Terminated/Withdrawn
Sponsor ID
20180290
Study of AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal Junction, Colorectal, and Pancreatic Cancers
Study Details
To evaluate the safety and tolerability of AMG 199 in adult subjects and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
Protocol Summary
Primary Outcome Measures
Incidence of Dose-limiting toxicities (DLT)
Timeframe: 3 years
Incidence of Treatment-emergent adverse events (TEAEs)
Timeframe: 3 years
Incidence of Treatment-related adverse events (TRAEs)
Timeframe: 3 years
Number of subjects with changes in vital signs
Timeframe: 3 years
Number of subjects with changes in clinical laboratory tests
Timeframe: 3 years
Number of subjects with changes in electrocardiogram (ECG)
Timeframe: 3 years
Secondary Outcome Measures
Maximum serum concentration (Cmax) of AMG 199
Timeframe: 3 years
Minimum serum concentration (Cmin) of AMG 199
Timeframe: 3 years
Area under the concentration-time curve (AUC) of AMG 199
Timeframe: 3 years
Accumulation following multiple dosing of AMG 199
Timeframe: 3 years
Half-life (t1/2) of AMG 199
Timeframe: 3 years
Objective response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and iRECIST.
Timeframe: 3 years
Duration of response (DOR).
Timeframe: 3 years
Time to progression (TTP)
Timeframe: 3 years
Progression-free survival (PFS), 6-month PFS
Timeframe: 6 months
Progression-free survival (PFS), 1-year PFS
Timeframe: 1 year
Overall survival (OS), 1-year OS.
Timeframe: 1 year
Overall survival (OS), 2-year OS
Timeframe: 2 years
Locations
Location
City of Hope National Medical Center
Duarte, CA, United States, 91010
Status
Recruiting
Location
Wake Forest University Health Sciences
Winston-Salem, NC, United States, 27157
Status
Recruiting
Location
University of California at Irvine Medical Center
Orange, CA, United States, 92868
Status
Recruiting
Location
Aichi Cancer Center
Nagoya-shi, Aichi, Japan, 464-8681
Status
Recruiting
Location
Universitaetsklinikum Hamburg Eppendorf Onkologisches Zentrum
Hamburg, Germany, 20246
Status
Recruiting
Location
Klinikum der Universitaet Muenchen Campus Grosshadern
Muenchen, Germany, 81377
Status
Recruiting
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