Recruiting
Phase 1
Phase 2

Lenti-HPV-07

Sponsor:

Theravectys S.A.

Code:

NCT06319963

Conditions

HPV-Related Cervical Carcinoma

HPV Positive Oropharyngeal Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Two IM injections Lenti-HPV-07

One IM injection Lenti-HPV-07

Study Details

Brief 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.

Conditions

HPV-Related Cervical Carcinoma

HPV Positive Oropharyngeal Squamous Cell Carcinoma

Study ID

NCT06319963

Start date

Aug 8, 2024

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

72 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A : Refractory newly diagnosed

Refractory recurrent and/or metastatic cervical or oropharyngeal cancer that is not amenable to local therapy with curative intent (ie, surgery or radiation therapy with or without chemotherapy).

experimental: Arm B : newly diagnosed locally advanced

Participants who have newly diagnosed locally advanced HPV-related oropharyngeal cancer (defined by AJCC 8th edition \[ie, T1-2N2-N3, T3-T4N0-N3\]) or cervical cancer (stages IB to IVA) that has never been treated with curative intent, and who are candidates to begin an SoC treatment (surgery, radiation therapy with or without chemotherapy).

Interventions

Two IM injections Lenti-HPV-07

two Lenti-HPV-07 intramuscular injections one month apart

One IM injection Lenti-HPV-07

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

Primary outcome measure

  • Safety and Tolerability [ Time Frame: 12 months after last injection ]
  • OBD [ Time Frame: 28 days after last injection ]

Central Contacts and Locations

Central contacts

Daniel Loera

713-256-8202dloera@oncobay.com

Locations

Florida Cancer Specialists (from Sarah Canon research Institute)

Recruiting

Orlando, Florida, United States, 32827

Principal Investigator:

Cesar Augusto Perez Batista, MD

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Principal Investigator:

Noman Ashraf, MD

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Principal Investigator:

Guilherme Rabinowits, MD

Oklahoma Cancer Specialists and Research Institute, LLC

Recruiting

Tulsa, Oklahoma, United States, 74146

Principal Investigator:

Daron Street, MD

More Information

Sponsor

Theravectys S.A.

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Keywords

  • HPV16
  • Cervical Cancer
  • Oropharyngeal cancer
  • Immuno-oncotherapy
  • Head and Neck Cancers
  • T-cell vaccine
  • Lentiviral Vector
  • Anti-tumor immunity
  • Early E- and E7 antigens
  • HPV18
  • Human Papillomavirus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Theravectys S.A. on 2026-02-02.