Clinical trialNCT04825288CompletedPhase 1/PHASE2Interventional

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

SponsorXBiotech, Inc.Enrollment76Pancreatic Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

David J Park
Providence St. Joseph Heritage
Study Chair
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

30 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Arizona Oncology Associates
Tucson, Arizona, United States
Disney Family Cancer Center at Providence St. Joseph Medical Center
Burbank, California, United States
Toi Clinical Research
Cerritos, California, United States
Providence St. Joseph Heritage - Fullerton, Ca
Fullerton, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Grand Valley Oncology
Grand Junction, Colorado, United States
Sarah Cannon - Florida Cancer Specialists
Lake Mary, Florida, United States
Mt. Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Cleveland Clinic of Florida
Weston, Florida, United States
Goshen Center for Cancer Care
Goshen, Indiana, United States
Alliance for Multispecialty Research, Llc
Merriam, Kansas, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Revive Research - Farmington Hills
Farmington Hills, Michigan, United States
Revive Research - Sterling Heights
Sterling Heights, Michigan, United States
St. Vincent Frontier Cancer Center
Billings, Montana, United States
Summit Medical Group
Florham Park, New Jersey, United States
Stony Brook Cancer Center
Stony Brook, New York, United States
Montefiore Einstein Medical Center
The Bronx, New York, United States
Providence Portland
Portland, Oregon, United States
Upmc Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
University of Tennessee Medical Center Cancer Institute
Knoxville, Tennessee, United States
Sarah Cannon - Tennessee Oncology
Nashville, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
Texas Oncology - Arlington
Arlington, Texas, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
Community Cancer Trials of Utah
Ogden, Utah, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Bon Secours St. Francis Cancer Center
Midlothian, Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Phase I: XB2001 1000 mgPhase I: XB2001 250 mgPhase I: XB2001 500 mgPhase II: PlaceboPhase II: XB2001 1000 mg

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 27 May 2021
Primary completion: 26 Oct 2023
Completion: 10 Jun 2025
Last update posted: 4 Aug 2026
Registered enrollment: 76
Registry id: NCT04825288

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.