OncoMatch/Clinical Trials/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.
Is NCT07157033 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies XER-001 for locally advanced pancreatic adenocarcinoma.
Treatment: XER-001 — The purpose of this study is to assess the safety, tolerability and efficacy of XER-001 and identify a best dose for future studies.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Pancreatic Cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy (FOLFIRINOX, gemcitabine/abraxane) — first line
Completion of medically indicated first line systemic therapy, which may include but is not limited to regimens such as FOLFIRNOX, gemcitabine/abraxane, and similar regimens
Cannot have received: radiotherapy
Prior radiotherapy to the upper abdomen with overlap of the anticipated SBRT field
Cannot have received: radiopharmaceutical therapy
Prior radiopharmaceutical therapy
Cannot have received: surgical resection
Prior surgical resection of the pancreatic tumor
Lab requirements
Blood counts
Absolute neutrophil counts ≥ 1500/mm3; Hemoglobin ≥ 8.0 g/dL; Platelet count ≥ 75,000/mm3
Kidney function
Estimated glomerular filtration rate of less than 30 mL per minute are excluded
Liver function
Total bilirubin ≤ 1.5x ULN; AST and ALT ≤ 2.5x ULN; No known liver disease or hepatic impairment; No recent or current use of hepatotoxic drugs or substances unless a washout period has been completed
Cardiac function
Normal sinus rhythm (heart rate 40-100 bpm); QTcF ≤ 470 msec; QRS ≤ 110 msec; PRS ≤ 220 msec; No clinically significant ECG findings as judged by investigator
Adequate hematologic function as indicated by: Absolute neutrophil counts ≥ 1500/mm3, Hemoglobin ≥ 8.0 g/dL, Platelet count ≥ 75,000/mm3; Adequate liver function as indicated by: Total bilirubin ≤ 1.5x ULN, AST and ALT ≤ 2.5x ULN; No known liver disease or hepatic impairment; No recent or current use of hepatotoxic drugs or substances unless a washout period has been completed; Baseline serum calcium level ≥ 8.4 mg/dL; Normal sinus rhythm (heart rate between 40 and 100 bpm); QTcF interval ≤ 470 msec; QRS interval ≤ 110 msec; PRS interval ≤ 220 msec
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Christus St. Vincent Regional Cancer Center · Santa Fe, New Mexico
- Oncology Consultants, P.A. · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07157033 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radiotherapy, radiopharmaceutical therapy, surgical resection disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages