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

HPV Positive Oropharyngeal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06319963
• Other study ID #: Lenti-HPV-07-CT01
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: March 2024
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Theravectys S.A.
• Contact: Daniel Loera
• Phone: 713-256-8202
• Email: dloera[@]oncobay.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• HPV Positive Oropharyngeal Squamous Cell Carcinoma
• HPV-Related Cervical Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

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

Locations

Country	Name	City	State
United States	Florida Cancer Specialists (from Sarah Canon research Institute)	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Theravectys S.A.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability	Frequency, intensity, and relationship of adverse events with vaccine administration per CTCAE v5.0	12 months after last injection
Primary	OBD	To identify the optimal biological dose (OBD) and schedule for subsequent trials of Lenti-HPV-07	28 days after last injection
Secondary	Immunogenicity	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	12 months after last injection
Secondary	PD-L1 expression	PD-L1 tumor expression, as measured by composite positive score, by 50% both pre- and post-injection	12 months after last injection