Home › Cervical Cancer › NCT06319963
A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer
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
Who can join
Ages 18 and older · All sexes
Full eligibility 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
About the study
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.
What is being tested
- Two IM injections Lenti-HPV-07 (drug)
- One IM injection Lenti-HPV-07 (drug)
Sponsor: Theravectys S.A. · Participants: 72 · Started: Aug 8, 2024
Contact the study team
- Daniel Loera · Phone: 713-256-8202
Official record on ClinicalTrials.gov — NCT06319963
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.