Actively Recruiting
ProAgio in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer
Led by ProDa BioTech, LLC · Updated on 2025-08-12
51
Participants Needed
2
Research Sites
110 weeks
Total Duration
On this page
Sponsors
P
ProDa BioTech, LLC
Lead Sponsor
E
Emory University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
ProAgio in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with metastatic breast cancer confirmed to be estrogen receptor negative (<10%), progesterone receptor negative (<10%), and HER2 negative/unamplified
- Participants must have received at least two prior systemic treatments for advanced disease or have had tumor progression within 12 months after adjuvant therapy
- ECOG performance status of 2 or less
- Adequate organ and marrow function as defined by specific blood counts and liver/kidney function tests
- Treated and stable central nervous system metastases with no progression for at least 4 weeks
- Ability to provide archival tumor tissue and agree to tumor biopsies before treatment and during cycle 2 if accessible
- Use of adequate contraception for men and women of childbearing potential during and for 6 months after study participation
- During dose escalation, participants with bone-only or non-measurable disease are eligible; during dose expansion, only participants with measurable disease
- Ability to understand and provide written informed consent
You will not qualify if you...
- Prior treatment with gemcitabine in the metastatic setting
- Platelet transfusion within 7 days before treatment start
- History or symptoms of cardiac disease with New York Heart Association Functional Classification worse than 2B
- Known congestive heart failure with left ventricular ejection fraction below 50% unless recent tests show LVEF above 50%
- Prolonged QTc interval greater than 480 msec on screening EKG
- Diagnosis of chronic neurological disorders causing motor, visual, or seizure disturbances
- Pregnant or nursing women
- Major surgery within 28 days before enrollment
- Uncontrolled bleeding episodes within 28 days prior to enrollment
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
Research Team
D
Damon Michaels
CONTACT
Z
Zhi-Ren Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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