First in Human Dose Escalation Study of Vactosertib (TEW-7197) in Subjects With Advanced Stage Solid Tumors

Inclusion Criteria: * Advanced stage solid tumors as documented by histological or cytological evidence, with no available approved therapies known to cure metastatic disease or extend survival, and who have received all standard therapy. * Documented disease progression following prior therapy, as assessed by the Investigator. * Eastern Cooperative Oncology Group (ECOG) 0 or 1. * Evaluable or measurable disease as defined by RECIST v1.1 may be enrolled in the dose escalation part; for the dose confirmation part, subjects must have measurable disease by RECIST v1.1 or biomarker for response. * Males and females ≥ 18 years of age. * Able to give written informed consent. * Able to swallow tablets. * Willing and able to comply with scheduled visits, treatment plans, laboratory tests and procedures. * Acceptable liver function: * Bilirubin ≤ 1.5 times the upper limit of normal (ULN), * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the ULN; if liver metastases are present, then ≤ 5 times the ULN is allowed. * Acceptable renal function: \*Serum creatinine ≤ 1.5 times the ULN. * Acceptable hematologic status (without growth factor support or transfusion dependency): * Absolute neutrophil count (ANC) ≥ 1,500 cells/μL, * Platelet count ≥ 100,000/μL, * Hemoglobin ≥ 9.0 g/dL. * QTc interval calculated according to Fridericia's formula (QTcF = QT/RR0.33; RR = RR interval) of ≤ 450 msec on screening electrocardiogram (ECG). * Must have a no…