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New treatment option for Triple Negative Breast Cancer
Official title ProAgio in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer
ClinicalTrials.gov ID: NCT06460298
What this study is testing
What is ProAgio Dose Levels (DL) 1,2,3,4?
ProAgio Dose Levels (DL) 1,2,3,4 is an investigational medicine, being studied as a potential treatment for triple negative breast cancer.
Also referred to as ACT50, Gemcitabine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult participants, ≥ 18 years of age, with histologically or cytologically confirmed metastatic breast cancer that is estrogen receptor (ER)...
- Participants must have received at least two lines of prior systemic treatment for advanced disease. If participants received systemic therapy in the...
- ECOG performance status ≤2
- Participants must have adequate organ and marrow function as defined below:
- Absolute neutrophil count ≥1,500/mcL
You likely can't join if
- Participants who have had prior treatment with gemcitabine in the metastatic setting.
- Platelet transfusion within 7 days prior to treatment start.
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk...
- Prolonged QTc interval \>480 msec on screening EKG
- Participants with known diagnosis of a chronic neurologic disorders (such as multiple sclerosis, Huntington's disease, Parkinson's disease, or...
- Pregnant or nursing women are excluded from this study because ProAgio is an agent with the potential for teratogenic or abortifacient effects...
See the full eligibility 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...
- Participants must have received at least two lines of prior systemic treatment for advanced disease. If participants received systemic therapy in the operable setting and the tumor progressed within 12 months of the...
- ECOG performance status ≤2
- Participants must have adequate organ and marrow function as defined below:
- Absolute neutrophil count ≥1,500/mcL
- Hemoglobin ≥9 g/ dL (recent transfusion allowed)
- Platelets ≥100,000/mcL
- AST(SGOT)/ALT(SGPT) ≤3 x ULN. AST and ALT (up to 5x ULN is permitted for participants with liver metastases)
- Total bilirubin ≤1.5 x institutional ULN
- Creatinine clearance ≥60 mL/min (measured using Cockcroft- Gault equation or the estimated glomerular filtration rate)
- Participants with CNS metastases must be treated and/or stable (no progression for at least 4 weeks after local prior therapy as ascertained by clinical examination and brain imaging (MRI or CT) during the screening...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- The effects of ProAgio on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control...
- During dose escalation, participants with bone only and/or non-measurable disease are eligible. During dose expansion, only participants with measurable disease are eligible.
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Participants who have had prior treatment with gemcitabine in the metastatic setting.
- Platelet transfusion within 7 days prior to treatment start.
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- Prolonged QTc interval \>480 msec on screening EKG
- Participants with known diagnosis of a chronic neurologic disorders (such as multiple sclerosis, Huntington's disease, Parkinson's disease, or uncontrolled epilepsy) which causes motor disturbance, visual disturbance...
- Pregnant or nursing women are excluded from this study because ProAgio is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in...
- Participants who have undergone a major surgical procedure (within \< 28 days) are excluded.
- Participants with uncontrolled bleeding episodes \<28 days prior to enrollment are excluded.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.