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

RECRUITINGPhase 1/2Sponsored by Theravectys S.A.
Actively Recruiting
PhasePhase 1/2
SponsorTheravectys S.A.
Started2024-08-08
Est. completion2026-06
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations4 sites
View on ClinicalTrials.gov →

NCT06319963

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

CancerHPV Positive Oropharyngeal Squamous Cell CarcinomaHPV-Related Cervical Carcinoma

Locations4 sites

Florida

3 sites
Florida Cancer Specialists (from Sarah Canon research Institute)
Orlando, Florida, 32827
Cesar Augusto Perez Batista, MD
Tampa General Hospital
Tampa, Florida, 33606
Noman Ashraf, MD
Moffitt Cancer Center
Tampa, Florida, 33612
Guilherme Rabinowits, MD

Oklahoma

1 site
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, 74146
Daron Street, MD

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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