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A Phase I/IIa Clinical Trial to Investigate BVAC-E6E7 in Subjects with HPV Positive HNSCC. | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1/PHASE2

A Phase I/IIa Clinical Trial to Investigate BVAC-E6E7 in Subjects with HPV Positive HNSCC.

A Phase I/IIa Clinical Trial to Investigate the Safety, Immunogenicity and Efficacy of BVAC-E6E7 in Subjects with HPV Type 16 And/or 18 Positive Unresectable Recurrent or Metastatic Head

NCT06797986•Cellid Co., Ltd.

View on ClinicalTrials.gov

Summary

BVAC-E6E7 is an immunotherapeutic vaccine designed to treat unresectable recurrent or metastatic head and neck squamous cell carcinoma positive to HPV 16 or 18. This clinical trial for BVAC-E6E7 consists of two phases: PhaseⅠfocuses on safety and tolerance to determine the maximum tolerated dose (MTD), while Phase Ⅱ evaluates its efficacy.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adult male and female aged 19 and above at the time of acquisition informed consent form.
•2. Patients who have agreed to provide blood and tissue samples during the clinical trial.
•3. Patients with Head and neck squamous cell carcinoma histologically confirmed as HPV type 16 or 18 positive \* The biopsy results obtained during screening process or the genotyping (PCR, microarray test) results from stored tissue (formalin-fixed paraffin-embedded) prior to screening should be confirmed positive to HPV type 16 or 18.
•4. Patients who are histologically or cytologically diagnosed with recurrent/metastatic Head and neck squamous cell carcinoma (excluding Nasopharyngeal carcinoma).
•5. Patients with at least one measurable or evaluable lesion confirmed by CT or MRI according to RECIST v1.1. \[It can be considered as an evaluable lesion if the disease has progressed in the previously irradiated area.\]
•6. Patients who meet one of the following criteria and have no available standard treatment due to contraindication, intolerance or refusal of administration.
•① Patients who have progressed or recurred the cancer during or after the completion of primary or subsequent platinum based palliative systemic chemotherapy to treat the recurrent or metastatic Head and neck cancer.
•② Patients who have confirmed the progression of cancer within 24 weeks after the final administration of immune checkpoint blocker (ICI) or completion of combination treatment including platinum agents with a radical purpose.
•③ Patients who are ineligible for platinum based chemotherapy due to contraindications, intolerance or refusal of administration of platinum based chemotherapy.
•7. Patients with ECOG performance status of 0 or 1
+3 more criteria

Exclusion Criteria

•1. Patients with a history of malignant tumor, excluding Head and neck squamous cell carcinoma, within 3 years prior to the screening (However, patients who are judged by investigator to have been cured of Basal cell carcinoma (BCC) / Squamous cell carcinoma (SCC) of the skin, localized prostate cancer, papillary thyroid cancer, or cervical intraepithelial neoplasia (CIN) are able to enroll.)
•2. Nasopharyngeal cancer or Head and neck cancer other than squamous cell carcinoma.
•3. Patients having below cardiovascular disease at the time of the screening process.
•① Myocardial infarction or Unstable angina within 6 months prior to the first IP administration (baseline).
•* Severe heart failure or congestive heart failure of class Ⅲ or higher according to the New York Heart Association (NYHA).
•* Ventricular arrhythmia requiring treatment. ④ Severe conduction disorder (e.g. 3rd degree AV block) ⑤ Uncontrolled hypertension according to the judgement by investigator.
•4. Patients who have confirmed clinically significant symptoms or uncontrolled central nervous system, brain metastasis, or carcinomatous meningitis (However, patients who have not confirmed the progression disease for at least 4 weeks after central nervous system or metastatic brain treatment and have not required treatment using steroid or other meditation within 7 days prior to the IP administration can be enrolled.)
•5. Patients with a history or confirmed active immune disease (e.g. rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, multiple sclerosis, or T cell lymphoma) after receiving systemic treatment (e.g. disease-modifying agent, corticosteroid or immunosuppressive drug) \[However, alternative treatment (thyroxine, insulin, physiologic corticosteroid alternative treatment due to dysfunction of adrenal gland or pituitary gland) are not considered as systemic treatments.\]
•6. Patients who are unable to collect the blood for production of the IP, according to the judgement of investigator, due to thromboembolism disease or bleeding diatheses.
•7. Patients with a positive human immunodeficiency virus (HIV) test result
+24 more criteria

Key Dates

Start Date

March 1, 2025

Primary Completion Date

March 1, 2027

Completion Date

March 1, 2027

Last Updated

January 29, 2025

Enrollment

ESTIMATED participants

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)HPV (human Papillomavirus)-Associated CarcinomaHPV Positive Oropharyngeal Squamous Cell Carcinoma

Interventions

BVAC-E6E7 (low level)

BIOLOGICAL

BVAC-E6E7 (high level)

BIOLOGICAL

BVAC-E6E7 (RP2D)

BIOLOGICAL

Contacts

Wu Hyun Kim, D.V.M

CONTACT

02-3285-7863 whkim@cellid.co.kr

E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers

NCT05639972

HPV-Associated Cervical CarcinomaHPV-Related Carcinoma+15 more

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RECRUITINGPHASE2

Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer

NCT04080804

Head and Neck Squamous Cell Carcinoma (HNSCC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase I/IIa Clinical Trial to Investigate BVAC-E6E7 in Subjects with HPV Positive HNSCC.

Inclusion Criteria

Exclusion Criteria

E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers

Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer

A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer

Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)

Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study