A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTheravectys S.A.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
None
Trial design
Treatments tested in this trial
- Two IM injections Lenti-HPV-07
- One IM injection Lenti-HPV-07
Treatment groups
72 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov