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

NCT ID: NCT06319963

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-08

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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HPV-Related Cervical Carcinoma HPV Positive Oropharyngeal Squamous Cell Carcinoma

Keywords

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Phase 1/2a, open label, multicenter, dose-escalation and dose expansion trial to assess the safety, tolerability, and preliminary efficacy of Lenti-HPV-07 to participants with HPV associated oropharyngeal squamous cell cancer or cervical cancer. Three dose strengths will be investigated: a low, midlevel, and high dose. Lenti HPV-07 will be administered as either 2 × intramuscular (IM) injections to participants in arm A (recurrent or metastatic stage, refractory to previous treatments) or as a single IM injection to participants in Arm B (newly diagnosed with locally advanced HPV+ cancer never treated). Eligible participants in Arm B will receive only 1 injection of Lenti-HPV-07 prior to the initiation of their standard of care (SoC) therapy. After 18 participants in either arm have been treated in the escalation phase and have completed the 14 day DLT period, the Safety Review Committee and Sponsor will determine the OBD for use in the dose expansion phase.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Two IM injections Lenti-HPV-07

Intervention Type DRUG

two Lenti-HPV-07 intramuscular injections one month apart

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).

Group Type EXPERIMENTAL

One IM injection Lenti-HPV-07

Intervention Type DRUG

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

Interventions

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Two IM injections Lenti-HPV-07

two Lenti-HPV-07 intramuscular injections one month apart

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Theravectys S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Florida Cancer Specialists (from Sarah Canon research Institute)

Orlando, Florida, United States

Site Status RECRUITING

Tampa General Hospital

Tampa, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Oklahoma Cancer Specialists and Research Institute, LLC

Tulsa, Oklahoma, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Daniel Loera

Role: CONTACT

Phone: 713-256-8202

Email: [email protected]

Other Identifiers

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Lenti-HPV-07-CT01

Identifier Type: -

Identifier Source: org_study_id