Clinical Trial 23229

• Overview

  Study 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

  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). 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

  Objective:

  Primary Objectives: * To evaluate the safety and tolerability of Lenti-HPV-07 when administered to participants with advanced or metastatic HPV16/18-related oropharynx or cervical cancers * To identify the optimal biological dose (OBD) and schedule for subsequent trials of Lenti-HPV-07 Secondary Objectives: * To characterize the immunogenicity of Lenti-HPV-07 therapeutic vaccination in participants with HPV-associated oropharynx or cervical cancer at various dose levels * To evaluate the increase of PD-L1 expression by the tumors after Lenti-HPV-07 vaccination

• Treatments

  Therapies:

  Vaccine

  Medications:

  Lenti-HPV-07 ()

• Inclusion Criteria

  Inclusion Criteria:
  • Adults aged 18 years or older
  • histologically confirmed invasive HPV-related oropharyngeal or cervical cancer.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate hepatic, renal, pulmonary, and bone marrow/hematological function.
  • Males and females of childbearing potential must agree to use a highly effective method of contraception during treatment and for at least 12 months after the last dose of study treatment.
  • The capability to understand and comply with the protocol, and willingness to provide written informed consent for trial participation.
  • Other criteria may be applicable.

• Exclusion Criteria

  Exclusion Criteria:
  • Participants with seropositivity for HIV, active hepatitis C virus (HCV) infection, or hepatitis B (HBV) infection are not eligible.
  • Uncontrolled recurrent illness.
  • Underlying medical condition(s) for which, in the Investigator’s opinion, participation would not be in the best interest of the participant (eg, compromises the health of the participant) or that could prevent, limit, or confound protocol assessments.
  • Receipt of any live vaccines within 30 days prior to enrollment. NOTE: Previous treatment with flu vaccination is not an exclusion criterion.
  • Any history of exposure to cancer vaccines.
  • History of Guillain-Barré syndrome.
  • Pregnant or nursing (breastfeeding) women, or women who plan to be pregnant within 1 year after the last injection are excluded from this trial because there is an unknown but potential risk to LV vaccine.
  • Other criteria may be applicable

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