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

Part of paid clinical trials in Orlando, Florida.

Sponsor
Theravectys S.A.
Study ID
NCT06319963
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • HPV Positive Oropharyngeal Squamous Cell Carcinoma
  • HPV-Related Cervical Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Two IM injections Lenti-HPV-07 — DRUG
    two Lenti-HPV-07 intramuscular injections one month apart
  • 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.

Study Details

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.

Key Dates

Start date
Aug 8, 2024
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
72 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A : Refractory newly diagnosed
    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).
  • Experimental: Arm B : newly diagnosed locally advanced
    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).

Primary Outcome Measure

Safety and Tolerability [ Time Frame: 12 months after last injection ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Florida Cancer Specialists (from Sarah Canon research Institute)OrlandoFlorida32827
Cesar Augusto Perez Batista, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Guilherme Rabinowits, MD (PRINCIPAL_INVESTIGATOR)
Tampa General HospitalTampaFlorida33606
Noman Ashraf, MD (PRINCIPAL_INVESTIGATOR)
Oklahoma Cancer Specialists and Research Institute, LLCTulsaOklahoma74146
Daron Street, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Orlando, FL

By research site
Florida Cancer Specialists (from Sarah Canon research Institute)· Orlando, FLMoffitt Cancer Center· Tampa, FLTampa General Hospital· Tampa, FLOklahoma Cancer Specialists and Research Institute, LLC· Tulsa, OK

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