NCT06319963

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Theravectys S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HPV-Related Cervical Carcinoma
• HPV Positive Oropharyngeal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Two IM injections Lenti-HPV-07	two Lenti-HPV-07 intramuscular injections one month apart
DRUG	One IM injection Lenti-HPV-07	a single intramuscular injection prior to receiving a standard of care 28 days at least after the injection.

Timeline

• Start date: 2024-08-08
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2024-03-20
• Last updated: 2026-02-02

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study