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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllTheravectys S.A.
NCT06319963 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * histologically confirmed invasive HPV-related oropharyngeal or cervical cancer * ECOG performance status of 0 or 1 * adequate hepatic, renal, pulmonary, and bone marrow/hematological function Exclusion Criteria: \- with seropositivity for HIV, active hepatitis C virus (HCV) infection, or hepatitis B (HBV) infection
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What it tests

  • Two IM injections Lenti-HPV-07
  • One IM injection Lenti-HPV-07
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Where

4 sites
Florida Cancer Specialists (from Sarah Canon research Institute)
Orlando, United States
Tampa General Hospital
Tampa, United States
Moffitt Cancer Center
Tampa, United States
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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