A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer
Sponsor: Theravectys S.A.
ClinicalTrials ID:NCT06319963
This trial assesses the safety and immune response of Lenti-HPV-07 in HPV-related cancers. Eligible participants have confirmed invasive oropharyngeal or cervical cancer, with good organ function and ECOG 0-1. Interventions include either two IM injections a month apart or one IM injection followed by standard care after 28 days. Follow-up lasts up to one year.
Patient Parameters
| Parameter | Options |
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Program Overview
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
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Florida Cancer Specialists (from Sarah Canon research Institute) | 32827 | Orlando | Florida |
| Tampa General Hospital | 33606 | Tampa | Florida |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
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