TR-002 for the Treatment of Advanced Unresectable Metastatic Solid Tumors Unresectable or Metastatic, Refractory Pancreatic Adenocarcinoma

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD), which will also be the recommended phase 2 dose (RP2D) of Nadofaragene Firadenovec (TR-002) for the treatment of advanced treatment-refractory solid tumors. II. To evaluate the toxicities of TR-002 administered intravenous weekly. SECONDARY OBJECTIVES: I. To obtain preliminary assessment of anti-tumor activity of TR-002 administered intravenous weekly at the RP2D. II. To evaluate the pharmacokinetics of TR-002 administered intravenous weekly. EXPLORATORY OBJECTIVE: I. To assess the effects of TR-002 on pharmacodynamic biomarkers relating to the mechanism of action. OUTLINE: This is a dose-escalation study of TR-002 followed by a dose-expansion study. Patients receive TR-002 intravenously (IV), over 1 hour, on days 1, 8, 15 and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography or multigated acquisition (MUGA) scan during screening and undergo computed tomography (CT) scan, magnetic resonance imaging (MRI), tumor biopsy and blood sample collection throughout the study. After completion of study treatment, patients are followed up at 30 days and every 60 days for 1 year.