XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer
Public ClinicalTrials.gov record NCT04825288. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT04825288
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 76 participants
Conditions and interventions
Conditions
Interventions
- Phase I: XB2001 250 mg Biological
- Phase I: XB2001 500 mg Biological
- Phase I: XB2001 1000 mg Biological
- Phase II: XB2001 1000 mg Biological
- Phase II: Placebo Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 27, 2021 (Actual)
- Primary completion
- Oct 26, 2023 (Actual)
- Completion
- Jun 10, 2025 (Actual)
- Last update posted
- Aug 4, 2026
2021 – 2025
United States locations
- U.S. sites
- 30
- U.S. states
- 17
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Oncology Associates | Tucson | Arizona | 85711 | — |
| Disney Family Cancer Center at Providence St. Joseph Medical Center | Burbank | California | 91505 | — |
| TOI Clinical Research | Cerritos | California | 90703 | — |
| Providence St. Joseph Heritage - Fullerton, CA | Fullerton | California | 92835 | — |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92663 | — |
| Grand Valley Oncology | Grand Junction | Colorado | 81505 | — |
| Sarah Cannon - Florida Cancer Specialists | Lake Mary | Florida | 32746 | — |
| Mt. Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | — |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | — |
| Cleveland Clinic of Florida | Weston | Florida | 33331 | — |
| Goshen Center for Cancer Care | Goshen | Indiana | 46526 | — |
| Alliance for Multispecialty Research, LLC | Merriam | Kansas | 66204 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Revive Research - Farmington Hills | Farmington Hills | Michigan | 48334 | — |
| Revive Research - Sterling Heights | Sterling Heights | Michigan | 48126 | — |
| St. Vincent Frontier Cancer Center | Billings | Montana | 59102 | — |
| Summit Medical Group | Florham Park | New Jersey | 07932 | — |
| Stony Brook Cancer Center | Stony Brook | New York | 11794 | — |
| Montefiore Einstein Medical Center | The Bronx | New York | 10461 | — |
| Providence Portland | Portland | Oregon | 97213 | — |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| University of Tennessee Medical Center Cancer Institute | Knoxville | Tennessee | 37920 | — |
| Sarah Cannon - Tennessee Oncology | Nashville | Tennessee | 37203 | — |
| Vanderbilt University | Nashville | Tennessee | 37232 | — |
| Texas Oncology - Arlington | Arlington | Texas | 76012 | — |
| Mary Crowley Cancer Research | Dallas | Texas | 75230 | — |
| Community Cancer Trials of Utah | Ogden | Utah | 84405 | — |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | — |
| Bon Secours St. Francis Cancer Center | Midlothian | Virginia | 23114 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04825288, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 4, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04825288 live on ClinicalTrials.gov.