eligibility_summary
Adults (≥18) with HPV16+ oropharyngeal (or select other site) HNSCC, AJCC8 N1 ≥3 cm, N2–N3, or T3–T4, measurable disease, ECOG 0–1, normal labs, cisplatin-eligible, provide ≥10 slides or new biopsy, consent, negative pregnancy, contraception, no breastfeeding. Exclude: M1, non-HPV16/unknown primary, prior HN RT/chemo or recent full resection, recent systemic/investigational therapy, serious comorbidity/autoimmune on immunosuppression, antibody allergy, pneumonitis, active HBV/HCV, live vaccine <28 d, immune-stimulating herbs.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05108870 tests TheraT vectors HB-201 and HB-202 plus chemotherapy for HPV16+ oropharyngeal cancer. HB-201/HB-202 are replicating arenavirus-based therapeutic cancer vaccines (viral vectors) encoding HPV16 E6/E7, they infect antigen-presenting cells to drive strong HPV16-specific CD8+ T-cell responses. Alternating HB-201/HB-202 enables a heterologous prime-boost to limit anti-vector immunity. Chemotherapy: carboplatin (platinum DNA crosslinker causing DNA adducts) and paclitaxel (taxane that stabilizes microtubules and blocks mitosis). Targets: HPV16 E6/E7-expressing tumor cells via cytotoxic T lymphocytes, dendritic/APC activation and antigen presentation, tumor DNA damage/repair pathways and mitotic spindle function. Transoral robotic surgery and risk-adapted radiotherapy/chemoradiotherapy follow.