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

Bayer12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasms

Interventions

BAY94-9343DRUG

Cohort 1: 4.5 mg/kg of BAY 94-9343 at Q3W dose regimen. Cohort 2: 6.5 mg/kg of BAY 94-9343 at Q3W dose regimen.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (2)

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

National Cancer Center Hospital

Tyuo, Japan

Outcomes

Primary Outcomes

Number of Treatment-emergent Adverse Events (TEAEs) as a measure of safety and tolerability

Time frame: Up to 9 weeks

Intensity of TEAEs acc. to NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v.4.03

Time frame: Up to 9 weeks

Cmax (maximum drug concentration in plasma after single dose administration ) for BAY94-9343, total antibody compound, DM4, metabolite DM4-Me