Clinical trial NCT06319963: A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: HPV-Related Cervical Carcinoma
HPV Positive Oropharyngeal Squamous Cell Carcinoma
Keywords: 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
Lead sponsor: Theravectys S.A.
Sponsor class: INDUSTRY
First posted: 2024-03-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Safety and Tolerability
timeFrame: 12 months after last injection
measure: OBD
timeFrame: 28 days after last injection
Secondary outcomes:
measure: Immunogenicity
timeFrame: 12 months after last injection
measure: PD-L1 expression
timeFrame: 12 months after last injection
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Florida Cancer Specialists (from Sarah Canon research Institute)
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
References: