Terminated/Withdrawn
Sponsor ID
20180290

Study of AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal Junction, Colorectal, and Pancreatic Cancers

Sponsor ID
20180290
Clinicaltrials.gov ID
NCT04117958
EUCTIS ID
N/A
EudraCT ID
2019-002708-42

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).

Additional Study Details

Phase
Phase 1
Product
AMG 199
Type
Interventional
Masking
None (Open Label)
Enrollment
58
Additional Study Details

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
Status
Contact Us
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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