ProAgio with Gemcitabine for Metastatic Triple Negative Breast Cancer

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

Recruiting Phase 1 Phase 2 Interventional Study
Triple Negative Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
51 (estimated)
Sponsor
ProDa BioTech, LLC · Industry
Who this trial is looking for

This trial is looking for adults with metastatic triple negative breast cancer. Participants will receive a new treatment called ProAgio along with an existing medication, gemcitabine.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have metastatic triple negative breast cancer.
  • I have received at least two prior treatments for my cancer.
  • I agree to provide tumor samples for research.
  • I have acceptable organ function.
  • I am stable if I have brain metastases.
  • I can understand and sign the informed consent.

You may not be able to join if

  • I have received gemcitabine for my metastatic cancer before.
  • I had a platelet transfusion in the last 7 days.
  • I have a current heart condition or symptoms.
  • I have a prolonged QTc interval on my recent EKG.
  • I have a chronic neurological disorder.
  • I am pregnant or nursing.
  • I had major surgery in the last 28 days.
  • I have had uncontrolled bleeding in the last 28 days.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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About This Trial

This is a Phase I/II Trial Evaluating the Safety and Efficacy of ProAgio, an anti- αvβ3 Integrin Cytotoxin, in Combination with Gemcitabine in Patients with Metastatic Triple Negative Breast Cancer

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Adult participants, ≥ 18 years of age, with histologically or cytologically confirmed metastatic breast cancer that is estrogen receptor (ER) negative (less than 10%), progesterone receptor (PR) negative (less than 10%), and HER2 negative/unamplified as per ASCO/CAP guidelines…
Contacts

Damon Michaels

615-614-1185

damon.michaels@medelis.com

CONTACT

Zhi-Ren Liu

zliu8@gsu.edu

CONTACT