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Study identifier: NCT04825288 Synced from ClinicalTrials.gov · August 05, 2026
● Completed

XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer

Condition: Pancreatic Cancer  ·  Sponsor: XBiotech, Inc.

PhasePhase 1/Phase 2
Planned participants76
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This trial will include 2 portions (phase 1 and phase 2). The first portion will be a Phase I, open label, dose escalation study to establish the maximum tolerated dose (MTD) of XB2001 as measured by Dose-Limiting Toxicity (DLT), in combination with ONIVYDE + LV + 5-FU chemotherapy regimen in patients with advanced pancreatic cancer and to determine the recommended dose for the subsequent Phase 2 study. The phase 2 portion will be implemented with the maximum established tolerated dose (MTD) of XB2001. The target enrollment in the phase 2 portion is 60 patients which will be randomized on a 1:1 basis to XB2001 plus ONIVYDE + LV + 5-FU (Arm 1) or placebo plus ONIVYDE + LV + 5-FU (Arm 2).

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

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Locations (30)

Arizona Oncology AssociatesTucson, Arizona, United States
Disney Family Cancer Center at Providence St. Joseph Medical CenterBurbank, California, United States
TOI Clinical ResearchCerritos, California, United States
Providence St. Joseph Heritage - Fullerton, CAFullerton, California, United States
Hoag Memorial Hospital PresbyterianNewport Beach, California, United States
Grand Valley OncologyGrand Junction, Colorado, United States
Sarah Cannon - Florida Cancer SpecialistsLake Mary, Florida, United States
Mt. Sinai Comprehensive Cancer CenterMiami Beach, Florida, United States
Sarasota Memorial HospitalSarasota, Florida, United States
Cleveland Clinic of FloridaWeston, Florida, United States
Goshen Center for Cancer CareGoshen, Indiana, United States
Alliance for Multispecialty Research, LLCMerriam, Kansas, United States

+ 18 more locations — full list on the registry record.

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