Phase 1/2 study of FG-3019 for the treatment of pancreatic cancer

FibroGen announced interim results of a Phase 1/2 trial of FG-3019 in combination with gemcitabine and erlotinib in patients with unresectable pancreatic cancer. The trial is an open-label, single-arm, dose-escalation study to evaluate safety, tolerability, pharmacokinetics and ability of FG-3019 administered every 2 weeks to improve outcomes in chemotherapy-naïve patients with unresectable pancreatic cancer. Therapy with gemcitabine and erlotinib starts at day 15, concomitant with administration of the second dose of FG-3019.

Enrollment in the first 4 dose cohorts (3, 10, 15, and 25 mg/kg FG-3019) is complete, and FG-3019 has been well-tolerated at all doses. Assessments of tumor response measured by CT are made according to Response Evaluation Criteria in Solid Tumors 1.0 (RECIST 1.0) guidelines at baseline and every 8 weeks. For dose cohorts of 15 mg/kg and higher, tumor metabolic activity is measured by PET at baseline and day 14 (prior to administration of chemotherapy).

FG-3019 is a fully human therapeutic antibody designed to inhibit the activity of connective tissue growth factor (CTGF), a matricellular protein that modulates the activity of growth factors, adhesion molecules, integrins, and extracellular matrix.

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