weeks). Dose-limiting toxicity (DLT) is assessed during the first 21 days after the first dose.
Receives: Biological: WSK-IM05 (1.6x10^11 vp); Drug: Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Dose-Limiting Toxicities (DLTs)

    Proportion of participants experiencing DLTs within the DLT observation period (first 21 days after the first dose), as defined per protocol.

    Measured: First 21 days after first dose of WSK-IM05 (approximately 21 days in total)

  2. Incidence and Severity of Treatment-Related Adverse Events (TRAEs)

    Type, incidence, severity (grade 1-5 according to CTCAE v5.0), and causality assessment of all treatment-related adverse events.

    Measured: From first dose through 30 days after last dose of WSK-IM05 (approximately 2 months in total)

  3. Incidence of Serious Adverse Events (SAEs)

    Including immune-related adverse events (irAEs), injection/administration site reactions, allergic reactions, etc.

    Measured: From first dose through 30 days after last dose (approximately 2 months in total)

Secondary outcomes (5)

  1. Major Pathological Response (MPR)

    Proportion of participants who undergo surgery with residual viable tumor ≤10% (%RVT ≤10%) in the tumor bed according to irPRC criteria, regardless of lymph node status.

    Measured: At time of surgery (approx. Week 6-10)

  2. Pathological Complete Response (pCR)

    Proportion of participants who undergo surgery with no residual viable tumor cells (%RVT = 0) in the tumor bed and resected lymph nodes according to irPRC criteria.

    Measured: At time of surgery (approx. Week 6-10)

  3. Objective Response Rate (ORR)

    Proportion of participants achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.

    Measured: After 2 cycles of neoadjuvant therapy (prior to surgery, approx. Week 5-9)

  4. Event-Free Survival (EFS)

    Time from first dose to first occurrence of any of the following: disease progression during neoadjuvant therapy leading tolerability to undergo radical surgery; local, regional, or distant tumor recurrence after surgery; or death from any cause.

    Measured: From first dose up to approximately 3 years

  5. Overall Survival (OS）

    Overall Survival (OS) is defined as the time from the first dose of study treatment to death from any cause. For subjects who have not experienced this event by the time of the last follow-up, data will be censored at the date of the last tumor assessment or the date of the last follow-up.

    Measured: From the first dose of study treatment until death from any cause

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2026
  2. Study start15 May 2026
  3. Primary completion10 May 2027 (estimated)
  4. Study completion10 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07565740
Sponsor's protocol ID
2026-891
Status last verified
Sep 2026
First submitted
27 Apr 2026
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chaturvedi AK, Engels EA, Pfeiffer RM, Hernandez BY, Xiao W, Kim E, Jiang B, Goodman MT, Sibug-Saber M, Cozen W, Liu L, Lynch CF, Wentzensen N, Jordan RC, Altekruse S, Anderson WF, Rosenberg PS, Gillison ML. Human papillomavirus and rising oropharyngeal cancer incidence in the United States. J Clin Oncol. 2011 Nov 10;29(32):4294-301. doi: 10.1200/JCO.2011.36.4596. Epub 2011 Oct 3.

    PubMed 21969503

  • Gillison ML, Chaturvedi AK, Anderson WF, Fakhry C. Epidemiology of Human Papillomavirus-Positive Head and Neck Squamous Cell Carcinoma. J Clin Oncol. 2015 Oct 10;33(29):3235-42. doi: 10.1200/JCO.2015.61.6995. Epub 2015 Sep 8.

    PubMed 26351338

  • Senkomago V, Henley SJ, Thomas CC, Mix JM, Markowitz LE, Saraiya M. Human Papillomavirus-Attributable Cancers - United States, 2012-2016. MMWR Morb Mortal Wkly Rep. 2019 Aug 23;68(33):724-728. doi: 10.15585/mmwr.mm6833a3.

    PubMed 31437140

  • Schache AG, Powell NG, Cuschieri KS, Robinson M, Leary S, Mehanna H, Rapozo D, Long A, Cubie H, Junor E, Monaghan H, Harrington KJ, Nutting CM, Schick U, Lau AS, Upile N, Sheard J, Brougham K, West CM, Oguejiofor K, Thomas S, Ness AR, Pring M, Thomas GJ, King EV, McCance DJ, James JA, Moran M, Sloan P, Shaw RJ, Evans M, Jones TM. HPV-Related Oropharynx Cancer in the United Kingdom: An Evolution in the Understanding of Disease Etiology. Cancer Res. 2016 Nov 15;76(22):6598-6606. doi: 10.1158/0008-5472.CAN-16-0633. Epub 2016 Aug 28.

    PubMed 27569214

  • Craig SG, Anderson LA, Schache AG, Moran M, Graham L, Currie K, Rooney K, Robinson M, Upile NS, Brooker R, Mesri M, Bingham V, McQuaid S, Jones T, McCance DJ, Salto-Tellez M, McDade SS, James JA. Recommendations for determining HPV status in patients with oropharyngeal cancers under TNM8 guidelines: a two-tier approach. Br J Cancer. 2019 Apr;120(8):827-833. doi: 10.1038/s41416-019-0414-9. Epub 2019 Mar 20.

    PubMed 30890775

  • Lechner M, Liu J, Masterson L, Fenton TR. HPV-associated oropharyngeal cancer: epidemiology, molecular biology and clinical management. Nat Rev Clin Oncol. 2022 May;19(5):306-327. doi: 10.1038/s41571-022-00603-7. Epub 2022 Feb 1.

    PubMed 35105976

  • Uppaluri R, Haddad RI, Tao Y, Le Tourneau C, Lee NY, Westra W, Chernock R, Tahara M, Harrington KJ, Klochikhin AL, Brana I, Vasconcelos Alves G, Hughes BGM, Oliva M, Pinto Figueiredo Lima I, Ueda T, Rutkowski T, Schroeder U, Mauz PS, Fuereder T, Laban S, Oridate N, Popovtzer A, Mach N, Korobko Y, Costa DA, Hooda-Nehra A, Rodriguez CP, Bell RB, Manschot C, Benjamin K, Gumuscu B, Adkins D; KEYNOTE-689 Investigators. Neoadjuvant and Adjuvant Pembrolizumab in Locally Advanced Head and Neck Cancer. N Engl J Med. 2025 Jul 3;393(1):37-50. doi: 10.1056/NEJMoa2415434. Epub 2025 Jun 18.

    PubMed 40532178

  • Leidner R, Crittenden M, Young K, Xiao H, Wu Y, Couey MA, Patel AA, Cheng AC, Watters AL, Bifulco C, Morris G, Rushforth L, Nemeth S, Urba WJ, Gough M, Bell RB. Neoadjuvant immunoradiotherapy results in high rate of complete pathological response and clinical to pathological downstaging in locally advanced head and neck squamous cell carcinoma. J Immunother Cancer. 2021 May;9(5):e002485. doi: 10.1136/jitc-2021-002485.

    PubMed 33963014

  • Massarelli E, William W, Johnson F, Kies M, Ferrarotto R, Guo M, Feng L, Lee JJ, Tran H, Kim YU, Haymaker C, Bernatchez C, Curran M, Zecchini Barrese T, Rodriguez Canales J, Wistuba I, Li L, Wang J, van der Burg SH, Melief CJ, Glisson B. Combining Immune Checkpoint Blockade and Tumor-Specific Vaccine for Patients With Incurable Human Papillomavirus 16-Related Cancer: A Phase 2 Clinical Trial. JAMA Oncol. 2019 Jan 1;5(1):67-73. doi: 10.1001/jamaoncol.2018.4051.

    PubMed 30267032

  • Chung V, Kos FJ, Hardwick N, Yuan Y, Chao J, Li D, Waisman J, Li M, Zurcher K, Frankel P, Diamond DJ. Evaluation of safety and efficacy of p53MVA vaccine combined with pembrolizumab in patients with advanced solid cancers. Clin Transl Oncol. 2019 Mar;21(3):363-372. doi: 10.1007/s12094-018-1932-2. Epub 2018 Aug 9.

    PubMed 30094792

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing WSK-IM05 (4×10^10 vp), WSK-IM05 (8×10^10 vp) and WSK-IM05 (1.6x10^11 vp) in people with HPV-positive Oropharyngeal Squamous Cell Carcinoma, run by West China Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xingchen Peng (18980606753, pxx2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose-Limiting Toxicities (DLTs) (time frame: First 21 days after first dose of WSK-IM05 (approximately 21 days in total)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07565740, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in