Actively Recruiting
A Phase 1/2a, Open Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of XER-001 (Amifostine for Nasoduodenal Delivery) with Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Adenocarcinoma
Led by Xerient Pharma · Updated on 2026-05-01
36
Participants Needed
4
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
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 1/2a 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.
CONDITIONS
Brief Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cytologic or biopsy confirmed adenocarcinoma of the pancreas
- Disease suitable for definitive treatment with stereotactic body radiotherapy (SBRT) judged locally advanced or unresectable by a specialist team
- Potentially resectable but not a surgical candidate or patient refuses surgery and prefers SBRT
- No distant metastatic disease before or after systemic therapy
- Completed medically indicated first-line systemic therapy such as FOLFIRINOX or gemcitabine/abraxane
- Ability to understand and comply with SBRT treatment procedures including motion management
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Adequate blood counts including neutrophils, hemoglobin, and platelets
- Adequate liver function with specified lab values
- Baseline serum calcium level of at least 8.4 mg/dL
- Normal 12-lead ECG without significant abnormalities
- Willingness and ability to comply with all study procedures
- Written informed consent given
- Women of child-bearing potential must use effective contraception before and for six months after radiotherapy; men with partners who can become pregnant must also use contraception during and for three months after radiotherapy
You will not qualify if you...
- Prior radiotherapy to the upper abdomen overlapping the planned SBRT area
- Prior radiopharmaceutical therapy
- Prior surgical removal of the pancreatic tumor
- Active or uncontrolled gastric or duodenal ulcers within 30 days
- Visible tumor invasion into bowel, stomach, or duodenal lumen on endoscopy
- Ongoing severe non-blood-related side effects from chemotherapy
- Concurrent participation in another interventional trial or use of investigational agents within 30 days
- Uncontrolled illnesses such as active infections, heart failure, unstable angina, renal failure, or arrhythmia
- Recent history (within 6 months) of heart attack or unstable angina
- History of severe low calcium or hypoparathyroidism
- Unsafe to interrupt blood pressure medication
- Low blood pressure at screening
- Diseases affecting drug metabolism or study assessments including severe kidney or liver impairment
- History of serious cardiac conditions or electrical heart abnormalities
- Medical issues likely to prevent study completion
- Inability to fast for 3 hours before study drug
- Active hepatitis B/C or untreated HIV infection
- Recent significant blood donation or loss
- Difficulty with venous access or unwillingness for catheter insertion
- Pregnant or breastfeeding women
- Employment or close relation to study sponsor or site staff
- Investigator considers participant unsuitable or unlikely to comply with protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 months during dose escalation, up to 40 months including dose expansion
Participants receive nasoduodenal administration of XER-001 in combination with stereotactic body radiotherapy (SBRT).
Multiple visits for treatment and safety assessments during the treatment period
Trial Site Locations
Total: 4 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
CIty of Hope
Irvine, California, United States, 92618
Actively Recruiting
3
Christus St. Vincent Regional Cancer Center
Santa Fe, New Mexico, United States, 87505
Actively Recruiting
4
Oncology Consultants, P.A.
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
R
Robbin Frnka
J
Jeanne Jones
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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