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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
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.
As of 06Nov2025 the recruitment in ARm A of the study (recurrent/metastatic cancers) has been closed to further enrollment, in accordance with the protocol and the study's prespecified operational and/or scientific considerations. No new participants will be enrolled into Arm A, and no additional study drug will be administered within this arm.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Florida Cancer Specialists (from Sarah Canon research Institute)
Orlando, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, United States
Start Date
August 8, 2024
Primary Completion Date
June 1, 2026
Completion Date
December 1, 2026
Last Updated
February 2, 2026
72
ESTIMATED participants
Two IM injections Lenti-HPV-07
DRUG
One IM injection Lenti-HPV-07
DRUG
Lead Sponsor
Theravectys S.A.
NCT05639972
NCT06640283
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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