A Phase 1 Multiple Dose, Dose Escalation Trial of AEB1102 (Co-ArgI-PEG) in Patients with Advanced Solid Tumors

Protocol: 
AAAR1316
Phase: 
I

A Phase 1 Multiple Dose, Dose Escalation Trial of AEB1102 (Co-ArgI-PEG) in Patients with Advanced Solid Tumors

This is a Phase 1 multiple dose, dose escalation trial in patients with advanced solid tumors who have failed or cannot tolerate standard therapies. Your study doctor has determined that you have an advanced cancer (solid tumor). You are invited to take part in this research study. This study has two parts. In Part 1, the dose escalation portion, the purpose of the study is to determine the highest dose that can be safely given to subjects (the Maximum Tolerated Dose [MTD]) or a dose that is considered most effective to treat your cancer. In Part 2, or expansion portion, the purpose of the study is to learn more about the safety of AEB1102 in patients with advanced solid tumors of specific type, to understand the effects of AEB1102 on levels of L-Arginine in blood and, when possible, on tumor tissue and to study the effects of AEB1102 on tumor growth. Up to 48 subjects with advanced solid tumors will be joining Part 1 of this study and up to 75 subjects with advanced solid tumors will be joining Part 2 of this study.

Are you Eligible? (Inclusion Criteria)

1. Has an advanced solid tumor, has failed or cannot tolerate standard therapy
for the disease and as such is considered a candidate for Phase 1 treatment.

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States