ProAgio in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer
- Conditions
- Triple Negative Breast Cancer
- Registration Number
- NCT06460298
- Lead Sponsor
- ProDa BioTech, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Adult participants, = 18 years of age, with histologically or cytologically<br> confirmed metastatic breast cancer that is estrogen receptor (ER) negative (less<br> than 10%), progesterone receptor (PR) negative (less than 10%), and HER2<br> negative/unamplified as per ASCO/CAP guidelines (Wolff et al., 2018). If ER/PR less<br> than 10%, prior endocrine therapy is permitted, and the participant is not<br> considered appropriate for hormone based therapy. Participants must agree to provide<br> archival tumor material from metastatic site (most recent archival tumor tissue<br> immediately prior to enrollment is strongly preferred) and must agree to undergo<br> research tumor biopsy before treatment and during cycle 2 at the same site of<br> metastatic disease, if presence of easily accessible lesion, at the discretion of<br> the treating physician.<br><br> - Participants must have received at least two lines of prior systemic treatment for<br> advanced disease. If participants received systemic therapy in the operable setting<br> and the tumor progressed within 12 months of the receipt of the last dose of<br> systemic therapy, this will be considered one line of prior systemic therapy for<br> advance disease. Participants must be more than 14 days removed from most recent<br> standard of care or experimental drug treatment for their tumor.<br><br> - ECOG performance status =2<br><br> - Participants must have adequate organ and marrow function as defined below:<br><br> - Absolute neutrophil count =1,500/mcL<br><br> - Hemoglobin =9 g/ dL (recent transfusion allowed)<br><br> - Platelets =100,000/mcL<br><br> - AST(SGOT)/ALT(SGPT) =3 x ULN. AST and ALT (up to 5x ULN is permitted for<br> participants with liver metastases)<br><br> - Total bilirubin =1.5 x institutional ULN<br><br> - Creatinine clearance =60 mL/min (measured using Cockcroft- Gault equation or the<br> estimated glomerular filtration rate)<br><br> - Participants with CNS metastases must be treated and/or stable (no progression for<br> at least 4 weeks after local prior therapy as ascertained by clinical examination<br> and brain imaging (MRI or CT) during the screening period). Those with symptoms<br> suggestive of possible CNS metastases (such as new headaches) must undergo brain MRI<br> as part of screening.<br><br> - Patients with a prior or concurrent malignancy whose natural history or treatment<br> does not have the potential to interfere with the safety or efficacy assessment of<br> the investigational regimen are eligible for this trial.<br><br> - The effects of ProAgio on the developing human fetus are unknown. For this reason,<br> women of child-bearing potential and men must agree to use adequate contraception<br> (hormonal or barrier method of birth control; abstinence) prior to study entry, for<br> the duration of study participation and for the 6 months following the last dosing<br> of study drug. Should a woman become pregnant or suspect she is pregnant while she<br> or her partner is participating in this study, she should inform her treating<br> physician immediately.<br><br> - During dose escalation, participants with bone only and/or non-measurable disease<br> are eligible. During dose expansion, only participants with measurable disease are<br> eligible.<br><br> - Ability of subject to understand and the willingness to sign a written informed<br> consent document.<br><br>Exclusion Criteria:<br><br> - Participants who have had prior treatment with gemcitabine in the metastatic<br> setting.<br><br> - Platelet transfusion within 7 days prior to treatment start.<br><br> - Participants with known history or current symptoms of cardiac disease, or history<br> of treatment with cardiotoxic agents, should have a clinical risk assessment of<br> cardiac function using the New York Heart Association Functional Classification. To<br> be eligible for this trial, patients should be class 2B or better. Patients with<br> history of known congestive heart failure (left ventricular ejection fraction (LVEF)<br> <50%) must have documented LVEF >50% within 12 months of study enrollment.<br><br> - Prolonged QTc interval >480 msec on screening EKG<br><br> - Participants with known diagnosis of a chronic neurologic disorders (such as<br> multiple sclerosis, Huntington's disease, Parkinson's disease, or uncontrolled<br> epilepsy) which causes motor disturbance, visual disturbance, or seizure and could<br> confound assessment of neurologic toxicity caused by the study drug.<br><br> - Pregnant or nursing women are excluded from this study because ProAgio is an agent<br> with the potential for teratogenic or abortifacient effects. Because there is an<br> unknown but potential risk for adverse events in nursing infants secondary to<br> treatment of the mother with ProAgio, breastfeeding should be discontinued if the<br> mother is treated with ProAgio.<br><br> - Participants who have undergone a major surgical procedure (within < 28 days) are<br> excluded.<br><br> - Participants with uncontrolled bleeding episodes <28 days prior to enrollment are<br> excluded.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part 1 (Dose Escalation);Part 2 (Dose Expansion)
- Secondary Outcome Measures
Name Time Method Clinical Benefit Rate;Estimate the mean change from baseline in tumor stromal collagen;Progression free survival (PFS)