Evaluating Lenti-HPV-07 Immunotherapy for HPV-Related Cancers
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
This study is testing a new immunotherapy called Lenti-HPV-07 to see if it can safely help people with cervical or throat cancers related to HPV.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Theravectys S.A. Industry-sponsored |
| Locations | 4 sites (Orlando, Florida and 3 other locations) |
| Trial ID | NCT06319963 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and efficacy of Lenti-HPV-07, a new immunotherapy treatment for patients with HPV-related cervical or oropharyngeal cancers. Participants will be divided into two groups based on their cancer type: those with recurrent or metastatic cancer and those newly diagnosed with locally advanced cancer. The study will involve administering multiple injections of the treatment and will include follow-up visits for up to one year to monitor patient outcomes and immune responses.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed invasive HPV-related cervical or oropharyngeal cancer and an ECOG performance status of 0 or 1.
Not a fit: Patients with seropositivity for HIV or active hepatitis infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel immunotherapy option for patients suffering from HPV-related cancers.
How similar studies have performed: Other studies have shown promise with immunotherapy approaches for HPV-related cancers, suggesting potential for success in this novel treatment.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Orlando, Florida and 3 other locations
- Florida Cancer Specialists (from Sarah Canon research Institute) — Orlando, Florida, United States (Recruiting)
- Tampa General Hospital — Tampa, Florida, United States (Recruiting)
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
- Oklahoma Cancer Specialists and Research Institute, LLC — Tulsa, Oklahoma, United States (Recruiting)
Study contacts
- Study coordinator: Daniel Loera
- Email: dloera@oncobay.com
- Phone: 713-256-8202
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.