Study Complete
Sponsor ID
20180144

Study of AMG 256 in Adult Subjects With Advanced Solid Tumors

Sponsor ID
20180144
Clinicaltrials.gov ID
NCT04362748
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

To evaluate the safety and tolerability of AMG 256 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

Additional Study Details

Phase
Phase 1
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
34
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants with Dose Limiting Toxicities (DLTs)

Timeframe: 28 days

Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to 2.5 Years

Number of Participants with Treatment-Related Adverse Events

Timeframe: Up to 2.5 Years

Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurement

Timeframe: Up to 2 Years

Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests

Timeframe: Up to 2 Years

Maximum Tolerated Dose (MTD) of AMG 256

Timeframe: 28 days

Recommended Phase 2 Dose (RP2D) of AMG 256

Timeframe: 28 days

Secondary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of AMG 256

Timeframe: Up to 2.5 Years

Time to Achieve Cmax (Tmax) of AMG 256

Timeframe: Up to 2.5 Years

Area Under the Plasma Concentration-time Curve (AUC) of AMG 256

Timeframe: Up to 2.5 Years

Objective Response (OR)

Timeframe: Up to 2.5 Years

Duration of Response (DOR)

Timeframe: Up to 2.5 Years

Progression-Free Survival (PFS)

Timeframe: Up to 1 Year

Disease Control Rate (DCR)

Timeframe: Up to 2.5 Years

Duration of Stable Disease

Timeframe: Up to 2.5 Years

Overall Survival (OS)

Timeframe: Up to 2 Years

Number of Participants with anti-AMG 256 Antibodies

Timeframe: Up to 2.5 Years

Locations

Location
Status
Contact Us
Location
Indiana University
Indianapolis, IN, United States, 46202
Status
Recruiting
Location
Monash Medical Centre
Clayton, VIC, Australia, 3168
Status
Recruiting
Location
St Vincents Hospital Sydney
Darlinghurst, NSW, Australia, 2010
Status
Recruiting
Location
Hospital Universitari Vall d Hebron
Barcelona, Cataluña, Spain, 08035
Status
Recruiting
Location
Hospital Clinic i Provincial de Barcelona
Barcelona, Cataluña, Spain, 08036
Status
Recruiting
Location
Chris OBrien Lifehouse
Camperdown, NSW, Australia, 2050
Status
Recruiting
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