OncoMatch/Clinical Trials/NCT06460298
ProAgio in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer
Is NCT06460298 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including ProAgio Dose Levels (DL) 1,2,3,4 and ProAgio Dose Expansion for triple negative breast cancer.
Treatment: ProAgio Dose Levels (DL) 1,2,3,4 · ProAgio Dose Expansion — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 negative (less than 10%) (<10%)
estrogen receptor (ER) negative (less than 10%)
Required: PR (PGR) negative (less than 10%) (<10%)
progesterone receptor (PR) negative (less than 10%)
Required: HER2 (ERBB2) negative/unamplified as per ASCO/CAP guidelines (negative/unamplified)
HER2 negative/unamplified as per ASCO/CAP guidelines
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: gemcitabine (gemcitabine)
Exception: in the metastatic setting
Participants who have had prior treatment with gemcitabine in the metastatic setting.
Lab requirements
Blood counts
Absolute neutrophil count ≥1,500/mcL; Hemoglobin ≥9 g/dL (recent transfusion allowed); Platelets ≥100,000/mcL
Kidney function
Creatinine clearance ≥60 mL/min (measured using Cockcroft-Gault equation or the estimated glomerular filtration rate)
Liver function
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
Cardiac function
Patients with history of known congestive heart failure (LVEF <50%) must have documented LVEF >50% within 12 months of study enrollment; Prolonged QTc interval >480 msec on screening EKG [excluded]
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 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 Functional Classification. To be eligible for this trial, patients should be class 2B or better. Patients with history of known congestive heart failure (left ventricular ejection fraction (LVEF) <50%) must have documented LVEF >50% within 12 months of study enrollment. Prolonged QTc interval >480 msec on screening EKG [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Emory University Winship Cancer Institute · Atlanta, Georgia
- Winship Cancer Institute of Emory University · Atlanta, Georgia
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