NCT06319963RecruitingPhase 1/2
A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer
An Open-Label Phase 1/2a Clinical Trial to Evaluate the Safety, Immunogenicity, and Preliminary Efficacy of a Lentiviral Vector-Based Therapeutic Vaccine Against Human Papilloma Virus (Lenti-HPV-07) in Participants With HPV-Associated Oropharyngeal Squamous Cell Cancer or Cervical Cancer
Source: ClinicalTrials.gov · Last updated 2 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 27 Feb 2024
- Start date
- 8 Aug 2024
- Primary completion date
- Jun 2026
- Lead sponsor
- Theravectys S.A.
- Diseases
- Head and neck cancer, Cervical cancer
- NCT number
- NCT06319963
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 72
- From 8 Aug 2024 to the primary completion date, Jun 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- \- with seropositivity for HIV, active hepatitis C virus (HCV) infection, or hepatitis B (HBV) infection
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Florida Cancer Specialists (from Sarah Canon research Institute) Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Tampa General Hospital Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Oklahoma Cancer Specialists and Research Institute, LLC Coordinator of this site? Confirm its status | Tulsa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.