To assess safety and tolerability, describe the dose-limiting toxicities, determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (maximum administered dose) in the absence of establishing the MTD, and a recommended dose for further evaluation of MEDI7247 in patients with selected hematological malignancies who have relapsed after, or are refractory to prior standard therapy, and for whom there is no standard salvage regimen available.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
67
The study will enroll patients with R/R AML/MM/DLBCL who will receive MEDI7247 IV
Research Site
Los Angeles, California, United States
Research Site
Denver, Colorado, United States
Research Site
Atlanta, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Boston, Massachusetts, United States
Research Site
St Louis, Missouri, United States
Research Site
New York, New York, United States
Research Site
Greer, South Carolina, United States
Research Site
Nashville, Tennessee, United States
Research Site
San Antonio, Texas, United States
...and 4 more locations
Occurrence of adverse events (AEs)
To assess by the occurrence of adverse events (AEs)
Time frame: From time of informed consent through 90 days post end of treatment
Occurrence of serious adverse events (SAEs)
To assess by the occurrence of serious adverse events (SAEs)
Time frame: From time of informed consent through 90 days post end of treatment
Occurrence of dose-limiting toxicities (DLTs)
To assess by the occurrence of non-Hematologic and hematologic toxicities, AEs, and abnormal laboratory results.
Time frame: During the evaluation period of 21 or 42 days post-first dose
Number of patients with changes in laboratory parameters from baseline
To assess serum chemistry, hematology, Coagulation and urinalysis
Time frame: From time of informed consent and up to 21 days post end of treatment
Number of patients with changes in vital signs from baseline
To assess body temperature, blood pressure, and heart rate
Time frame: From time of informed consent and up to 21 days post end of treatment
Number of patients with changes in electrocardiogram (ECG) results from baseline
To assess using twelve-lead ECG recordings
Time frame: From time of informed consent and up to 21 days post end of treatment
Percentage of patients with changes in laboratory parameters from baseline
To assess serum chemistry, hematology, Coagulation and urinalysis
Time frame: From time of informed consent and up to 21 days post end of treatment
MEDI7247 maximum observed concentration for PK
To assess the Pharmacokinetics of MEDI7247
Time frame: From time of informed consent through 30 days post end of treatment
MEDI7247 area under the concentration-time curve for PK
To assess the Pharmacokinetics of MEDI7247
Time frame: From time of informed consent through 30 days post end of treatment
MEDI7247 clearance for PK
To assess the Pharmacokinetics of MEDI7247
Time frame: From time of informed consent through 30 days post end of treatment
MEDI7247 terminal half-life for PK
To assess the Pharmacokinetics of MEDI7247
Time frame: From time of informed consent through 30 days post end of treatment
Number of subjects who develop anti-drug antibodies (ADAs)
To assess the immunogenicity of MEDI7247
Time frame: From time of informed consent through 30 days post end of treatment
Best overall response (BOR)
To assess the anti-tumor activity of MEDI7247
Time frame: From time of informed consent and up to 3 years after final patient is enrolled
Objective response rate (ORR)
To assess the anti-tumor activity of MEDI7247
Time frame: From time of informed consent and up to 3 years after final patient is enrolled
Time to response (TTR)
To assess the anti-tumor activity of MEDI7247
Time frame: From time of informed consent and up to 3 years after final patient is enrolled
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Duration of response (DoR)
To assess the anti-tumor activity of MEDI7247
Time frame: From time of informed consent and up to 3 years after final patient is enrolled
Progression-free survival (PFS)
To assess the anti-tumor activity of MEDI7247
Time frame: From time of informed consent and up to 3 years after final patient is enrolled
Overall survival (OS)
To assess the anti-tumor activity of MEDI7247
Time frame: From time of informed consent and up to 3 years after final patient is enrolled