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
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
Florida Cancer Specialists (from Sarah Canon research Institute)
RECRUITING
Orlando
Moffitt Cancer Center
RECRUITING
Tampa
Tampa General Hospital
RECRUITING
Tampa
Oklahoma
Oklahoma Cancer Specialists and Research Institute, LLC
RECRUITING
Tulsa
Contact Information
Primary
Daniel Loera
dloera@oncobay.com
713-256-8202
Time Frame
Start Date:2024-08-08
Estimated Completion Date:2026-12
Participants
Target number of participants:72
Treatments
Experimental: Arm A : Refractory newly diagnosed
Refractory recurrent and/or metastatic cervical or oropharyngeal cancer that is not amenable to local therapy with curative intent (ie, surgery or radiation therapy with or without chemotherapy).
Experimental: Arm B : newly diagnosed locally advanced
Participants who have newly diagnosed locally advanced HPV-related oropharyngeal cancer (defined by AJCC 8th edition \[ie, T1-2N2-N3, T3-T4N0-N3\]) or cervical cancer (stages IB to IVA) that has never been treated with curative intent, and who are candidates to begin an SoC treatment (surgery, radiation therapy with or without chemotherapy).