Phase 12a Study of XER-001 with Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of XER-001, a drug delivered nasoduodenally, combined with stereotactic body radiotherapy SBRT for patients with locally advanced pancreatic cancer. This phase 12a open-label study aims to find the best dose of XER-001 for future research and assess how increasing duodenal radiation doses affect treatment outcomes. Participants will receive XER-001 at gradually increasing doses alongside SBRT. The study has two parts phase 1 focuses on safety, tolerability, and pharmacokinetics of XER-001 with SBRT, while phase 2a evaluates safety and efficacy with more flexible duodenal radiation limits. Treatments are given according to detailed schedules to monitor effects and determine optimal dosing. During the study, participants will undergo various assessments including safety evaluations over 18 to 40 months, and antitumor activity monitoring for up to 40 months. Researchers will track side effects, lab tests, imaging, and other health measures. Participants will follow a strict protocol including breath-hold or motion management techniques during radiotherapy. Overall involvement includes multiple visits and tests to ensure safety and measure treatment impact throughout the trial.

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.