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NCT06319963PHASE1, PHASE2Recruiting

A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer

Theravectys S.A.

Start Date

8/8/2024

Completion Date

12/1/2026

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.

Detailed 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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Two IM injections Lenti-HPV-07

DRUG

One IM injection Lenti-HPV-07

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Conditions

HPV-Related Cervical CarcinomaHPV Positive Oropharyngeal Squamous Cell Carcinoma

Locations

Florida Cancer Specialists (from Sarah Canon research Institute)

Orlando, Florida 32827

United States

Tampa General Hospital

Tampa, Florida 33606

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Oklahoma Cancer Specialists and Research Institute, LLC

Tulsa, Oklahoma 74146

United States