Phase I Dose Escalation Study of BAY94-9343 Given by Intravenous Infusion Every 3 Weeks in Japanese Subjects With Advanced Malignancies

• Status: Completed
• Trial end date: 2017-07-04
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Immunoconjugates; Maytansine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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