Actively Recruiting
An Open-Label Phase 1/2a Trial Evaluating Safety and Immune Response of Lenti-HPV-07 in HPV-Associated Oropharyngeal or Cervical Cancer
Led by Theravectys S.A. · Updated on 2026-02-02
72
Participants Needed
4
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and immune response of a new potential treatment called Lenti-HPV-07 for patients with cancers caused by Human Papilloma Virus (HPV), specifically cervical or oropharyngeal cancers. The study aims to determine if the treatment is safe and whether it stimulates the immune system. Participants will be grouped based on their cancer type, either recurrent/metastatic or newly diagnosed locally advanced cancer. Participants in this trial will receive Lenti-HPV-07 through intramuscular injections. Those with recurrent or metastatic cancer receive two injections one month apart, while newly diagnosed participants receive one injection before starting standard treatments such as surgery, radiation, or chemotherapy. After treatment, participants will be followed for up to one year through clinic visits or phone calls to monitor their health. During the study, participants will undergo safety and immune response assessments, including monitoring side effects and immune markers for up to 12 months after the last injection. Researchers will also evaluate other factors such as PD-L1 expression. The total participation includes treatment administration followed by quarterly follow-up visits or calls for one year to gather data on safety, immune response, and preliminary treatment effects.
CONDITIONS
Brief Title
A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed invasive HPV-related oropharyngeal or cervical cancer
- ECOG performance status of 0 or 1
- Adequate liver, kidney, lung, and bone marrow function
You will not qualify if you...
- Positive for HIV infection
- Active hepatitis C virus infection
- Active hepatitis B virus infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 months depending on the number of injections
Participants receive one or two intramuscular injections of Lenti-HPV-07 as part of the immunotherapy treatment.
1 to 2 visits for intramuscular injections spaced one month apart
Duration - 12 months after last injection
Participants are monitored for safety, tolerability, and immune response for up to 12 months after the last injection.
Regular follow-up visits during 12 months after last injection
Trial Site Locations
Total: 4 locations
1
Florida Cancer Specialists (from Sarah Canon research Institute)
Orlando, Florida, United States, 32827
Actively Recruiting
2
Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
4
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, United States, 74146
Actively Recruiting
Research Team
D
Daniel Loera
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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