A Phase I/IIa Clinical Trial to Investigate BVAC-E6E7 in Subjects with HPV Positive HNSCC. (NCT06797986) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Phase I/IIa Clinical Trial to Investigate BVAC-E6E7 in Subjects with HPV Positive HNSCC.
37 participantsStarted 2025-03
Plain-language 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: Phaseâ… focuses on safety and tolerance to determine the maximum tolerated dose (MTD), while Phase â…¡ evaluates its efficacy.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Adult male and female aged 19 and above at the time of acquisition informed consent form.
✓. Patients who have agreed to provide blood and tissue samples during the clinical trial.
✓. 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.
✓. Patients who are histologically or cytologically diagnosed with recurrent/metastatic Head and neck squamous cell carcinoma (excluding Nasopharyngeal carcinoma).
✓. Patients with at least one measurable or evaluable lesion confirmed by CT or MRI according to RECIST v1.1. \[It can be considered as an evaluable lesion if the disease has progressed in the previously irradiated area.\]
✓. Patients who meet one of the following criteria and have no available standard treatment due to contraindication, intolerance or refusal of administration.
✓. Patients with ECOG performance status of 0 or 1
✓. Patients with at least a 3-month life expectancy.
Exclusion criteria
✕. 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.)
What they're measuring
1
[Part A] Incidence of dose-limiting toxicity (DLT) after BVAC-E6E7 administration
Timeframe: On day 1 of cycle 3 (each cycle is 21 days)
2
[Part B] Objective Response Rate (ORR)
Timeframe: During entire clinical trial, an average of 18 months.
3
[Part B] Disease Control Rate (DCR)
Timeframe: During entire clinical trial, an average of 18 months.
4
[Part B] Duration of Response (DOR)
Timeframe: From the date of objective response (CR or PR) to the date of disease progression or death, assessed up to 18 months.
✕. Nasopharyngeal cancer or Head and neck cancer other than squamous cell carcinoma.
✕. Patients having below cardiovascular disease at the time of the screening process.
✕. 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.)
✕. 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) \[However, alternative treatment (thyroxine, insulin, physiologic corticosteroid alternative treatment due to dysfunction of adrenal gland or pituitary gland) are not considered as systemic treatments.\]
✕. 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.
✕. Patients with a positive human immunodeficiency virus (HIV) test result
✕. Patients with active hepatitis B or C according to the hepatitis B virus (HBV) and hepatitis C virus (HCV) test result.