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 (May 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
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 →
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