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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04825288.
Locations matching your search criteria
United States
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)Status: Active
Name Not Available
Study 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
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.
Lead OrganizationXBiotech, Inc.
