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

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.

Trial Details

NCT ID
NCT06797986
Phase
PHASE1 / PHASE2
Sponsor
Cellid Co., Ltd.
Status
RECRUITING
Cancer Type
HPV Positive Head and Neck Cancer
Interventions
  • BVAC-E6E7 (low level)
  • BVAC-E6E7 (high level)
  • BVAC-E6E7 (RP2D)
Locations (sample)
  • Seoul, South Korea|37.566,126.9784
  • Seoul, South Korea|37.566,126.9784

Key Eligibility 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 sc…
  • Patients who are histologically or cytologically diagnosed with recurrent/metastatic Head and neck squamous cell carcinoma (excluding Nasopharyngea…

For full eligibility, visit ClinicalTrials.gov.

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