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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
IV Infusion Dose Escalation (Part 1) - 5 Dose Cohorts Dose Expansion (Part 2) - 30 patients
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
To evaluate the safety and tolerability of U3-1287 (AMG888) in patients with advanced solid tumors
Time frame: Lenth of study
To evaluate maximum tolerated dose (MTD) of U3-1287(AMG888) when administered intravenously to patients with advanced solid tumors
Time frame: Lenth of study
Pharmacokinetic Parameters
Time frame: Length of study
Pharmacodynamic Parameters
Time frame: Length of study
Human anti-human antibody profile for U3-1287(AMG888)
Time frame: Length of study
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