Terminated/Withdrawn
Sponsor ID
20180273

Study of AMG 160 in Subjects with Non-Small Cell Lung Cancer

Sponsor ID
20180273
Clinicaltrials.gov ID
NCT04822298
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

This study aims to evaluate the safety and tolerability of AMG 160 and to evaluate the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D).

Additional Study Details

Phase
Phase 1
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
3
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants who Experience One or More Dose-limiting Toxicities (DLTs)

Timeframe: 28 days

Number of Participants who Experience One or More Treatment-emergent Adverse Event (TEAE)

Timeframe: Up to 3 years

Number of Participants who Experience One or More Treatment-related Adverse Events

Timeframe: Up to 3 years

Number of Participants who Experience Clinically Significant Changes in Vital Signs

Timeframe: Up to 3 years

Number of Participants who Experience Clinically Significant Changes in Clinical Laboratory Tests

Timeframe: Up to 3 years

Secondary Outcome Measures

Objective Response (OR) per Modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Timeframe: Up to 3 years

Overall Survival

Timeframe: Up to 3 years

Progression-free Survival (PFS)

Timeframe: Up to 3 years

Time to Response

Timeframe: Up to 3 years

Time to Progression

Timeframe: Up to 3 years

Duration of Response

Timeframe: Up to 3 years

Time to Subsequent Therapy

Timeframe: Up to 3 years

Locations

Location
Status
Contact Us
Location
Chris OBrien Lifehouse
Camperdown, NSW, Australia, 2050
Status
Recruiting
Location
Landeskrankenhaus Salzburg
Salzburg, Austria, 5020
Status
Recruiting
Location
University of Texas MD Anderson Cancer Center
Houston, TX, United States, 77030
Status
Completed
Location
Universitaetsklinikum Allgemeines Krankenhaus Wien
Wien, Austria, 1090
Status
Completed