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

Last updated: February 25, 2025
Sponsor: XBiotech, Inc.
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Digestive System Neoplasms

Pancreatic Cancer

Cancer

Treatment

XB2001 or Placebo

Clinical Study ID

NCT04825288
2020-PT049
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed pancreatic adenocarcinoma of exocrinepancreas that is metastatic, unresectable, or recurrent

  • At least one measurable lesion according to Response Evaluation Criteria in SolidTumor V1.1

  • Documented disease progression after one prior gemcitabine-based therapy OR oneFOLFIRINOX and gemcitabine combination therapy

  • Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1 or Karnofskyperformance status (KPS) ≥ 70

  • Adequate hepatic, renal and bone marrow function

Exclusion

Exclusion Criteria:

  • Clinically significant decrease in performance status (medical records) within 2weeks of intended first dose administration

  • Clinically significant GI disorders

  • Severe arterial thromboembolic events less than 6 months before inclusion

  • Prior Whole Brain Radiation Therapy (WBRT)

  • Evidence of brain metastases

  • NYHA Class III or IV congestive heart failure, ventricular arrhythmias oruncontrolled blood pressure (defined as ≥ 160/100 mm Hg)

  • Use of strong CYP3A4 inducers or inhibitors and/or UGT1A1 inhibitors within 14 daysprior to Visit 1/Baseline visit.

Study Design

Total Participants: 76
Treatment Group(s): 1
Primary Treatment: XB2001 or Placebo
Phase: 1/2
Study Start date:
May 27, 2021
Estimated Completion Date:
June 10, 2025

Study Description

Study 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

Sponsor: XBiotech USA, Inc.

Study Chair: David Park, M.D.

Sample Size: Approximately 69 patients will be enrolled in the USA (at least 9 patients in the open label phase 1 portion and 60 patients in the randomized phase 2 portion)

Approximate Duration:

This trial will include 2 phases. The first portion will be a Phase I, open label, dose escalation study evaluating the safety, tolerability and establishing the Maximum Tolerated Dose (MTD) of XB2001 in at least nine patients with metastatic pancreatic adenocarcinoma who are receiving ONIVYDE + Leucovorin l + d racemic + 5-Fluorouracil chemotherapy treatment. The duration for each patient in the Phase I portion will be 14 days (1 treatment cycle) in which they will be given one intravenous dose of XB2001 prior to receiving ONIVYDE + Leucovorin l + d racemic + 5-Fluorouracil chemotherapy treatment and assessed for Dose Limited Toxicities (DLT). The Phase II portion will be implemented following the completion of the Phase I portion and declaration of the MTD. The duration of subject participation in the randomized, double-blind, placebo-controlled Phase II portion of the trial is approximately 28 weeks: including a screening period of up to 30 days, and 24-week treatment period. All study subjects can continue treatment with XB2001 in an open label extension, for as long as they are judged to be benefitting clinically and have had no unacceptable toxicities.

Connect with a study center

  • Arizona Oncology Associates

    Tucson, Arizona 85711
    United States

    Site Not Available

  • Disney Family Cancer Center at Providence St. Joseph Medical Center

    Burbank, California 91505
    United States

    Site Not Available

  • TOI Clinical Research

    Cerritos, California 90703
    United States

    Site Not Available

  • Providence St. Joseph Heritage - Fullerton, CA

    Fullerton, California 92835
    United States

    Site Not Available

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California 92663
    United States

    Site Not Available

  • Grand Valley Oncology

    Grand Junction, Colorado 81505
    United States

    Site Not Available

  • Sarah Cannon - Florida Cancer Specialists

    Lake Mary, Florida 32746
    United States

    Site Not Available

  • Mt. Sinai Comprehensive Cancer Center

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • Sarasota Memorial Hospital

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Goshen Center for Cancer Care

    Goshen, Indiana 46526
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Merriam, Kansas 66204
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Revive Research - Farmington Hills

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Revive Research - Sterling Heights

    Sterling Heights, Michigan 48126
    United States

    Site Not Available

  • St. Vincent Frontier Cancer Center

    Billings, Montana 59102
    United States

    Site Not Available

  • Summit Medical Group

    Florham Park, New Jersey 07932
    United States

    Site Not Available

  • Montefiore Einstein Medical Center

    Bronx, New York 10461
    United States

    Site Not Available

  • Stony Brook Cancer Center

    Stony Brook, New York 11794
    United States

    Site Not Available

  • Providence Portland

    Portland, Oregon 97213
    United States

    Site Not Available

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • University of Tennessee Medical Center Cancer Institute

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Sarah Cannon - Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Vanderbilt University

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Mary Crowley Cancer Research

    Dallas, Texas 75230
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Community Cancer Trials of Utah

    Ogden, Utah 84405
    United States

    Site Not Available

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Bon Secours St. Francis Cancer Center

    Midlothian, Virginia 23114
    United States

    Site Not Available

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