[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06319963":3,"trial-entities:NCT06319963":134,"trial-summary:NCT06319963":141},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":33,"primary_purpose":34,"phases":35,"enrollment_info":38,"interventions":41,"primary_outcomes":53,"secondary_outcomes":62,"sex":69,"minimum_age":70,"maximum_age":71,"healthy_volunteers":72,"eligibility_criteria":73,"std_ages":80,"locations":83,"central_contacts":125,"overall_officials":131,"references":132,"see_also_links":133},"NCT06319963","Lenti-HPV-07-CT01","A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer","An Open-Label Phase 1\u002F2a 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","RECRUITING","2026-12","2026-01","2026-02-02","2024-08-08","Theravectys S.A.","INDUSTRY",true,"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).\n\nThe main questions aim to answer are:\n\n* Is Lenti-HPV-07 safe?\n* Does Lenti-HPV-07 induce an immune response?\n\nParticipants will be assigned to a group based on their cancer type\n\n* either study drug group A: recurrent and\u002For metastatic cancer\n* or study drug group B: newly diagnosed with locally advanced cancer\n\nAfter 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.","As of 06Nov2025 the recruitment in ARm A of the study (recurrent\u002Fmetastatic cancers) has been closed to further enrollment, in accordance with the protocol and the study's prespecified operational and\u002For scientific considerations. No new participants will be enrolled into Arm A, and no additional study drug will be administered within this arm.",[19,20],"HPV-Related Cervical Carcinoma","HPV Positive Oropharyngeal Squamous Cell Carcinoma",[22,23,24,25,26,27,28,29,30,31,32],"HPV16","Cervical Cancer","Oropharyngeal cancer","Immuno-oncotherapy","Head and Neck Cancers","T-cell vaccine","Lentiviral Vector","Anti-tumor immunity","Early E- and E7 antigens","HPV18","Human Papillomavirus","INTERVENTIONAL","TREATMENT",[36,37],"PHASE1","PHASE2",{"count":39,"type":40},72,"ESTIMATED",[42,48],{"type":43,"name":44,"description":45,"armGroupLabels":46},"DRUG","Two IM injections Lenti-HPV-07","two Lenti-HPV-07 intramuscular injections one month apart",[47],"Arm A : Refractory newly diagnosed",{"type":43,"name":49,"description":50,"armGroupLabels":51},"One IM injection Lenti-HPV-07","a single intramuscular injection prior to receiving a standard of care 28 days at least after the injection.",[52],"Arm B : newly diagnosed locally advanced",[54,58],{"measure":55,"description":56,"timeFrame":57},"Safety and Tolerability","Frequency, intensity, and relationship of adverse events with vaccine administration per CTCAE v5.0","12 months after last injection",{"measure":59,"description":60,"timeFrame":61},"OBD","To identify the optimal biological dose (OBD) and schedule for subsequent trials of Lenti-HPV-07","28 days after last injection",[63,66],{"measure":64,"description":65,"timeFrame":57},"Immunogenicity","* measure of CD4+ and CD8+ T cell responses specific to E6 or E7 from HPV16 and HPV18 in PBMC\n* repertoire and clonotype tracking, and cytometric analysis of T cell activation\u002Feffector\u002Fmemory marker",{"measure":67,"description":68,"timeFrame":57},"PD-L1 expression","PD-L1 tumor expression, as measured by composite positive score, by 50% both pre- and post-injection","ALL","18 Years",null,false,{"inclusion":74,"exclusion":78,"raw_text":79},[75,76,77],"histologically confirmed invasive HPV-related oropharyngeal or cervical cancer","ECOG performance status of 0 or 1","adequate hepatic, renal, pulmonary, and bone marrow\u002Fhematological function",[],"Inclusion Criteria:\n\n* histologically confirmed invasive HPV-related oropharyngeal or cervical cancer\n* ECOG performance status of 0 or 1\n* adequate hepatic, renal, pulmonary, and bone marrow\u002Fhematological function\n\nExclusion Criteria:\n\n\\- with seropositivity for HIV, active hepatitis C virus (HCV) infection, or hepatitis B (HBV) infection",[81,82],"ADULT","OLDER_ADULT",[84,97,107,114],{"facility":85,"status":8,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":94},"Florida Cancer Specialists (from Sarah Canon research Institute)","Orlando","Florida","32827","United States",[91],{"name":92,"role":93},"Cesar Augusto Perez Batista, MD","PRINCIPAL_INVESTIGATOR",{"lat":95,"lon":96},28.53834,-81.37924,{"facility":98,"status":8,"city":99,"state":87,"zip":100,"country":89,"contacts":101,"geoPoint":104},"Tampa General Hospital","Tampa","33606",[102],{"name":103,"role":93},"Noman Ashraf, MD",{"lat":105,"lon":106},27.94752,-82.45843,{"facility":108,"status":8,"city":99,"state":87,"zip":109,"country":89,"contacts":110,"geoPoint":113},"Moffitt Cancer Center","33612",[111],{"name":112,"role":93},"Guilherme Rabinowits, MD",{"lat":105,"lon":106},{"facility":115,"status":8,"city":116,"state":117,"zip":118,"country":89,"contacts":119,"geoPoint":122},"Oklahoma Cancer Specialists and Research Institute, LLC","Tulsa","Oklahoma","74146",[120],{"name":121,"role":93},"Daron Street, MD",{"lat":123,"lon":124},36.15398,-95.99277,[126],{"name":127,"role":128,"phone":129,"email":130},"Daniel Loera","CONTACT","713-256-8202","dloera@oncobay.com",[],[],[],{"nct_id":4,"conditions":135,"biomarkers":139},[136,137,138],"Cervical Carcinoma","Oropharyngeal Carcinoma","Solid Neoplasm",[140],"HPV",{"nct_id":4,"found":15,"summary":142,"prompt_version":152},{"design":143,"status":144,"heading":145,"summary":146,"follow_up":147,"word_count":148,"commitments":149,"compensation":150,"drugs_mentioned":151},"This study is an interventional trial planning to enroll 72 participants. Participants will be assigned to a group based on their cancer type.","completed","Lenti-HPV-07 for HPV-Related Cervical or Oropharyngeal Cancer","This study is testing a new treatment called Lenti-HPV-07 for people with cervical or oropharyngeal (throat) cancer caused by Human Papilloma Virus (HPV). Researchers want to see if Lenti-HPV-07 is safe and if it can trigger an immune response in your body. You would receive either one or two intramuscular (IM) injections of Lenti-HPV-07. To join, you need to have HPV-related cervical or oropharyngeal cancer that has been confirmed by a biopsy, and generally be in good health. The study is no longer enrolling participants with recurrent or metastatic (cancer that has spread) cancer, but may still be enrolling those with newly diagnosed, locally advanced cancer. After treatment, you would be followed for up to one year to check on your health.","Participants will be followed for up to 12 months after their last injection.",122,"You would receive either one or two intramuscular injections of Lenti-HPV-07. After treatment, you would have follow-up visits or phone calls for up to one year.","Not stated in the trial record.",[],"v2"]