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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:
Participants will be assigned to a group based on their cancer type
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Two IM injections Lenti-HPV-07 | Drug | two Lenti-HPV-07 intramuscular injections one month apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Frequency, intensity, and relationship of adverse events with vaccine administration per CTCAE v5.0 | 12 months after last injection |
| OBD | To identify the optimal biological dose (OBD) and schedule for subsequent trials of Lenti-HPV-07 | 28 days after last injection |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity |
| 12 months after last injection |
| PD-L1 expression |
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Inclusion Criteria:
Exclusion Criteria:
- with seropositivity for HIV, active hepatitis C virus (HCV) infection, or hepatitis B (HBV) infection
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Loera | Contact | 713-256-8202 | dloera@oncobay.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Cancer Specialists (from Sarah Canon research Institute) | Recruiting | Orlando | Florida | 32827 | United States |
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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.
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| One IM injection Lenti-HPV-07 | Drug | a single intramuscular injection prior to receiving a standard of care 28 days at least after the injection. |
|
PD-L1 tumor expression, as measured by composite positive score, by 50% both pre- and post-injection |
| 12 months after last injection |
| Tampa General Hospital | Recruiting | Tampa | Florida | 33606 | United States |
|
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
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| Oklahoma Cancer Specialists and Research Institute, LLC | Recruiting | Tulsa | Oklahoma | 74146 | United States |
|
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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