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

第1/2相完了 NCT04825288

対象疾患	Pancreatic Cancer
相	第1/2相
スポンサー	XBiotech, Inc.
ステータス	完了
参加者数	76 名
介入（薬剤）	Phase I: XB2001 250 mg, Phase I: XB2001 500 mg, Phase I: XB2001 1000 mg, Phase II: XB2001 1000 mg, Phase II: Placebo
開始日	2021年5月27日
完了日	2023年10月26日
結果公開日	2026年8月4日

概要

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

BENITIONS で見る ClinicalTrials.gov の原文を見る

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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

すべての治験

このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。

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