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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