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.

NCT07157033 | Recruiting Phase 1 FDA Drug

• 1 other identifier: XER-201
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Locally Advanced Pancreatic Ductal Adenocarcinoma; Locally Advanced Pancreatic Adenocarcinoma; Locally Advanced Pancreas Cancer

Keywords

locally advanced pancreatic cancer; pancreatic cancer; locally advanced pancreatic adenocarcinoma; SBRT; amifostine

Outcome Measures

Primary Outcomes (6)

• Safety Assessments [Dose Escalation]

  Incidence of Dose Limiting Toxicities (DLTs) in DLT-evaluable subjects

  18 Months

• Safety Assessments [Dose Escalation]

  Identify the maximum tolerated dose and the RP2D

  18 Months

• Safety Assessments [Dose escalation and Dose Expansion]

  Number of participants with Serious Adverse Events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0

  40 months

• Safety Assessments [Dose Escalation and Dose Expansion]

  Number of participants with Treatment-related Adverse Events (AEs) graded per NCI-CTCAE version 5.0

  40 Months

• Safety Assessments [Dose Escalation and Dose Expansion]

  Number of participants with Treatment-Emergent AEs (TEAEs) graded per NCI-CTCAE version 5.0

  40 Months

• Safety Assessments [Dose Escalation and Dose Expansion]

  Gastrointestinal toxicity related to SBRT and LAPC

  40 Months

Secondary Outcomes (1)

• Antitumor Activity

  40 Months

Study Arms (1)

XER-001 at increasing dose levels

EXPERIMENTAL

Drug: XER-001

Interventions

XER-001 DRUG

XER-001 (Amifostine for nasoduodenal delivery)

XER-001 at increasing dose levels

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cytologic or biopsy confirmed adenocarcinoma of the pancreas
• Disease deemed amenable to definitive treatment with SBRT by being:
• Locally-advanced and/or technically unresectable, as determined by a specialist pancreaticobiliary surgeon and as part of a multidisciplinary team review including of multiphase cross-sectional imaging, demonstrating: i. Greater than 180-degree tumor involvement of the superior mesenteric artery (SMA) ii. Greater than 180-degree tumor involvement of the celiac axis including major branches of the celiac axis that would render the tumor unresectable (e.g. common hepatic artery) iii. Tumor involvement of the first branch of the SMA that is not surgically reconstructible iv. Long segment involvement of the superior mesenteric vein/portal vein/hepatic artery that is not amenable to surgical reconstructible.
• Potentially resectable anatomically but deemed not a surgical candidate after multidisciplinary review (such as unresectable due to comorbid conditions that render.
• the risks of surgery prohibitive)
• Potentially resectable but the patient elects to refuse surgery and prefers to pursue SBRT, and disease is deemed eligible for SBRT
• Primary tumor involvement abutment of the bowel is allowed, however bowel infiltration or invasion (identified endoscopically or by contrast enhanced imaging) is not allowed.
• No distant metastatic disease either prior to or following induction systemic therapy
• 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
• Patients must be able to understand and comply with any treatment related procedures for SBRT. including breath-hold techniques or tolerance of compression belt, or other motion management strategies for SBRT delivery.
• Age 18 years or older
• Eastern Cooperative Group (ECOG) performance status 0, 1, or 2
• Adequate hematologic function as indicated by:
• Absolute neutrophil counts \>/= 1500/mm3
• Hemaglobin \>/= 8.0 g/dL

You may not qualify if:

• Prior radiotherapy to the upper abdomen with overlap of. the anticipated SBRT field
• Prior radiopharmaceutical therapy
• Prior surgical resection of the pancreatic tumor
• Uncontrolled or active gastric or duodenal ulcer disease within 30 days of enrollment
• Visable invasion of tumor into the bowel/stomach.duodenal lumen on endoscopic evaluation
• Residual or ongoing grade 3+ non-hemotological toxicity from chemotherapy other than alopecia
• Uncontrolled intercurrent illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia
• Patients with history of myocardial infarction or unstable angina within 6 months prior to study enrollment
• Patients with history of symptomatic or (CTCAE-defined) grade 3+ hypocalcemia
• Patients with history of hypoparathyroidism
• Patients with history of hypertension where medical providers deem that interruption of antihypertensive regimen for one week is deemed unsafe.
• Patients with systolic blood pressure (BP) \< 100 or diastolic BP \< 65 at screening or baseline
• History or presence of a disease, such as hepatic impairment or renal insufficiency, that could affect the absorption, distribution, metabolism, or elimination of the investigational product, tolerance to radiotherapy, or could affect clinical or laboratory assessments.
• Patients with an estimated glomerular filtration rate of less than 30 mL per minute are excluded from the trial. Patients with total bilirubin greater than 2.5 mg/dL are excluded from the trial unless patient has history of Gilbert's syndrome. In case of suspected or confirmed Gilbert's syndrome, bilirubin will be fractionated, and patients with direct bilirubin greater than 1.5 mg/dL will be excluded from the trial.
• History of cardiac-related condition, which may include, but is not limited to, torsades de pointes, ventricular fibrillation, or ventricular tachycardia

Sponsors & Collaborators

• Xerient Pharma: lead

Study Sites (4)

City of Hope

Duarte, California, 91010, United States

RECRUITING

CIty of Hope

Irvine, California, 92618, United States

RECRUITING

Christus St. Vincent Regional Cancer Center

Santa Fe, New Mexico, 87505, United States

RECRUITING

Oncology Consultants, P.A.

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Robbin Frnka

CONTACT

2142055746; rfrnka@accelsobio.com

Jeanne Jones

CONTACT

jjones@accelsobio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2034
• Last Updated: May 1, 2026

Record last verified: 2025-08

Locations

US (4)