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A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer
NCT06319963 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Two IM injections Lenti-HPV-07
- DRUG One IM injection Lenti-HPV-07
Study Locations (4)
Florida
- Florida Cancer Specialists (from Sarah Canon research Institute) — Orlando
- Tampa General Hospital — Tampa
- Moffitt Cancer Center — Tampa
Oklahoma
- Oklahoma Cancer Specialists and Research Institute, LLC — Tulsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2024-08-08 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06319963
The ClinicalTrials.gov registry entry for NCT06319963 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Theravectys S.A., which has 29 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with HPV Positive Oropharyngeal Squamous Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions — of which Two IM injections Lenti-HPV-07 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06319963 reports 4 study locations spanning 2 distinct geographic areas — top geographies include Florida, Oklahoma. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06319963 about?
NCT06319963 is a clinical study titled "A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer". 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? ...
What is the current status of trial NCT06319963?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2024-08-08. Estimated completion is 2026-12.
What conditions does trial NCT06319963 study?
This clinical trial studies the following conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma, HPV-Related Cervical Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06319963?
The interventions under investigation include: Two IM injections Lenti-HPV-07 (DRUG), One IM injection Lenti-HPV-07 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06319963?
This trial is sponsored by Theravectys S.A., which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06319963 being conducted?
This trial has 4 study locations across Florida, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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