Actively Recruiting
Phase IIIa Study of BVAC-E6E7 Vaccine for Treating HPV 16 or 18 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Led by Cellid Co., Ltd. · Updated on 2026-07-08
37
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying BVAC-E6E7, an immunotherapeutic vaccine designed to treat adults with unresectable recurrent or metastatic head and neck squamous cell carcinoma that is positive for HPV types 16 or 18. This clinical trial includes two phases Phase 1 focuses on evaluating safety and tolerance to find the maximum tolerated dose, while Phase 2 assesses the vaccines effectiveness. Participants receive BVAC-E6E7 through intravenous injections every 3 weeks for a total of 6 doses. Phase 1 includes low and high dose groups receiving 2.5 x 107 and 5.0 x 107 cells per dose, respectively. Phase 2 participants receive the recommended Phase 2 dose determined from Phase 1. The study follows a sequential design without randomization. During the trial, participants undergo regular assessments including imaging scans to evaluate tumor response, laboratory tests, physical examinations, ECGs, and blood samples to monitor immune response and safety. Researchers measure outcomes such as dose-limiting toxicities, tumor response rates, disease control, progression-free survival, and overall survival over approximately 18 months. Safety and immune activity are closely monitored throughout the study period.
CONDITIONS
Brief Title
A Phase I/IIa Clinical Trial to Investigate BVAC-E6E7 in Subjects With HPV Positive HNSCC.
Research Team
W
Wu Hyun Kim, D.V.M
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