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.
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 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.)
Nasopharyngeal cancer or Head and neck cancer other than squamous cell carcinoma.
Patients having below cardiovascular disease at the time of the screening process.
Severe heart failure or congestive heart failure of class Ⅲ or higher according to the New York Heart Association (NYHA).
Sequential
BVAC-E6E7 (low level)
Biological/VaccineBVAC-E6E7 is an immunotherapeutic vaccine designed to treat unresectable recurrent or metastatic head and neck squamous cell carcinoma positive to HPV 16 or 18.
BVAC-E6E7 (high level)
Biological/VaccineBVAC-E6E7 is an immunotherapeutic vaccine designed to treat unresectable recurrent or metastatic head and neck squamous cell carcinoma positive to HPV 16 or 18.
BVAC-E6E7 (RP2D)
Biological/VaccineBVAC-E6E7 is an immunotherapeutic vaccine designed to treat unresectable recurrent or metastatic head and neck squamous cell carcinoma positive to HPV 16 or 18.
[Part A] Incidence of dose-limiting toxicity (DLT) after BVAC-E6E7 administration
The DLT assessment criteria are based on NCI-CTCAE v5.0. The assessment includes individual criteria for hematologic/non-hematologic toxicities and other toxicities. DLT (dose-limiting toxicity) is defined as adverse events or abnormal laboratory values that limit the IP's dose-escalation and are not related to disease progression or intercurrent disease.
[Part B] Objective Response Rate (ORR)
The ratio of subjects assessed with complete response (CR) or partial response (PR) as a best overall response.
[Part B] Disease Control Rate (DCR)
The ratio of subjects assessed with CR or PR or stable disease (SD) as a best overall response.
[Part B] Duration of Response (DOR)
Duration from objective response (CR or PR) to disease progression or death in subjects assessed with CR or PR as a best overall response.
[Part A] Objective Response Rate (ORR)
The ratio of subjects assessed with complete response (CR) or partial response (PR) as a best overall response.
[Part A] Disease Control Rate (DCR)
The ratio of subjects assessed with CR or PR or stable disease (SD) as a best overall response.
[Part A] Duration of Response (DOR)
Duration from objective response (CR or PR) to disease progression or death in subjects assessed with CR or PR as a best overall response.
[Part A] 6-month Progression Free Survival rate (PFS rate) or PFS
6-month PFS rate is defined as the ratio of subjects assessed with disease progression or death at 6 months after the first IP administration. PFS is defined as the duration until disease progression or death in subjects from the first IP administration.
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