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NCT06319963 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer
A Phase 1 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and HPV-Related Cervical Carcinoma, sponsored by Theravectys S.A..
- Recruiting
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 4
- Study locations
NCT06319963: Recruiting Phase 1 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and HPV-Related Cervical Carcinoma, sponsored by Theravectys S.A..
NCT06319963 is a Phase 1 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and HPV-Related Cervical Carcinoma that is actively recruiting participants, run by Theravectys S.A.. The registered enrollment target is 72 participants, below the 87-participant average among 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials with a reported enrollment target (17% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06319963, a Phase 1 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma and HPV-Related Cervical Carcinoma, is actively recruiting participants, sponsored by Theravectys S.A..
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 4
- Study locations
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.
Primary Outcome
Frequency, intensity, and relationship of adverse events with vaccine administration per CTCAE v5.0
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 |
What NCT06319963 shows while recruiting
NCT06319963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 87-participant average among 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials with a reported enrollment target (17% lower).
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.
NCT06319963 reports a single indexed study location in Florida, Oklahoma.
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.
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).
Who is sponsoring clinical trial NCT06319963?
This trial is sponsored by Theravectys S.A., which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for HPV Positive Oropharyngeal Squamous Cell Carcinoma
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Where NCT06319963's enrollment target sits among peer trials
72 10th of 16 higher than 7 of 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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