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Phase I Dose Escalation Study of Eryaspase in Combination With Modified FOLFIRINOX in Locally Advanced and Metastatic Pancreatic Ductal Adenocarcinoma

Summary

The purpose of this phase I, single-arm, multi-center, open-label study is 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).

General Information

NCT#: NCT04292743
Study ID: STUDY00002008
Trial Phase: Phase I

Trial Sponsor: Georgetown University, ERYtech Pharma
Therapies Used in This Trial: Fluorouracil, Oxaliplatin, Irinotecan, Leucovorin, FOLFIRINOX, Eryaspase

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