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

Phase 1/2 Completed NCT04825288

Condition	Pancreatic Cancer
Phase	Phase 1/2
Sponsor	XBiotech, Inc.
Status	Completed
Enrollment	76 participants
Interventions	Phase I: XB2001 250 mg, Phase I: XB2001 500 mg, Phase I: XB2001 1000 mg, Phase II: XB2001 1000 mg, Phase II: Placebo
Start date	May 27, 2021
Completion date	Oct 26, 2023
Results posted	Aug 4, 2026

Summary

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).

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.

28 days (consisting of the first two 14-day treatment cycles or the formal DLT observation window). · Participants

Phase I: XB2001 250 mg	0 Participants
Phase I: XB2001 500 mg	0 Participants
Phase I: XB2001 1000 mg	0 Participants
Phase II: XB2001 1000 mg	0 Participants
Phase II: Placebo 1000 mg	0 Participants

Safety and Tolerability of XB2001 in Combination With ONIVYDE + LV + 5-FU

From post-infusion visit 1(week 0) through visit 13 (week 24), which is two weeks after the last infusion. · Participants

Phase I: XB2001 250 mg	0 Participants
Phase I: XB2001 500 mg	0 Participants
Phase I: XB2001 1000 mg	0 Participants
Phase II: XB2001 1000 mg	32 Participants
Phase II: Placebo	32 Participants

Open in BENITIONS View on ClinicalTrials.gov

Other trials for this condition

Short Course Radiation Therapy With Proton or Photon Beam Capecitabine and Hydroxychloroqu — Massachusetts General Hospital
Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tum — National Cancer Institute (NCI)
Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanc — National Cancer Institute (NCI)
Testing the Addition of an Anti-cancer Drug, Elimusertib (BAY 1895344) ATR Inhibitor, to t — National Cancer Institute (NCI)
Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced Poo — ECOG-ACRIN Cancer Research Group
A Phase 2 Trial of High-dose Ascorbate for Pancreatic Cancer (PACMAN 2.1) — University of Iowa

All trials

This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.

English 한국어 日本語中文 Русский