A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer
Recruiting now · Phase 1/Phase 2
Conditions studied: HPV-Related Cervical Carcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma
In brief
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.
Key facts
- Study ID
- NCT06319963
- Run by
- Theravectys S.A.
- People needed
- 72
- Starts
- 2024-08-08
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-02-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- with seropositivity for HIV, active hepatitis C virus (HCV) infection, or hepatitis B (HBV) infection
Where it is running
- Florida Cancer Specialists (from Sarah Canon research Institute) — Orlando, Florida, United States (enrolling)
- Tampa General Hospital — Tampa, Florida, United States (enrolling)
- Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
- Oklahoma Cancer Specialists and Research Institute, LLC — Tulsa, Oklahoma, United States (enrolling)
Full record on ClinicalTrials.gov
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