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.

Part of paid clinical trials in Duarte, California.

Sponsor
Xerient Pharma
Study ID
NCT07157033
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced Pancreas Cancer
  • Locally Advanced Pancreatic Adenocarcinoma
  • Locally Advanced Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • XER-001 — DRUG
    XER-001 (Amifostine for nasoduodenal delivery)

Study Details

The purpose of this study is to assess the safety, tolerability and efficacy of XER-001 and identify a best dose for future studies.

Key Dates

Start date
Jan 1, 2026
Status verified
Aug 2025
Primary completion
Jul 31, 2029
Completion
Jul 31, 2034

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: XER-001 at increasing dose levels

Primary Outcome Measure

Safety Assessments [Dose Escalation] [ Time Frame: 18 Months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Andrew Fernandez
[email protected]
Percy Lee, MD (PRINCIPAL_INVESTIGATOR)
CIty of HopeIrvineCalifornia92618
Xanthia Fajardo
[email protected]
Percy Lee, MD (PRINCIPAL_INVESTIGATOR)
Christus St. Vincent Regional Cancer CenterSanta FeNew Mexico87505
Tamara Flys, PhD
[email protected]
Bryan Goss, MD (PRINCIPAL_INVESTIGATOR)
Oncology Consultants, P.A.HoustonTexas77030
Julio Peguero, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CACIty of Hope· Irvine, CAChristus St. Vincent Regional Cancer Center· Santa Fe, NMOncology Consultants, P.A.· Houston, TX

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