The purpose of this study is to assess the safety, tolerability and efficacy of XER-001 and identify a best dose for future studies.
Cytologic or biopsy confirmed adenocarcinoma of the pancreas
Locally-advanced and/or technically unresectable, as determined by a specialist pancreaticobiliary surgeon and as part of a multidisciplinary team review including of multiphase cross-sectional imaging, demonstrating: i. Greater than 180-degree tumor involvement of the superior mesenteric artery (SMA) ii. Greater than 180-degree tumor involvement of the celiac axis including major branches of the celiac axis that would render the tumor unresectable (e.g. common hepatic artery) iii. Tumor involvement of the first branch of the SMA that is not surgically reconstructible iv. Long segment involvement of the superior mesenteric vein/portal vein/hepatic artery that is not amenable to surgical reconstructible.
Potentially resectable anatomically but deemed not a surgical candidate after multidisciplinary review (such as unresectable due to comorbid conditions that render.
Potentially resectable but the patient elects to refuse surgery and prefers to pursue SBRT, and disease is deemed eligible for SBRT
Prior radiotherapy to the upper abdomen with overlap of. the anticipated SBRT field
Prior radiopharmaceutical therapy
Prior surgical resection of the pancreatic tumor
Uncontrolled or active gastric or duodenal ulcer disease within 30 days of enrollment
Single group
XER-001
DrugXER-001 (Amifostine for nasoduodenal delivery)
Safety Assessments [Dose Escalation]
Incidence of Dose Limiting Toxicities (DLTs) in DLT-evaluable subjects
Safety Assessments [Dose Escalation]
Identify the maximum tolerated dose and the RP2D
Safety Assessments [Dose escalation and Dose Expansion]
Number of participants with Serious Adverse Events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Safety Assessments [Dose Escalation and Dose Expansion]
Number of participants with Treatment-related Adverse Events (AEs) graded per NCI-CTCAE version 5.0
Antitumor Activity
Local disease control at 6 months per RECIST 1.1
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