Clinical trial Recruiting at 4 sites Phase1; Phase2 Interventional Ages 18 and up

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

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment72 (estimated)
SponsorTheravectys S.A.
Industry-sponsored
Locations4 sites (Orlando, Florida and 3 other locations)
StatusRecruiting
StartedAugust 8, 2024
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedNovember 10, 2026
Trial IDNCT06319963 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

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.