RecruitingPhase 1Phase 2NCT07157033

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


Sponsor

Xerient Pharma

Enrollment

36 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called XER-001 (a modified form of amifostine, a cell-protecting medication) delivered through a tube into the small intestine, combined with a precise radiation therapy called stereotactic body radiation therapy (SBRT), for people with locally advanced pancreatic cancer that cannot be surgically removed. **You may be eligible if...** - You have a confirmed diagnosis of pancreatic adenocarcinoma (a specific type of pancreatic cancer) - Your tumor has been determined to be unresectable (cannot be surgically removed) or you are not a candidate for surgery due to other health conditions - There is no evidence of cancer spread to distant organs - You are in good enough physical condition to tolerate radiation therapy **You may NOT be eligible if...** - Your cancer has already spread to distant organs (metastatic) - Your tumor has grown into (invaded) the bowel - You are unwilling or unable to follow the study protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXER-001

XER-001 (Amifostine for nasoduodenal delivery)


Locations(4)

City of Hope

Duarte, California, United States

CIty of Hope

Irvine, California, United States

Christus St. Vincent Regional Cancer Center

Santa Fe, New Mexico, United States

Oncology Consultants, P.A.

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07157033


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