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

Phase 1

Recruiting

• Conditions: HPV-Related Cervical Carcinoma; HPV Positive Oropharyngeal Squamous Cell Carcinoma
• Interventions: Drug: Two IM injections Lenti-HPV-07; Drug: One IM injection Lenti-HPV-07

• Registration Number: NCT06319963
• Lead Sponsor: Theravectys S.A.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-27
• Study First Submitted QC: 2024-03-13
• Study First Posted: 2024-03-20
• Study Start: 2024-08-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arm A : Refractory newly diagnosed	Two IM injections Lenti-HPV-07	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).
Arm B : newly diagnosed locally advanced	One IM injection Lenti-HPV-07	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).

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability	12 months after last injection	Frequency, intensity, and relationship of adverse events with vaccine administration per CTCAE v5.0
OBD	28 days after last injection	To identify the optimal biological dose (OBD) and schedule for subsequent trials of Lenti-HPV-07

Secondary Outcome Measures

Name	Time	Method
Immunogenicity	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
PD-L1 expression	12 months after last injection	PD-L1 tumor expression, as measured by composite positive score, by 50% both pre- and post-injection

Trial Locations

Locations (3)

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

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States