Prime-boost Immunotherapy Trial for Men with Recurring Prostate Cancer After Local Treatment

Sponsor: Barinthus Biotherapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05617040

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This clinical trial is testing a new immunotherapy treatment, VTP-850, for men whose prostate cancer has returned after initial treatment. The study aims to evaluate the safety and effectiveness of this treatment in reducing prostate-specific antigen (PSA) levels.

Patient Parameters

Program Overview

This study is a Phase 1/2 trial conducted at multiple centers to test the safety and effectiveness of a new immunotherapy, VTP-850, in men whose prostate cancer has returned after local treatment. VTP-850 includes two components: ChAdOx1-PCAQ and MVA-PCAQ. Participants will receive ChAdOx1-PCAQ on Day 1 and MVA-PCAQ on Days 29 and 57. The study will follow participants for 6 months to monitor PSA levels and any side effects. If PSA levels drop by 50% or more, participants may be followed for an additional 18 months. The trial will help determine the best dose and method of administration for future studies.

Description

This clinical trial is designed to evaluate a new immunotherapy treatment, VTP-850, for men with prostate cancer that has returned after initial treatment. The trial is divided into two phases. In Phase 1, a small group of participants will receive the treatment to determine the best dose and method of administration. In Phase 2, more participants will be enrolled to further test the treatment's effectiveness.

VTP-850 consists of two parts: ChAdOx1-PCAQ and MVA-PCAQ. Participants will receive ChAdOx1-PCAQ on Day 1 and MVA-PCAQ on Days 29 and 57. The study will monitor participants for 6 months to see if their PSA levels decrease and to check for any side effects. If a participant's PSA levels drop by 50% or more, they may be followed for an additional 18 months.

The trial aims to find out if this new treatment can safely reduce PSA levels in men with recurring prostate cancer. Participants will be closely monitored throughout the study to ensure their safety and to gather data on the treatment's effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 years and older.
  • Confirmed diagnosis of prostate adenocarcinoma.
  • Have had primary treatment for prostate cancer, such as surgery or radiation.
  • No plans for further local or systemic prostate cancer treatment within 4 months of starting the trial.
  • Testosterone levels above 175 ng/dL.
  • No evidence of cancer spread or recurrence in the prostate area, confirmed by scans.
  • PSA levels above 0.3 ng/mL for those who had surgery, or 2 ng/mL above the lowest level for those who had radiation.
  • PSA doubling time of 12 months or less.
  • Not planning to start hormone therapy for at least 4 months after starting the trial.
  • Good overall health with an ECOG score of 0 or 1.
  • Meet specific blood and organ function criteria.
  • Agree to use contraception or abstain from sex during the trial and for 65 days after the last dose.
  • Willing to follow all trial procedures and attend scheduled visits.

Exclusion Criteria

  • Any other cancer within the past 5 years, except for certain skin cancers.
  • Unstable medical conditions or substance abuse that could affect safety or trial participation.
  • Significant heart, lung, kidney, digestive, blood, or nerve disorders.
  • Current or past liver disease, except for certain conditions.
  • Active autoimmune disease requiring treatment in the past 2 years.
  • Severe allergy to eggs or past severe reaction to vaccines.
  • Medical history that increases risk of vaccine reaction.
  • Immunocompromised state or history of organ transplant.
  • Active infection requiring antibiotics or fever within 7 days before starting the trial.
  • History of certain viral infections.
  • Recent radiation therapy or hormone therapy for prostate cancer.
  • Prior chemotherapy, immunotherapy, or participation in a prostate cancer trial.
  • Recent vaccination with adenovirus vector or live vaccines.
  • Recent use of immunoglobulins or blood products.
  • Use of systemic steroids or immunosuppressive medications recently.
  • Recent participation in another clinical trial.
  • Significant heart conditions or uncontrolled blood pressure or cholesterol.

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