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NCT Number: NCT06319963

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

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.

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Key information

Conditions

HPV-Related Cervical Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HPV Positive Oropharyngeal Squamous Cell Carcinoma Head and Neck Neoplasms Neoplasms Neoplasms by Site Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Florida Cancer Specialists (from Sarah Canon research Institute), Orlando, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Two IM injections Lenti-HPV-07

Drug

two Lenti-HPV-07 intramuscular injections one month apart

One IM injection Lenti-HPV-07

Drug

a single intramuscular injection prior to receiving a standard of care 28 days at least after the injection.

Primary outcomes

  1. Safety and Tolerability

    Time frame: 12 months after last injection

    Frequency, intensity, and relationship of adverse events with vaccine administration per CTCAE v5.0

  2. OBD

    Time frame: 28 days after last injection

    To identify the optimal biological dose (OBD) and schedule for subsequent trials of Lenti-HPV-07

Secondary outcomes

  1. Immunogenicity

    Time frame: 12 months after last injection

    • 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

  2. PD-L1 expression

    Time frame: 12 months after last injection

    PD-L1 tumor expression, as measured by composite positive score, by 50% both pre- and post-injection

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Loera

CONTACT

[email protected]

713-256-8202

Sponsors and collaborators

Lead sponsor

Theravectys S.A.

Industry

Registry information

Official study title

An Open-Label Phase 1/2a Clinical Trial to Evaluate the Safety, Immunogenicity, and Preliminary Efficacy of a Lentiviral Vector-Based Therapeutic Vaccine Against Human Papilloma Virus (Lenti-HPV-07) in Participants With HPV-Associated Oropharyngeal Squamous Cell Cancer or Cervical Cancer

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2024
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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