Phase I dose escalation study of BAY94-9343 given by intravenous infusion every 3 weeks in Japanese subjects with advanced malignancies
The primary objectives of the Phase I study 15404 are to evaluate the safety, tolerability and pharmacokinetics of BAY94-9343 given once every 3 weeks in Japanese subjects with advanced, refractory solid tumors.
The secondary objectives are to investigate the efficacy, biomarkers and immunogenicity.
- Japanese subjects ≥ 20 years of age - ECOG Performance Status of 0 to 1 - Life expectancy of at least 12 weeks - Subjects with advanced, histologically or cytologically confirmed solid tumors, not amenable to any standard therapy, have no standard therapy available - Subjects whose fresh or archival tumor tissues are available - Measurable disease with at least one lesion that can be accurately measured in at least one dimension according to RECIST criteria (Version 1.1 or modified version) - Adequate bone marrow, liver, and renal function
- Anticancer chemotherapy, experimental cancer therapy, or immunotherapy within 2 weeks of start of the first dose - Impaired cardiac function or clinically significant cardiac disease (i.e., congestive heart failure (CHF) NYHA Class III or IV) - Myocardial infarction or onset of unstable angina < 3 months prior to general screening - Cardiac arrhythmias in the electrocardiogram that would interfere with QT/QTc interval measurement (LBBB (left bundle branch block), AV block, atrial fibrillation) - QTc >470 ms, derived as the average of the 3 values measured by the ECG recorder’s algorithm on the ECG triplicate - LVEF (left ventricular ejection fraction) <50 % - Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 90 mmHg, despite optimal medical management - Known human immunodeficiency virus (HIV) infection - Subjects with an active hepatitis B or C infection requiring treatment - Personal or family history of Long QT Syndrome (LQTS) - Subject with clinically significant eye disorders
An open label, Phase I study to evaluate the safety, tolerability and pharmacokinetics of BAY94-9343 given by intravenous infusion every 3 weeks (Q3W) in Japanese subjects with advanced malignancies
Single Group Assignment