Phase I Study of U3P1287/01, Including Patients With Advanced Solid Tumors
Completed · Phase 1
Conditions studied: Advanced Solid Tumors
In brief
This is a Phase 1 clinical study to investigate the safety, pharmacokinetics, and pharmacodynamics of U3-1287 (AMG 888), a fully human monoclonal antibody targeting the HER3 receptor, in patients with advanced solid tumors. Eligible patients will have disease that is refractory or resistant to standard treatments or for which no standard therapy exists. The study will be conducted in two parts; a dose escalation (Part 1) and a dose expansion (Part 2). The hypothesis for this study is that U3-1287 (AMG888) will be safe and well tolerated in patients with advanced solid tumors and will show initial evidence of anti-tumor activity.
Key facts
- Study ID
- NCT00730470
- Run by
- U3 Pharma GmbH
- People needed
- 60
- Starts
- 2008-08-01
- Expected to finish
- 2010-07-01
- Last updated by the study team
- 2010-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Dana Faber Cancer Institute — Boston, Massachusetts, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Karmanos Cancer Institute — Detroit, Michigan, United States
- Memorial Sloan-Kettering Cancer Centre — New York, New York, United States
- Vanderbilt Ingram cancer Centre — Nashville, Tennessee, United States
- Northwest Medical Specialties — Tacoma, Washington, United States
Full record on ClinicalTrials.gov
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