Study Complete
Sponsor ID
20060347

A Study of AMG 820 in Subjects with Advanced Solid Tumors

Sponsor ID
20060347
Clinicaltrials.gov ID
NCT01444404
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

First in human, open-label, sequential dose escalation and expansion study of AMG 820 in subjects with advanced solid tumors.

Additional Study Details

Phase
Phase 1
Product
AMG 820
Type
Interventional
Masking
None (Open Label)
Enrollment
25
Additional Study Details

Protocol Summary

Primary Outcome Measures

Area Under Curve (AUC) Time Frame: predose, 0.5, 1, 2, 4, 8, 24 hours post-dose

Timeframe: 3 years

Dose of AMG 820 where clinically significant or ≥ Grade 3 changes in safety laboratory tests, physical examinations, ECGs, or vitals signs in all subjects enrolled is greater than 33%.

Timeframe: 3 years

Change in tumor associated macrophages (TAMS) as assessed by tumor biopsy at 9 weeks.

Timeframe: 3 years

Secondary Outcome Measures
Not Available

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Philadelphia, PA, United States, 19111
Status
Recruiting
Location
Research Site
San Antonio, TX, United States, 78229
Status
Recruiting
Location
Research Site
Greenville, SC, United States, 29605
Status
Recruiting