NCT07157033

A Phase 1 Study to Evaluate Safety and Efficacy of XER-001 (Amifostine for Nasoduodenal Delivery) in Combination With Sterotactic Body Radiotherapy for Treatment in Patients With Locally Advanced Pancreatic Cancer.

A Phase 1/2a, Open Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of XER-001 (Amifostibe for Nasoduodenal Delivery) in Combination With Sterotactic Body Radiotherapy for Treatment of Locally-Advanced Pancreatic Adenocarcinoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Xerient Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety, tolerability and efficacy of XER-001 and identify a best dose for future studies.

Detailed description

The primary objective of the phase 1 component of the study is to evaluate the safety, tolerability, and PK of nasoduodenal administration of XER-001 in conjunction with stereotactic body radiotherapy (SBRT) in patients with LAPC. The primary objective of the phase 2a component of the study is to evaluate safety and efficacy of combination SBRT and XER-001 with increasingly-liberalized duodenal radiation dose constraints.

Conditions

• Locally Advanced Pancreatic Adenocarcinoma
• Locally Advanced Pancreas Cancer
• Locally Advanced Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	XER-001	XER-001 (Amifostine for nasoduodenal delivery)

Timeline

• Start date: 2026-01-01
• Primary completion: 2029-07-31
• Completion: 2034-07-31
• First posted: 2025-09-05
• Last updated: 2026-02-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study