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ProAgio in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer

Trying ProAgio and gemcitabine for advanced triple-negative breast cancer.

Recruiting
18 years and older
All
Phase 1/2

This study is testing a new drug combination for people with a kind of breast cancer called Metastatic Triple Negative Breast Cancer. The study is in two parts: Phase I and Phase II. It's checking if the new drug, ProAgio, is safe and works well when used with another drug called gemcitabine. ProAgio is an *anti-αvβ3 Integrin Cytotoxin*, which means it targets specific cells to kill cancer.

The study uses a method called *dose escalation*, which means they start with a low dose and slowly increase it to find the safest amount. Only 20 people will join at first. To be in the study, you must have tried other treatments and be 18 or older. You also need to have certain health conditions checked, like blood and organ health.

  • The study is for people who have tried other treatments.
  • Participants must be willing to undergo tumor biopsies.
  • Requires using contraception during and after the study.

People who have had gemcitabine before or have certain health issues, like heart problems, cannot join. Pregnant or nursing women are also excluded to avoid risks to babies.

Study details
    Triple Negative Breast Cancer

NCT06460298

ProDa BioTech, LLC

13 December 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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