The study is an open-label, dose-escalation trial expected to enroll up to 18 patients and to test three dose levels of FG-3019 administered via infusion every two weeks. After the second administration of FG-3019, patients will initiate treatment with gemcitabine and erlotinib. Patients will continue on FG-3019 treatment until disease progression as assessed by the response evaluation criteria in solid tumors.
Secondary objectives of the study are to evaluate the activity and pharmacokinetics of FG-3019 in combination with gemcitabine and erlotinib.
The study is being conducted at two sites: at Stanford University School of Medicine, Stanford, California, where Albert Koong is principal investigator and at Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, where Marc Pipas is principal investigator.