The purpose of this study is to evaluate the safety, pharmacokinetics, anti-tumor activity, and identify a tolerable dose of AMG 228 in subjects with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
AMG 228 will be administered intravenously
Research Site
La Jolla, California, United States
Research Site
New Haven, Connecticut, United States
Research Site
New York, New York, United States
Research Site
Parkville, Victoria, Australia
Research Site
Leuven, Belgium
Research Site
Villejuif, France
Research Site
Heidelberg, Germany
Subject incidence of dose limiting toxicities (DLT)
Time frame: 9 months
Subject incidence of treatment-emergent adverse events
Time frame: 9 months
Subject incidence of treatment-related adverse events
Time frame: 9 months
Subject incidence of clinically significant changes in vital signs and physical assessments
Time frame: 9 months
Subject incidence of clinically significant changes in ECGs
Time frame: 9 months
Subject incidence of clinically significant changes in clinical laboratory tests
Time frame: 9 months
AMG 228 maximum observed concentration (Cmax)
Time frame: 9 months
AMG 228 minimum observed concentration (Cmin)
Time frame: 9 months
AMG 228 area under the concentration-time curve (AUC)
Time frame: 9 months
AMG 228 half-life (t1/2)
Time frame: 9 months
Subject objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: 9 months
Incidence of anti-AMG 228 antibody formation
Time frame: 9 months
Activation status and changes in numbers of T regulator cells (Treg)
Time frame: 9 months
Subject objective response per immune-related Response Criteria (irRC)
Time frame: 9 months
Activation status of cytotoxic T lymphocytes (CTL)
Time frame: 9 months
Changes in numbers of cytotoxic T lymphocytes (CTL)
Time frame: 9 months
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