To assess safety and tolerability, describe the dose-limiting toxicities, assess the preliminary antitumor activity, 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 advanced or metastatic solid tumor malignancies that have received at least 1 prior line of treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Subjects with advanced solid tumors will enroll into the respective arms to receive Medi7247 IV at prescribed dose and schedule
Research Site
Huntersville, North Carolina, United States
Research Site
Nashville, Tennessee, United States
Research Site
Toronto, Ontario, Canada
Occurrence of Adverse Events
To assess the occurrence of adverse events
Time frame: From time of informed consent through 90 days post end of treatment
Occurrence of Serious Adverse Events
To assess the occurrence of serious adverse events
Time frame: From time of informed consent through 90 days post end of treatment
Occurrence of Dose Limiting Toxicities
To assess the occurrence of toxicities and abnormal laboratory results that may limit further dose administration
Time frame: During the evaluation period of 21 days post first dose
Number of patients with changes in laboratory parameters from baseline
To assess serum chemistry, hematology, urinalysis and coagulation parameters
Time frame: From time of informed consent through 90 days post end of treatment
Number of patients with changes in vital signs parameters from baseline
to assess changes in vital signs
Time frame: from time of informed consent through 21 days post last dose
Number of patients with changes in electrocardiogram results from baseline
to assess changes in ECG
Time frame: from time of informed consent through 21 days post last dose
Percentage of patients with changes in laboratory parameters from baseline
to assess changes in serum chemistry, hematology, urinalysis, and coagulation parameters
Time frame: from time of informed consent through 90 days post end of treatment
MEDI7247 maximum observed concentration (Cmax)
To characterize MEDI7247 single agent Pharmacokinetics
Time frame: From first dose through 90 days post end of treatment
MEDI7247 terminal half life (t1/2)
To characterize single agent MEDI7247 pharmacokinetics
Time frame: From first dose through 90 days post end of treatment
MEDI7247 area under the concentration/time curve (AUC)
To characterize single agent MEDI7247 pharmacokinetics
Time frame: from first dose through 90 days post end of treatment
MEDI7247 clearance
to characterize the single agent MEDI7247 pharmacokinetics
Time frame: from first dose through 90 days post end of treatment
Number of subjects who develop anti-drug antibodies
To characterize MEDI7247 immunogenicity
Time frame: first dose through 90 days post end of treatment
Best Overall Response
To assess antitumor activity of MEDI7247
Time frame: From time of informed consent and up to 90 days post end of treatment
Objective Response Rate (ORR)
To assess antitumor activity of MEDI7247
Time frame: From time of informed consent and up to 2 years after last subject in
Time to Response (TTR)
To assess antitumor activity of MEDI7247
Time frame: From time of informed consent and up to 90 days post end of treatment
Duration of Response (DoR)
To assess antitumor activity of MEDI7247
Time frame: From time of informed consent and up to 2 years after last subject in
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Progression Free Survival (PFS)
To assess the antitumor activity of MEDI7247
Time frame: From time of informed consent and up to 2 years after last subject in
Disease Control (DC)
To assess antitumor activity of MEDI7247
Time frame: From time of informed consent and up to 2 years after last subject in
Overall Survival (OS)
To assess antitumor activity of MEDI7247
Time frame: From time of informed consent and up to 2 years after last subject in