GPT and acute pancreatitis: SAEs were reported in a total of 10 patients (62.5%), 4 patients experienced treatment-related SAEs including grade 3 acute pancreatitis requiring hospitalization following 15 cycles of study therapy (n = 1), grade 3 maculopapular rash (n = 1, DLT), grade 3 rectal hemorrhage (n = 1, DLT) and a patient who developed grade 3 AST and grade 4 ALT elevation following 3 cycles of study therapy.