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

Theravectys

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: HPV-Related Cervical Carcinoma; HPV Positive Oropharyngeal Squamous Cell Carcinoma

Treatments: Drug: Two IM injections Lenti-HPV-07; Drug: One IM injection Lenti-HPV-07

Study type: Interventional

Funder types: Industry

Identifiers

NCT06319963

Lenti-HPV-07-CT01

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Arm A : Refractory newly diagnosed

Experimental group

Description:

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).

Treatment:

Drug: Two IM injections Lenti-HPV-07

Arm B : newly diagnosed locally advanced

Experimental group

Description:

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).

Treatment:

Drug: One IM injection Lenti-HPV-07