drugset
drugset / Trial / NCT04292743

Eryaspase With Modified FOLFIRINOX in Advanced Pancreatic Ductal Adenocarcinoma

NCT04292743 ↗

Phase 1 Completed 19 enrolled Georgetown University ERYtech Pharma · collab
Non-randomizedSequentialOpen-labelTreatment

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).

Timeline

Start
2020-12-02
Primary completion
2023-01-18
Completion
2024-03-04

Drugs

EvaluationDrugModalityDoseRoute
Subject GRASPA Protein / enzyme biologic 25 iu/kg Intravenous
Subject GRASPA Protein / enzyme biologic 50 iu/kg Intravenous
Subject GRASPA Protein / enzyme biologic 75 iu/kg Intravenous
Subject GRASPA Protein / enzyme biologic 100 iu/kg Intravenous
Background Irinotecan Small molecule 150 mg/m2 Intravenous
Background Leucovorin Small molecule — Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications

pancreatic ductal adenocarcinoma