Study on TLPO Cancer Vaccine for Solid Tumors

Sponsor: Elios Therapeutics, LLC

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06175221

Provider View

This clinical trial is exploring the TLPO cancer vaccine to see if it can help control various solid tumors. The study aims to understand how long it takes for the cancer to progress after vaccination, the overall survival of patients, the safety of the vaccine, and whether it triggers an immune response.

Patient Parameters

Program Overview

The purpose of this study is to learn about the TLPO cancer vaccine in patients with solid tumors. Researchers want to find out how long it takes for the cancer to progress or come back after vaccination, how long patients survive, and if the vaccine is safe. They also want to see if the vaccine can trigger an immune response and how well it controls the disease.

Description

Patients with any stage of solid tumor cancer will be considered for this study. Eligible patients will have a sample of their tumor taken through surgery or a needle biopsy. This sample will be sent to a lab to create the TLPO vaccine. If patients need treatments like chemotherapy or radiation, they will receive the vaccine after these treatments are completed. Patients on certain maintenance therapies can start the vaccine trial after showing they can tolerate these therapies for three months.

The vaccine will be given in six doses over a year, with the first three doses given monthly and the last three doses given every three months. The injections will be given in the same area, usually the front of the thigh. Researchers will collect safety data and monitor the time it takes for the cancer to progress or come back. Patients will be followed by their treatment team every six months for two years. If the cancer returns, it will be confirmed with a biopsy. Blood samples will be collected before each vaccine dose to study the immune response.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have any stage of solid tumor cancer.
  • Have tolerated maintenance or adjuvant therapies for three doses if needed.
  • Be in good overall health with a performance status of 0 or 1.
  • Have a life expectancy of at least 6 months.
  • No uncontrolled or life-threatening health conditions.
  • No active infections.
  • Meet specific blood test requirements.
  • Completed standard treatments like chemotherapy or radiation if needed.
  • Agree to use birth control during the study and for 90 days after the last vaccine dose.
  • Have a tumor that can be biopsied to create the vaccine.

Exclusion Criteria

  • Use of steroids, immunosuppressive therapy, or chemotherapy within 30 days before joining the study.
  • Participation in other clinical trials.
  • Poor overall health with a performance status of 2 or higher.
  • Pregnant or breastfeeding.
  • Untreated or worsening brain metastases.
  • Rapidly progressing disease or severe symptoms.
  • History of organ or stem-cell transplantation.
  • Diagnosis of immunodeficiency.
  • Current second cancer, except for certain skin or cervical cancers.
  • Active infections like Hepatitis or HIV.
  • Received live vaccines within 30 days before the study.
  • Serious heart conditions or events within 6 months before the study.
  • Any condition that might increase risk or affect study participation.

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