HPV-Related Cervical CarcinomaPhase 1/2NCT06319963
A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer
A Phase 1/2 study testing Two IM injections Lenti-HPV-07 and One IM injection Lenti-HPV-07 in people with HPV-Related Cervical Carcinoma and HPV Positive Oropharyngeal Squamous Cell Carcinoma, run by Theravectys S.A. at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HPV-Related Cervical Carcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma
- What is being tested?
- Two IM injections Lenti-HPV-07 and One IM injection Lenti-HPV-07
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Aug 2024to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- with seropositivity for HIV, active hepatitis C virus (HCV) infection, or hepatitis B (HBV) infection
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Florida Cancer Specialists (from Sarah Canon research Institute)
Orlando, Florida, 32827
Cesar Augusto Perez Batista, MD
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
Noman Ashraf, MD
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Guilherme Rabinowits, MD
- Recruiting
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, 74146
Daron Street, MD
About this study
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
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:
Read more
- 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.
Read the 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.
- Being tested
- Two IM injections Lenti-HPV-07, One IM injection Lenti-HPV-07
- 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
- Medical subject headings
- Uterine Cervical Neoplasms, Oropharyngeal Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two IM injections Lenti-HPV-07Drug
two Lenti-HPV-07 intramuscular injections one month apart
One IM injection Lenti-HPV-07Drug
a single intramuscular injection prior to receiving a standard of care 28 days at least after the injection.
| Study group | Role | What they receive |
|---|---|---|
| Arm A : Refractory newly diagnosed | Experimental | 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). Receives: Drug: Two IM injections Lenti-HPV-07 |
| Arm B : newly diagnosed locally advanced | Experimental | 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). Receives: Drug: One IM injection Lenti-HPV-07 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Frequency, intensity, and relationship of adverse events with vaccine administration per CTCAE v5.0
Measured: 12 months after last injection
OBD
To identify the optimal biological dose (OBD) and schedule for subsequent trials of Lenti-HPV-07
Measured: 28 days after last injection
Secondary outcomes (2)
Immunogenicity
- 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
Measured: 12 months after last injection
PD-L1 expression
PD-L1 tumor expression, as measured by composite positive score, by 50% both pre- and post-injection
Measured: 12 months after last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start8 Aug 2024
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV-Related Cervical CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theravectys S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319963
- Sponsor's protocol ID
- Lenti-HPV-07-CT01
- Status last verified
- Jan 2026
- First submitted
- 27 Feb 2024
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06319963
- Acronym / sponsor ID
- Lenti-HPV-07-CT01
- Keywords
- HPV16, Cervical Cancer, Oropharyngeal cancer, Immuno-oncotherapy, Head and Neck Cancers, T-cell vaccine, Lentiviral Vector, Anti-tumor immunity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Theravectys S.A.Industry (pharma, biotech, devices)
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm A : Refractory newly diagnosed | Experimental | Drug: Two IM injections Lenti-HPV-07Refractory 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). |
| Arm B : newly diagnosed locally advanced | Experimental | Drug: One IM injection Lenti-HPV-07Participants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- with seropositivity for HIV, active hepatitis C virus (HCV) infection, or hepatitis B (HBV) infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Two IM injections Lenti-HPV-07two Lenti-HPV-07 intramuscular injections one month apart | Drug | Arm A : Refractory newly diagnosed |
| One IM injection Lenti-HPV-07a single intramuscular injection prior to receiving a standard of care 28 days at least after the injection. | Drug | Arm B : newly diagnosed locally advanced |
Primary outcome
Safety and Tolerability
Time frame: 12 months after last injection
Frequency, intensity, and relationship of adverse events with vaccine administration per CTCAE v5.0
OBD
Time frame: 28 days after last injection
To identify the optimal biological dose (OBD) and schedule for subsequent trials of Lenti-HPV-07
2 secondary outcomes
Immunogenicity
Time frame: 12 months after last injection
PD-L1 expression
Time frame: 12 months after last injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Two IM injections Lenti-HPV-07 and One IM injection Lenti-HPV-07 in people with HPV-Related Cervical Carcinoma and HPV Positive Oropharyngeal Squamous Cell Carcinoma, run by Theravectys S.A. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Loera (713-256-8202, dloera@oncobay.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: 12 months after last injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.