XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer
NCT ID: NCT04825288
Last Updated: 2025-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
76 participants
INTERVENTIONAL
2021-05-27
2025-06-10
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
XB2001 + ONIVYDE + 5-FU + LV combination therapy administered for 12 cycles of treatment
• Arm 1 Treatment Cycle: Patients randomized to this arm will receive the following treatments every 2 weeks: XB2001 MTD as an intravenous infusion over up to 60 minutes, followed by ONIVYDE 70 mg/m2 intravenously over 90 minutes, followed by leucovorin l + d racemic 400 mg/m2 intravenously over 30 minutes, followed by 5-Fluorouracil 2400mg/m2 intravenously over 46 hours. Therapy will be administered every 2 weeks (2 weeks = 1 cycle).
XB2001 or Placebo
XB2001 is a True Human monoclonal antibody that blocks the biological activity of IL-1α with a high degree of affinity and specificity. IL-1⍺ is a key mediator of inflammatory responses and is implicated in the pathophysiology of various diseases, including cancer, cardiovascular and rheumatologic diseases. Ample evidence supports targeting IL-1⍺ to block pathological inflammatory processes associated with many diseases.
Arm 2
Placebo + ONIVYDE + 5-FU + LV combination therapy administered for 12 cycles of treatment
• Arm 2 Treatment Cycle: Patients randomized to this arm will receive the following treatments every 2 weeks: Placebo as an intravenous infusion over up to 60 minutes, followed by ONIVYDE 70 mg/m2 intravenously over 90 minutes, followed by leucovorin l + d racemic 400 mg/m2 intravenously over 30 minutes, followed by 5-fluorouracil 2400 mg/m2 intravenously over 46 hours. Therapy will be administered every 2 weeks (2 weeks = 1 cycle).
XB2001 or Placebo
XB2001 is a True Human monoclonal antibody that blocks the biological activity of IL-1α with a high degree of affinity and specificity. IL-1⍺ is a key mediator of inflammatory responses and is implicated in the pathophysiology of various diseases, including cancer, cardiovascular and rheumatologic diseases. Ample evidence supports targeting IL-1⍺ to block pathological inflammatory processes associated with many diseases.
Interventions
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XB2001 or Placebo
XB2001 is a True Human monoclonal antibody that blocks the biological activity of IL-1α with a high degree of affinity and specificity. IL-1⍺ is a key mediator of inflammatory responses and is implicated in the pathophysiology of various diseases, including cancer, cardiovascular and rheumatologic diseases. Ample evidence supports targeting IL-1⍺ to block pathological inflammatory processes associated with many diseases.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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XBiotech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David J Park
Role: STUDY_CHAIR
Providence St. Joseph Heritage
Locations
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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
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
Mary Crowley Cancer Research
Dallas, Texas, United States
Community Cancer Trials of Utah
Ogden, Utah, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Bon Secours St. Francis Cancer Center
Midlothian, Virginia, United States
Countries
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Other Identifiers
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2020-PT049
Identifier Type: -
Identifier Source: org_study_id
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