XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Pancreatic Cancer
In brief
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).
Key facts
- Study ID
- NCT04825288
- Run by
- XBiotech, Inc.
- People needed
- 76
- Starts
- 2021-05-27
- Expected to finish
- 2025-06-10
- Last updated by the study team
- 2026-08-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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