Study on ProAgio and Gemcitabine for Patients with Metastatic Triple Negative Breast Cancer

Sponsor: ProDa BioTech, LLC

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06460298

Provider View

This clinical trial is testing a new treatment combining ProAgio and gemcitabine to see if it is safe and effective for patients with metastatic triple negative breast cancer who have already received other treatments.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new treatment combining ProAgio, a type of targeted therapy, with gemcitabine, a chemotherapy drug, in patients with metastatic triple negative breast cancer. This study is in its early phases and aims to find the best dose of ProAgio when used with gemcitabine.

Description

This study is designed to test the safety and effectiveness of combining ProAgio with gemcitabine in patients who have metastatic triple negative breast cancer and have already been treated with other therapies. The study will start with a small group of patients to determine the safest dose of ProAgio. The treatment will be given in increasing doses to find the best balance between effectiveness and side effects. The study will include up to 20 patients, and each group will receive a different dose level, starting from the lowest. Researchers will closely monitor patients for any side effects and how well the treatment works in shrinking the cancer.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with confirmed metastatic triple negative breast cancer.
  • Cancer must be negative for estrogen, progesterone, and HER2 receptors.
  • Must have received at least two previous treatments for advanced cancer.
  • Must be in good general health with a performance status of 0 to 2.
  • Must have adequate blood cell counts and organ function.
  • If cancer has spread to the brain, it must be stable and not worsening.
  • Must agree to provide a tumor sample and undergo a biopsy before and during treatment.
  • Women and men must agree to use effective birth control during the study and for six months after.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Previous treatment with gemcitabine for metastatic cancer.
  • Recent platelet transfusion within seven days before starting treatment.
  • History of heart disease or treatment with heart-damaging drugs unless heart function is stable.
  • Abnormal heart rhythm as shown on an EKG.
  • Chronic neurological disorders that could interfere with the study.
  • Pregnant or breastfeeding women.
  • Recent major surgery within 28 days before starting the study.
  • Recent uncontrolled bleeding episodes within 28 days before starting the study.

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