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

NCT06797986 | Not Yet Recruiting Phase 1

• 1 other identifier: VIVACE-001
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

HNSCC; BVAC-E6E7; HPV Type 16 and/or 18 Positive

Outcome Measures

Primary Outcomes (6)

• [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.

  On day 1 of cycle 3 (each cycle is 21 days)

• [Part B] Objective Response Rate (ORR)

  The ratio of subjects assessed with complete response (CR) or partial response (PR) as a best overall response.

  During entire clinical trial, an average of 18 months.

• [Part B] Disease Control Rate (DCR)

  The ratio of subjects assessed with CR or PR or stable disease (SD) as a best overall response.

  During entire clinical trial, an average of 18 months.

• [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.

  From the date of objective response (CR or PR) to the date of disease progression or death, assessed up to 18 months.

• [Part B] 6-month Progression Free Survival rate (PFS rate) or PFS

  6-month PFS rate is defined as the ratio of subjects assessed with no 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.

  6-month after the first IP administration for 6-month PFS / From first IP administration to disease progression or death for PFS

• [Part B] 12-month Overall Survival rate (OS rate) or OS

  12-month OS rate is defined as the survival rate at 12-month after the first IP administration. OS is defined as the duration until death in subjects from the first IP administration.

  12-month after the first IP administration for 12-month OS rate / From first IP administration to death for OS

Secondary Outcomes (14)

• [Part A] Objective Response Rate (ORR)

  During entire clinical trial, an average of 18 months.

• [Part A] Disease Control Rate (DCR)

  During entire clinical trial, an average of 18 months.

• [Part A] Duration of Response (DOR)

  From objective response (CR or PR) to disease progression or death, assessed up to 18 months.

• [Part A] 6-month Progression Free Survival rate (PFS rate) or PFS

  6-month after the first IP administration for 6-month PFS rate / From first IP administration to disease progression or death for PFS

• [Part A] 12-month Overall Survival rate (OS rate) or OS

  12-month after the first IP administration for 12-month OS rate / From first IP administration to death for OS

Study Arms (3)

BVAC-E6E7 (low level)

EXPERIMENTAL

Part A (low level) Test group will receive low dose level (2.5 x 10\^7 cells/dose) of BVAC-E6E7 for every 3 weeks, 6 times by IV injection

Biological: BVAC-E6E7 (low level)

BVAC-E6E7 (high level)

EXPERIMENTAL

Part A (high level) Test group will receive high dose level (5.0 x 10\^7 cells/dose) of BVAC-E6E7 for every 3 weeks, 6 times by IV injection

Biological: BVAC-E6E7 (high level)

BVAC-E6E7 (RP2D)

EXPERIMENTAL

Part B Test group will receive RP2D of BVAC-E6E7 for every 3 weeks, 6 times by IV injection

Biological: BVAC-E6E7 (RP2D)

Interventions

BVAC-E6E7 (low level) BIOLOGICAL

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.

BVAC-E6E7 (low level)

BVAC-E6E7 (high level) BIOLOGICAL

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.

BVAC-E6E7 (high level)

BVAC-E6E7 (RP2D) BIOLOGICAL

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.

BVAC-E6E7 (RP2D)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Patients with ECOG performance status of 0 or 1
• Patients with at least a 3-month life expectancy.
• Male patients who has not received the vasectomy should agree usage barrier contraceptive method (i.e. condom) and agree to use appropriate contraception for themselves and their partners for at least 6 months after the completion of IP administration.
• Appropriate contraceptive method: absolute abstinence, hormone contraceptive agent with unknown drug-interaction (e.g. levonorgestrel intrauterine system (IUS) (Mirena) or Medroxyprogesterone) and surgical sterilization operation (Vasectomy, Bilateral salpingectomy and ligation, etc.). However, Intermittent abstinences (ovulation period, symptothermal method or late-ovulation) or Coitus interruptus are not considered as appropriate contraceptive method.

You may not qualify if:

• 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.
• 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.
• 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.
• ① Patients positive for HBsAg and HBV DNA.
• ② Patients positive for anti-HCV and HCV RNA.
• Patients with autoimmune disease or history of chronic or recurrent autoimmune diseases.
• Patients with a history of organ transplantation.

Sponsors & Collaborators

• Cellid Co., Ltd.: lead

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wu Hyun Kim, D.V.M

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: January 29, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 29, 2025

Record last verified: 2025-01