drugset / Trial / NCT06319963

A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer

NCT06319963 ↗

Phase 1/2 Recruiting 72 enrolled Theravectys S.A.
Non-randomizedSequentialOpen-labelTreatment

Summary

The goal of this clinical trial is to learn about the safety and efficacy of a potential new treatment called Lenti-HPV-07 in patients with a cancer induced by Human Papilloma Virus (HPV). The main questions aim to answer are: * Is Lenti-HPV-07 safe? * Does Lenti-HPV-07 induce an immune response? Participants will be assigned to a group based on their cancer type * either study drug group A: recurrent and/or metastatic cancer * or study drug group B: newly diagnosed with locally advanced cancer After they finish the study treatment, they will be followed for up to 1 year. Follow-up visits will occur via clinic visits or phone calls 4 weeks after the last study treatment and then quarterly for up to 1 year.

Timeline

Start
2024-08-08
Primary completion
2026-06
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenti-HPV-07 Vaccine — Intramuscular