Lenti-HPV-07 for HPV-Related Cervical or Oropharyngeal Cancer

This study is testing a new treatment called Lenti-HPV-07 for people with cervical or oropharyngeal (throat) cancer caused by Human Papilloma Virus (HPV). Researchers want to see if Lenti-HPV-07 is safe and if it can trigger an immune response in your body. You would receive either one or two intramuscular (IM) injections of Lenti-HPV-07. To join, you need to have HPV-related cervical or oropharyngeal cancer that has been confirmed by a biopsy, and generally be in good health. The study is no longer enrolling participants with recurrent or metastatic (cancer that has spread) cancer, but may still be enrolling those with newly diagnosed, locally advanced cancer. After treatment, you would be followed for up to one year to check on your health.

Study design
This study is an interventional trial planning to enroll 72 participants. Participants will be assigned to a group based on their cancer type.
What's involved
You would receive either one or two intramuscular injections of Lenti-HPV-07. After treatment, you would have follow-up visits or phone calls for up to one year.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 12 months after their last injection.

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NCT06319963

A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Theravectys S.A.
~72 participants
Updated 2026-02-02 on ClinicalTrials.gov
What's tested:Two IM injections Lenti-HPV-07One IM injection Lenti-HPV-07

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability
Measured over 12 months after last injection
+1 more outcome measured
HPV-Related Cervical Carcinoma
HPV Positive Oropharyngeal Squamous Cell Carcinoma
4 sites across 2 states
Florida3
Oklahoma1

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
  • Safety and Tolerability12 months after last injection

    Frequency, intensity, and relationship of adverse events with vaccine administration per CTCAE v5.0

  • OBD28 days after last injection

    To identify the optimal biological dose (OBD) and schedule for subsequent trials of Lenti-HPV-07