18 and older, any sex, with Locally Advanced Pancreatic Ductal Adenocarcinoma or Metastatic Pancreatic Ductal Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Incidence of Grade 3 or 4 Adverse EventsPrimary· 1 year
The number (percentage) of all subjects who experience Grad 3 or 4 treatment emergent adverse events (AEs), serious adverse events (SAEs), or abnormal laboratory results according to NCI CTCAE Version 5.0, that occur after Cycle 1, Day 1 will be reported until end of treatment visit.
Group
Value
95% CI
Eryaspase Dose Level 0 (75 Units/kg) Plus FOLFIRINOX
2
Eryaspase Dose Level 1 (100 Units/kg) Plus FOLFIRINOX
8
Objective Response Rate by RECIST 1.1Secondary· 2 years
Number of participants with a complete or partial response from treatment as assessed by CT scan per RECIST 1.1 criteria.
Group
Value
95% CI
Eryaspase Dose Level 0 (75 Units/kg) Plus FOLFIRINOX
1
Eryaspase Dose Level 1 (100 Units/kg) Plus FOLFIRINOX
3
Progression-free Survival (PFS)Secondary· 3 years
Time in months from start of treatment to disease progression, death, or completion of study which ever occurred first.
Group
Value
95% CI
Eryaspase Dose Level 0 (75 Units/kg) Plus FOLFIRINOX
5.6
1.8 – 28.3
Eryaspase Dose Level 1 (100 Units/kg) Plus FOLFIRINOX
6.4
0.4 – 34.7
Overall Survival (OS)Secondary· 3 years
The length of time from treatment initiation until death from any cause or off study date, whichever occurs first.
Group
Value
95% CI
Eryaspase Dose Level 0 (75 Units/kg) Plus FOLFIRINOX
10.2
8.7 – 28.3
Eryaspase Dose Level 1 (100 Units/kg) Plus FOLFIRINOX
8.6
0.4 – 34.7
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Eryaspase Dose Level 0 (75 Units/kg) Plus FOLFIRINOX
Serious: 1/3 (33%)
Deaths: 3/3
Eryaspase Dose Level 1 (100 Units/kg) Plus FOLFIRINOX
Serious: 2/16 (13%)
Deaths: 13/16
Serious adverse events (4 terms)
Reaction
System
Eryaspase Dose Level 0 (75…
Eryaspase Dose Level 1 (10…
Hypotension
Vascular disorders
—
—
Sepsis
Infections and infestations
—
—
Atrial fibrillation
Cardiac disorders
—
—
Syncope
Nervous system disorders
—
—
Other adverse events (87 terms — click to expand)
Reaction
System
Eryaspase Dose Level 0 (75…
Eryaspase Dose Level 1 (10…
Fatigue
General disorders
—
—
Anemia
Blood and lymphatic system disorders
—
—
Peripheral sensory neuropathy
Nervous system disorders
—
—
Diarrhea
Gastrointestinal disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Alanine aminotransferase increased
Investigations
—
—
Alkaline phosphatase increased
Investigations
—
—
Platelet count decreased
Investigations
—
—
Constipation
Gastrointestinal disorders
—
—
White blood cell decreased
Investigations
—
—
Vomiting
Gastrointestinal disorders
—
—
Aspartate aminotransferase increased
Investigations
—
—
Hypokalemia
Metabolism and nutrition disorders
—
—
GGT increased
Investigations
—
—
Mucositis oral
Gastrointestinal disorders
—
—
Edema limbs
General disorders
—
—
Anorexia
Metabolism and nutrition disorders
—
—
Hyperglycemia
Metabolism and nutrition disorders
—
—
Dysgeusia
Nervous system disorders
—
—
Hyponatremia
Metabolism and nutrition disorders
—
—
Blood lactate dehydrogenase increased
Investigations
—
—
Lipase increased
Investigations
—
—
Neutrophil count decreased
Investigations
—
—
Weight loss
Investigations
—
—
Back pain
Musculoskeletal and connective tissue disorders
—
—
Pain in extremity
Musculoskeletal and connective tissue disorders
—
—
Cough
Respiratory, thoracic and mediastinal disorders
—
—
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
—
—
Hypotension
Vascular disorders
—
—
Thromboembolic event
Vascular disorders
—
—
Abdominal pain
Gastrointestinal disorders
—
—
Flatulence
Gastrointestinal disorders
—
—
General disorders and administration site conditions - Other, specify
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).
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Georgetown University
Last refreshed: 11 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04292743.