This is a first in human, open-label, sequential dose escalation and expansion study of AMG 780 in up to 62 subjects with advanced solid tumors. The dose escalation part of the study is aimed at evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 780. The dose expansion will consist of up to 20 subjects and the dose level of AMG 780 will be dependent upon emerging safety and PK data from the dose escalation part of the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
AMG 780 will be administered by IV infusion every 2 weeks
Research Site
Los Angeles, California, United States
Research Site
Durham, North Carolina, United States
Research Site
Cleveland, Ohio, United States
To assess the safety and tolerability of AMG 780 in subjects with advanced solid malignancies (including adverse event rate, incidence of dose-limiting toxicities, and determination of maximum tolerated dose)
Time frame: 2.5 years
To evaluate the pharmacokinetic (PK) parameters of AMG 780 including, but not limited to Cmax, AUC, and accumulation ratio
Time frame: 2.5 years
To evaluate tumor response using RECIST criteria (measured by CT/MRI)
Time frame: 2.5 years
To evaluate changes in tumor volume (measured by volumetric CT/MRI)
Time frame: 2.5 years
To evaluate changes in tumor vascularity and to estimate the relationship between dose/pharmacokinetics and vascular response (measured by DCE-MRI)
Time frame: 2.5 years
To evaluate the incidence of anti-AMG 780 antibody formation
Time frame: 2.5 years
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