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
Overview
- Phase
- Phase 1
- Intervention
- Two IM injections Lenti-HPV-07
- Conditions
- HPV-Related Cervical Carcinoma
- Sponsor
- Theravectys S.A.
- Enrollment
- 72
- Locations
- 4
- Primary Endpoint
- Safety and Tolerability
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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
As of 06Nov2025 the recruitment in ARm A of the study (recurrent/metastatic cancers) has been closed to further enrollment, in accordance with the protocol and the study's prespecified operational and/or scientific considerations. No new participants will be enrolled into Arm A, and no additional study drug will be administered within this arm.
Investigators
Eligibility Criteria
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
Arms & Interventions
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).
Intervention: Two IM injections Lenti-HPV-07
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).
Intervention: One IM injection Lenti-HPV-07
Outcomes
Primary Outcomes
Safety and Tolerability
Time Frame: 12 months after last injection
Frequency, intensity, and relationship of adverse events with vaccine administration per CTCAE v5.0
OBD
Time Frame: 28 days after last injection
To identify the optimal biological dose (OBD) and schedule for subsequent trials of Lenti-HPV-07
Secondary Outcomes
- Immunogenicity(12 months after last injection)
- PD-L1 expression(12 months after last injection)