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

NCT06319963 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-02-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Theravectys S.A.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-08
Primary Completion
2026-06-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06319963 on ClinicalTrials.gov