Evaluating Lenti-HPV-07 Immunotherapy for HPV-Related Cancers
Official title: 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
Run by Theravectys S.A. · NCT06319963 · Data updated 2026-11-12
This study is testing a new immunotherapy called Lenti-HPV-07 to see if it can safely help people with cervical or throat cancers related to HPV.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 72 (estimated) |
| Sponsor | Theravectys S.A. Industry-sponsored |
| Locations | 4 sites (Orlando, Florida and 3 other locations) |
| Status | Recruiting |
| Started | August 8, 2024 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT06319963 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with histologically confirmed invasive HPV-related cervical or oropharyngeal cancer and an ECOG performance status of 0 or 1.
✕Probably not a fit
Patients with seropositivity for HIV or active hepatitis infections may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to assess the safety and efficacy of Lenti-HPV-07, a new immunotherapy treatment for patients with HPV-related cervical or oropharyngeal cancers. Participants will be divided into two groups based on their cancer type: those with recurrent or metastatic cancer and those newly diagnosed with locally advanced cancer. The study will involve administering multiple injections of the treatment and will include follow-up visits for up to one year to monitor patient outcomes and immune responses.
Why it matters
Potential benefit: If successful, this treatment could provide a novel immunotherapy option for patients suffering from HPV-related cancers.
How similar studies have gone: Other studies have shown promise with immunotherapy approaches for HPV-related cancers, suggesting potential for success in this novel treatment.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Florida Cancer Specialists (from Sarah Canon research Institute)
Orlando, Florida, United States Recruiting -
Tampa General Hospital
Tampa, Florida, United States Recruiting -
Moffitt Cancer Center
Tampa, Florida, United States Recruiting -
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, United States Recruiting
Study contacts
- Study coordinator: Anastasia DEMIDOV
- Email: ademidova@theravectys.com
- Phone: +33
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Immunotherapy using E7 TCR-T cells for HPV-related cancers
This study is testing a new immunotherapy using E7 TCR-T cells to see if it can help people with advanced HPV-related cancers like cervical and throat cancer feel better and improve their health.
-
Intranasal WSK-IM05 vaccine plus tislelizumab before surgery for HPV‑positive oropharyngeal cancer
This phase I trial will see if an intranasal WSK‑IM05 vaccine given with the PD‑1 drug tislelizumab before surgery helps people with resectable HPV‑positive oropharyngeal cancer.
-
Lowering nodal and primary tumor radiation dose in HPV-positive oropharyngeal cancer
This phase II study tests whether reducing radiation doses to regions without visible cancer, while keeping the main tumor dose the same, can treat HPV-positive OPSCC with fewer side effects.
-
Selective dose reduction of neck radiation in HPV-associated oropharyngeal cancer
This trial tests whether lowering radiation doses to certain neck lymph nodes or gross disease areas is safe and can reduce side effects for adults with HPV-related oropharyngeal cancer.
-
CUE-101 with pembrolizumab for locally advanced HPV‑16 positive oropharyngeal cancer
This trial tests whether CUE-101 alone or combined with pembrolizumab before definitive therapy helps people with newly diagnosed, locally advanced HPV‑16 positive oropharyngeal cancer who are HLA‑A*02:01 positive.
-
Sacituzumab govitecan plus cetuximab for recurrent or metastatic head and neck squamous cell cancer
This trial will test whether combining sacituzumab govitecan with cetuximab works and is safe for people whose head and neck squamous cell cancer has returned or spread after prior immunotherapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.