Eryaspase With Modified FOLFIRINOX in Advanced Pancreatic Ductal Adenocarcinoma
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
This will be a single-arm, multi-center, open-label phase 1 study. The standard 3+3 design
will be used to determine the maximum tolerated dose (MTD) from 4 possible dose levels of
Eryaspase in combination with mFOLFIRINOX. We hypothesize that the addition of Eryaspase to
FOLFIRINOX (5-fluorouracil [5-FU], leucovorin, irinotecan, and oxaliplatin) will be safe and
demonstrate preliminary signs of efficacy in patients with advanced pancreatic cancer. Safety
assessments include adverse events, physical examination abnormalities, vital signs, and
clinical laboratory tests (including blood chemistry, hematology, and coagulation panel).