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XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer
Sponsor: XBiotech, Inc.
Summary
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).
Official title: A Phase I/II Randomized, Double-blind, Placebo-controlled Trial (1-BETTER) Examining XB2001 (Anti-IL-1⍺ True Human Antibody) in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2021-05-27
Completion Date
2025-06-10
Last Updated
2026-08-04
Healthy Volunteers
No
Conditions
Interventions
Phase I: XB2001 250 mg
Subjects were administered one intravenous (IV) dose of XB2001 250 mg prior to receiving ONIVYDE 70 mg/m2 IV over 90 minutes, followed by leucovorin 400 mg/m2 IV over 30 minutes, followed by 5-Fluorouracil 2400 mg/m2 intravenously over 46 hours at each cycle.
Phase I: XB2001 500 mg
Subjects were administered one intravenous (IV) dose of XB2001 500 mg prior to receiving ONIVYDE 70 mg/m2 IV over 90 minutes, followed by leucovorin 400 mg/m2 IV over 30 minutes, followed by 5-Fluorouracil 2400 mg/m2 intravenously over 46 hours at each cycle.
Phase I: XB2001 1000 mg
Subjects were administered one intravenous (IV) dose of XB2001 1000 mg prior to receiving ONIVYDE 70 mg/m2 IV over 90 minutes, followed by leucovorin 400 mg/m2 IV over 30 minutes, followed by 5-Fluorouracil 2400 mg/m2 intravenously over 46 hours at each cycle.
Phase II: XB2001 1000 mg
Subjects were administered one intravenous (IV) dose of XB2001 1000 mg prior to receiving ONIVYDE 70 mg/m2 IV over 90 minutes, followed by leucovorin 400 mg/m2 IV over 30 minutes, followed by 5-Fluorouracil 2400 mg/m2 intravenously over 46 hours at each cycle.
Phase II: Placebo
Subjects were administered one intravenous (IV) dose of placebo 1000 mg prior to receiving ONIVYDE 70 mg/m2 IV over 90 minutes, followed by leucovorin 400 mg/m2 IV over 30 minutes, followed by 5-Fluorouracil 2400 mg/m2 intravenously over 46 hours at each cycle.
Locations (30)
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