This primary purpose of this study is to estimate the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) and preferred dosing schedule of LJM716 given by IV infusion in adult patients with squamous cell carcinoma of head and neck, or esophagus, or HER2 overexpressing metastatic breast cancer or gastric cancer
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
University of Chicago Medical Center University of Chicago (16)
Chicago, Illinois, United States
Massachusetts General Hospital SC-5
Boston, Massachusetts, United States
University of Texas/MD Anderson Cancer Center UT MD
Houston, Texas, United States
University of Utah / Huntsman Cancer Institute Huntsman
Salt Lake City, Utah, United States
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Taipei, Taiwan
Dose-limiting toxicities (DLTs)
Time frame: 4 weeks
Adverse events
Time frame: 4 months
Serious adverse events
Time frame: 4 months
Pharmacodynamic response to LJM716 in tumor tissue
Time frame: 3 months
Frequency of partial responses, complete responses and stable disease according to RECIST
Time frame: every 2 months
Serum concentration of antibodies to LJM716
Time frame: 18 months
Progression-free survival
Time frame: 18 months
Duration of response
Time frame: 18 months
Serum concentration of LJM716,
Time frame: 4 months
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