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.
Description
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.
Eligibility
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
