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A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer
Sponsor: Theravectys S.A.
Summary
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2024-08-08
Completion Date
2026-12
Last Updated
2026-02-02
Healthy Volunteers
No
Interventions
Two IM injections Lenti-HPV-07
two Lenti-HPV-07 intramuscular injections one month apart
One IM injection Lenti-HPV-07
a single intramuscular injection prior to receiving a standard of care 28 days at least after the injection.
Locations (4)
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