protocolSection identificationModule nctId: NCT06319963, orgStudyIdInfo id: Lenti-HPV-07-CT01, briefTitle: A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Theravectys S.A., class: INDUSTRY, descriptionModule briefSummary: 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 cancerAfter 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., conditionsModule conditions: HPV-Related Cervical Carcinoma, conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Phase 1/2a, open label, multicenter, dose-escalation and dose expansion trial to assess the safety, tolerability, and preliminary efficacy of Lenti-HPV-07 to participants with HPV associated oropharyngeal squamous cell cancer or cervical cancer. Three dose strengths will be investigated: a low, midlevel, and high dose. Lenti HPV-07 will be administered as either 2 × intramuscular (IM) injections to participants in arm A (recurrent or metastatic stage, refractory to previous treatments) or as a single IM injection to participants in Arm B (newly diagnosed with locally advanced HPV+ cancer never treated). Eligible participants in Arm B will receive only 1 injection of Lenti-HPV-07 prior to the initiation of their standard of care (SoC) therapy. After 18 participants in either arm have been treated in the escalation phase and have completed the 14 day DLT period, the Safety Review Committee and Sponsor will determine the OBD for use in the dose expansion phase., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Two IM injections Lenti-HPV-07, interventions name: One IM injection Lenti-HPV-07, outcomesModule primaryOutcomes measure: Safety and Tolerability, primaryOutcomes measure: OBD, secondaryOutcomes measure: Immunogenicity, secondaryOutcomes measure: PD-L1 expression, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Florida Cancer Specialists (from Sarah Canon research Institute), city: Orlando, state: Florida, zip: 32827, country: United States, contacts name: Cesar Augusto Perez Batista, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.53834, lon: -81.37924, hasResults: False