HPV Positive Oropharyngeal Squamous Cell Carcinoma, HPV-Related Cervical Carcinoma
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
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.
Detailed description
As of 06Nov2025 the recruitment in ARm A of the study (recurrent/metastatic cancers) has been closed to further enrollment, in accordance with the protocol and the study's prespecified operational and/or scientific considerations. No new participants will be enrolled into Arm A, and no additional study drug will be administered within this arm.
Interventions
DRUGTwo IM injections Lenti-HPV-07
two Lenti-HPV-07 intramuscular injections one month apart
DRUGOne IM injection Lenti-HPV-07
a single intramuscular injection prior to receiving a standard of care 28 days at least after the injection.
Sponsors
Theravectys S.A.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | 12 months after last injection | Frequency, intensity, and relationship of adverse events with vaccine administration per CTCAE v5.0 |
| OBD | 28 days after last injection | To identify the optimal biological dose (OBD) and schedule for subsequent trials of Lenti-HPV-07 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity | 12 months after last injection | * measure of CD4+ and CD8+ T cell responses specific to E6 or E7 from HPV16 and HPV18 in PBMC * repertoire and clonotype tracking, and cytometric analysis of T cell activation/effector/memory marker |
| PD-L1 expression | 12 months after last injection | PD-L1 tumor expression, as measured by composite positive score, by 50% both pre- and post-injection |
Countries
United States
Contacts
CONTACTDaniel Loera
Outcome results
None listed