To evaluate the safety and tolerability of MEDI0562 in adult subjects with selected advanced solid tumors
This is a first-time-in-human (FTiH) Phase 1, multicenter, open-label, dose-escalation, and dose-expansion study of MEDI0562 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and preliminary anti-tumor activity in adult subjects with selected advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Subjects will receive MEDI0562 until unacceptable toxicity, confirmed disease progression or other reason for treatment discontinuation develops.
Research Site
La Jolla, California, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Detroit, Michigan, United States
Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
The maximum tolerated dose/maximum administered dose will be determined by the number of participants experiencing DLTs. The safety profile will be assessed through number of participants experiencing AEs, SAEs, abnormal laboratory parameters, vital signs and electrocardiogram (ECG) results.
Time frame: From time of informed consent through 12 weeks after last dose of MEDI0562
Objective response rate (ORR)
The ORR is defined as the proportion of subjects with confirmed immune related (ir)CR or confirmed irPR
Time frame: Estimated to be from time of informed consent up to 5 years
Maximum observed concentration (Cmax), area under the curve (AUC), clearance (CL) and terminal half-life of MEDI0562
The endpoints for assessment of PK of MEDI0562 include MEDI0562 concentrations in serum at different timepoints after MEDI0562 administration.
Time frame: From first dose of MEDI0562 through to 30 days after last dose of investigational product
Number and percentage of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of MEDI0562 will be assessed by summarizing the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From first dose of MEDI0562 through to 30 days after last dose of investigational product
Induction of proliferation markers on various lymphocyte subsets, immunohistochemistry of tumor biopsies and assessment of programmed death ligand 1 (PD-L1) and tumor-infiltrating lymphocyte phenotypic markers
The endpoints for assessment of pharmacodynamic activity include induction of proliferation markers in various lymphoctye subsets, immunohistochemistry of tumor biopsies and assessment of programmed death ligand 1 (PD-L1) and tumor-infiltrating lymphocyte phenotypic markers
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Research Site
Minneapolis, Minnesota, United States
Research Site
New York, New York, United States
Research Site
The Bronx, New York, United States
Research Site
Huntersville, North Carolina, United States
Research Site
Portland, Oregon, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Dallas, Texas, United States
...and 2 more locations
Time frame: From time of informed consent through 12 weeks after last dose of investigational product
Disease control rate (DCR)
The DCR is defined as the proportion of subjects with irCR, irPR, or irSD (subjects achieving irSD will be included in the DCR if they maintain irSD for ≥8 weeks)
Time frame: Estimated to be from time of informed consent up to 5 years
Duration of response (DoR)
Duration of response will be defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Time frame: Estimated to be from time of informed consent up to 5 years
Progression-free survival (PFS)
Progression-free survival will be measured from the start of treatment with MEDI0562 until the first documentation of confirmed immune-related disease progression or death due to any cause, whichever occurs first.
Time frame: Estimated to be from time of informed consent up to 5 years
Overall survival (OS)
Overall survival will be determined as the time from the start of treatment with MEDI0562 until death due to any cause.
Time frame: Estimated to be from time of informed consent up to 5 years