Spots Global Cancer Trial Database for Phase I Study of U3P1287/01, Including Patients With Advanced Solid Tumors
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Trial Identification
Brief Title: Phase I Study of U3P1287/01, Including Patients With Advanced Solid Tumors
Official Title: A Phase I, Open-label, Dose-Finding Study to Assess the Safety and Tolerability of U3-1287 (AMG 888), a Human Monoclonal Antibody Targeting HER3 in Patients With Advanced Solid Tumors.
Study ID: NCT00730470
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
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