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NCT04825288 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Pancreatic Cancer, sponsored by XBiotech.

Active
Registry status
Phase 1
Development phase
76
Enrollment target
20
Study locations

NCT04825288 is a Phase 1 study of Pancreatic Cancer that is active but no longer recruiting, run by XBiotech. The registered enrollment target is 76 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT04825288, a Phase 1 study of Pancreatic Cancer, is active but no longer recruiting, sponsored by XBiotech.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
76 participants
Enrollment target
20
Study locations

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).

Conditions Studied

Pancreatic Cancer

Interventions

  • BIOLOGICAL XB2001 or Placebo

Study Locations (20)

California

  • Disney Family Cancer Center at Providence St. Joseph Medical Center - Burbank
  • TOI Clinical Research - Cerritos
  • Providence St. Joseph Heritage - Fullerton, CA - Fullerton
  • Hoag Memorial Hospital Presbyterian - Newport Beach

Florida

  • Sarah Cannon - Florida Cancer Specialists - Lake Mary
  • Mt. Sinai Comprehensive Cancer Center - Miami Beach
  • Sarasota Memorial Hospital - Sarasota

Michigan

  • Barbara Ann Karmanos Cancer Institute - Detroit
  • Revive Research - Farmington Hills - Farmington Hills
  • Revive Research - Sterling Heights - Sterling Heights

New York

  • Stony Brook Cancer Center - Stony Brook
  • Montefiore Einstein Medical Center - The Bronx

Arizona

  • Arizona Oncology Associates - Tucson

Colorado

  • Grand Valley Oncology - Grand Junction

Indiana

  • Goshen Center for Cancer Care - Goshen

Kansas

  • Alliance for Multispecialty Research, LLC - Merriam

Trial Details

FieldValue
Enrollment Target 76 participants
Start Date 2021-05-27
Est. Completion 2025-06-10
Phase Phase 1

Sponsor

XBiotech

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04825288

The ClinicalTrials.gov registry entry for NCT04825288 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (81% lower). The listed sponsor is XBiotech, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pancreatic Cancer appearing as the primary indexed condition, and to 1 intervention - of which XB2001 or Placebo is the first listed.

NCT04825288 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Michigan.

Frequently Asked Questions

What is clinical trial NCT04825288 about?

NCT04825288 is a clinical study titled "XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer". 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 patie...

What is the current status of trial NCT04825288?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2021-05-27. Estimated completion is 2025-06-10.

What conditions does trial NCT04825288 study?

This clinical trial studies the following conditions: Pancreatic Cancer.

What interventions are being tested in trial NCT04825288?

The interventions under investigation include: XB2001 or Placebo (BIOLOGICAL).

Who is sponsoring clinical trial NCT04825288?

This trial is sponsored by XBiotech, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04825288 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.