A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTheravectys S.A.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
None
Trial design
Treatments tested in this trial
- Two IM injections Lenti-HPV-07
- One IM injection Lenti-HPV-07
Treatment groups
72 Participants
are divided into 2 treatment groupsLocations
4Florida Cancer Specialists (from Sarah Canon research Institute)32827, OrlandoFlorida, United States
Moffitt Cancer Center33612, TampaFlorida, United States
Tampa General Hospital33606, TampaFlorida, United States
Oklahoma Cancer Specialists and Research Institute, LLC74146, TulsaOklahoma, United States
Sponsors and collaborators
Theravectys S.A.
Lead sponsor
Source ClinicalTrials.gov