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NCT04825288 · ClinicalTrials.gov record · last posted 2026-08-04

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

Study acronym: 1-BETTER
StatusCompleted
PhasePhase 1/2
Started2021-05-27
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from the ClinicalTrials.gov record
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).

Protocol amendment history 2 changes detected by DataLookout

2026-08-05
Trial completed
2026-08-05
Primary endpoint(s) modified
WasIncidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0, 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.
NowSafety and Tolerability of XB2001 in Combination With ONIVYDE + LV + 5-FU, 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.
Trial Details
NCT Number NCT04825288
Lead Sponsor XBiotech, Inc.
Conditions Pancreatic Cancer
Enrollment 76 participants
Start Date 2021-05-27
Primary Completion 2023-10-26 (estimated)
Study Completion 2025-06-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-04