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).
AMG 199 is a novel half-life extended (HLE) bispecific T cell engager (BiTE®) molecule designed to direct T cells towards MUC17-expressing cells. This is a first-in-human study in adult subjects with MUC17-positive solid tumors including gastric cancer, gastroesophageal junction (GEJ), colorectal, and pancreatic cancers, collectively referred to as "solid tumors" in this clinical investigation to assess AMG 199 safety, tolerability, pharmacokinetics (PK), and anti-tumor activity, with additional exploratory objectives to assess pharmacodynamics (PD), correlative biomarker analysis, and immunogenicity. The primary end point is to evaluate the safety and tolerability of AMG 199 in adult subjects, and determine the MTD and RP2D. The secondary end point is characterize the PK and anti-tumor activity of AMG 199.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
AMG 199 is a BiTE® molecule designed to direct T cells towards MUC17-expressing cells.
City of Hope National Medical Center
Duarte, California, United States
Incidence of Dose-limiting toxicities (DLT)
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).
Time frame: 3 years
Incidence of Treatment-emergent adverse events (TEAEs)
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).
Time frame: 3 years
Incidence of Treatment-related adverse events (TRAEs)
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).
Time frame: 3 years
Number of subjects with changes in vital signs
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).
Time frame: 3 years
Number of subjects with changes in clinical laboratory tests
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).
Time frame: 3 years
Number of subjects with changes in electrocardiogram (ECG)
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).
Time frame: 3 years
Maximum serum concentration (Cmax) of AMG 199
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University of California at Irvine Medical Center
Orange, California, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Landeskrankenhaus Salzburg
Salzburg, Austria
Institut Gustave Roussy
Villejuif, France
Universitaetsklinikum Hamburg Eppendorf Onkologisches Zentrum
Hamburg, Germany
Universitaetsklinikum Leipzig
Leipzig, Germany
Klinikum der Universitaet Muenchen Campus Grosshadern
München, Germany
Klinikum rechts der Isar
München, Germany
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
...and 11 more locations
To characterize the PK (Pharmacokinetics) of AMG 199.
Time frame: 3 years
Minimum serum concentration (Cmin) of AMG 199
To characterize the PK (Pharmacokinetics) of AMG 199.
Time frame: 3 years
Area under the concentration-time curve (AUC) of AMG 199
To characterize the PK (Pharmacokinetics) of AMG 199.
Time frame: 3 years
Accumulation following multiple dosing of AMG 199
To characterize the PK (Pharmacokinetics) of AMG 199.
Time frame: 3 years
Half-life (t1/2) of AMG 199
To characterize the PK (Pharmacokinetics) of AMG 199.
Time frame: 3 years
Objective response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and iRECIST.
To evaluate preliminary anti-tumor activity of AMG 199
Time frame: 3 years
Duration of response (DOR).
To evaluate preliminary anti-tumor activity of AMG 199
Time frame: 3 years
Time to progression (TTP)
To evaluate preliminary anti-tumor activity of AMG 199
Time frame: 3 years
Progression-free survival (PFS), 6-month PFS
To evaluate preliminary anti-tumor activity of AMG 199
Time frame: 6 months
Progression-free survival (PFS), 1-year PFS
To evaluate preliminary anti-tumor activity of AMG 199
Time frame: 1 year
Overall survival (OS), 1-year OS.
To evaluate preliminary anti-tumor activity of AMG 199
Time frame: 1 year
Overall survival (OS), 2-year OS
To evaluate preliminary anti-tumor activity of AMG 199
Time frame: 2 years