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

NCT06319963 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: Lenti-HPV-07-CT01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 4

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

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

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability

  Frequency, intensity, and relationship of adverse events with vaccine administration per CTCAE v5.0

  12 months after last injection

• OBD

  To identify the optimal biological dose (OBD) and schedule for subsequent trials of Lenti-HPV-07

  28 days after last injection

Secondary Outcomes (2)

• Immunogenicity

  12 months after last injection

• PD-L1 expression

  12 months after last injection

Study Arms (2)

Arm A : Refractory newly diagnosed

EXPERIMENTAL

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).

Drug: Two IM injections Lenti-HPV-07

Arm B : newly diagnosed locally advanced

EXPERIMENTAL

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).

Drug: One IM injection Lenti-HPV-07

Interventions

Two IM injections Lenti-HPV-07 DRUG

two Lenti-HPV-07 intramuscular injections one month apart

Arm A : Refractory newly diagnosed

One IM injection Lenti-HPV-07 DRUG

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

Arm B : newly diagnosed locally advanced

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- with seropositivity for HIV, active hepatitis C virus (HCV) infection, or hepatitis B (HBV) infection

Sponsors & Collaborators

• Theravectys S.A.: lead

Study Sites (4)

Florida Cancer Specialists (from Sarah Canon research Institute)

Orlando, Florida, 32827, United States

RECRUITING

Tampa General Hospital

Tampa, Florida, 33606, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Oklahoma Cancer Specialists and Research Institute, LLC

Tulsa, Oklahoma, 74146, United States

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Oropharyngeal Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Daniel Loera

CONTACT

713-256-8202; dloera@oncobay.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 20, 2024
• Study Start: August 8, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

US (4)