The purpose of this study is to identify the most appropriate dose that can be safely administered and that can have an effect on blood cancer cells. Once that safe dose is identified, additional patients will be asked to join the study to further evaluate the safety and effectiveness of the study drug. The study will also investigate the pharmacokinetics (study of what the body does to the drug), as well as pharmacodynamics (study of what the drug does to the body), which may provide information about the effects of BAY 1251152. The study will also measure some biological markers (markers of biological activity in your body) that can be used to predict the response and safety of the proposed treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Weekly infusion of BAY1251152 in 21-day cycles.
Unnamed facility
New York, New York, United States
Unnamed facility
The Bronx, New York, United States
Unnamed facility
Nashville, Tennessee, United States
Unnamed facility
Dresden, Saxony, Germany
Unnamed facility
Madrid, Spain
Unnamed facility
Cardiff, United Kingdom
Maximum tolerated dose(MTD)
To determine the MTD of BAY1251152 in subjects with advanced hematological neoplasms
Time frame: 21 days
Recommended Phase 2 dose (RP2D)
To determine the RP2D of BAY1251152 based on safety, tolerability, pharmacokinetic, and pharmacodynamic data in subjects with advanced hematological neoplasms
Time frame: Up to 30 months
Number of adverse events (AE)
For assessment of the safety (ECG, vital signs, clinical significant abnormal laboratory results… etc.)and tolerability of BAY 1251152 in subjects with advanced hematological neoplasms
Time frame: Up to 30 months
Pharmacokinetics (PK) is determined by maximum concentration (Cmax)
Time frame: 21 days
Pharmacokinetics (PK) is determined by Area Under concentration versus time Curve (AUC)
Time frame: 21 days
Response assessment of BAY 1251152 in hematological malignancies based on the internationally accepted criteria for the specific hematological malignancy which patient is suffering from
To assess the clinical efficacy of BAY 1251152 in subjects with advanced hematological neoplasms
Time frame: Up to 30 months
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