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Trial Title: A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer

NCT ID: NCT06319963

Condition: HPV-Related Cervical Carcinoma
HPV Positive Oropharyngeal Squamous Cell Carcinoma

Conditions: Official terms:
Carcinoma
Squamous Cell Carcinoma of Head and Neck

Conditions: 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

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

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

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Two IM injections Lenti-HPV-07
Description: two Lenti-HPV-07 intramuscular injections one month apart
Arm group label: Arm A : Refractory newly diagnosed

Intervention type: Drug
Intervention name: One IM injection Lenti-HPV-07
Description: a single intramuscular injection prior to receiving a standard of care 28 days at least after the injection.
Arm group label: Arm B : newly diagnosed locally advanced

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Florida Cancer Specialists (from Sarah Canon research Institute)

Address:
City: Orlando
Zip: 32827
Country: United States

Status: Recruiting

Contact:
Last name: Cesar Augusto Perez Batista, MD

Start date: August 8, 2024

Completion date: December 2026

Lead sponsor:
Agency: Theravectys S.A.
Agency class: Industry

Source: Theravectys S.A.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06319963

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