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Can a targeted antibody give pancreatic cancer chemo a boost?

NCT ID NCT04825288

Disease control Sponsor: XBiotech, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This trial is testing whether adding an experimental antibody called XB2001 to a standard chemotherapy regimen can help people with advanced pancreatic cancer. The study has two parts: first, it finds the safest dose of XB2001, then it compares the antibody plus chemo against a placebo plus chemo in about 60 patients. The goal is to see if the combination can slow cancer growth and improve outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
XB2001 (anti-IL-1⍺ true human antibody) added to a chemotherapy regimen of ONIVYDE, 5-FU, and leucovorin
What this could lead to
If it works, this could point toward a new combination treatment that slows the growth of advanced pancreatic cancer.
What could go wrong
This is an early-phase trial, so the added benefit is uncertain. The antibody could also increase side effects when combined with chemotherapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

76 people

The number who actually took part.

Started

May 2021

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically or cytologically confirmed pancreatic adenocarcinoma of exocrine pancreas that is metastatic, unresectable, or recurrent * At least one measurable lesion according to Response Evaluation Criteria in Solid Tumor V1.1 * Documented disease progression after one prior gemcitabine-based therapy OR one FOLFIRINOX and gemcitabine combination therapy * Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1 or Karnofsky performance status (KPS) ≥ 70 * Adequate hepatic, renal and bone marrow function Exclusion Criteria: * Clinically significant decrease in performance status (medical records) within 2 weeks 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 or uncontrolled blood pressure (defined as ≥ 160/100 mm Hg) * Use of strong CYP3A4 inducers or inhibitors and/or UGT1A1 inhibitors within 14 days prior to Visit 1/Baseline visit.

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Conditions

The condition(s) this trial relates to.

malignant pancreatic neoplasm pancreatic adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pancreatic cancer

Contacts and locations

Locations

  • Alliance for Multispecialty Research, LLC

    Merriam, Kansas, 66204, United States

  • Arizona Oncology Associates

    Tucson, Arizona, 85711, United States

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Bon Secours St. Francis Cancer Center

    Midlothian, Virginia, 23114, United States

  • Cleveland Clinic of Florida

    Weston, Florida, 33331, United States

  • Community Cancer Trials of Utah

    Ogden, Utah, 84405, United States

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

    Burbank, California, 91505, United States

  • Goshen Center for Cancer Care

    Goshen, Indiana, 46526, United States

  • Grand Valley Oncology

    Grand Junction, Colorado, 81505, United States

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663, United States

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230, United States

  • Montefiore Einstein Medical Center

    The Bronx, New York, 10461, United States

  • Mt. Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140, United States

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121, United States

  • Providence Portland

    Portland, Oregon, 97213, United States

  • Providence St. Joseph Heritage - Fullerton, CA

    Fullerton, California, 92835, United States

  • Revive Research - Farmington Hills

    Farmington Hills, Michigan, 48334, United States

  • Revive Research - Sterling Heights

    Sterling Heights, Michigan, 48126, United States

  • Sarah Cannon - Florida Cancer Specialists

    Lake Mary, Florida, 32746, United States

  • Sarah Cannon - Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239, United States

  • St. Vincent Frontier Cancer Center

    Billings, Montana, 59102, United States

  • Stony Brook Cancer Center

    Stony Brook, New York, 11794, United States

  • Summit Medical Group

    Florham Park, New Jersey, 07932, United States

  • TOI Clinical Research

    Cerritos, California, 90703, United States

  • Texas Oncology - Arlington

    Arlington, Texas, 76012, United States

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Tennessee Medical Center Cancer Institute

    Knoxville, Tennessee, 37920, United States

  • Vanderbilt University

    Nashville, Tennessee, 37232, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

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