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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
two Lenti-HPV-07 intramuscular injections one month apart
a single intramuscular injection prior to receiving a standard of care 28 days at least after the injection.
Florida Cancer Specialists (from Sarah Canon research Institute)
Orlando, Florida, United States
RECRUITINGTampa General Hospital
Tampa, Florida, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGOklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, United States
RECRUITINGSafety and Tolerability
Frequency, intensity, and relationship of adverse events with vaccine administration per CTCAE v5.0
Time frame: 12 months after last injection
OBD
To identify the optimal biological dose (OBD) and schedule for subsequent trials of Lenti-HPV-07
Time frame: 28 days after last injection
Immunogenicity
* measure of CD4+ and CD8+ T cell responses specific to E6 or E7 from HPV16 and HPV18 in PBMC * repertoire and clonotype tracking, and cytometric analysis of T cell activation/effector/memory marker
Time frame: 12 months after last injection
PD-L1 expression
PD-L1 tumor expression, as measured by composite positive score, by 50% both pre- and post-injection
Time frame: 12 months after last injection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.