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

1/2期已完成 NCT04825288

适应症	Pancreatic Cancer
分期	1/2期
申办方	XBiotech, Inc.
状态	已完成
受试者人数	76 人
干预（药物）	Phase I: XB2001 250 mg, Phase I: XB2001 500 mg, Phase I: XB2001 1000 mg, Phase II: XB2001 1000 mg, Phase II: Placebo
开始日期	2021年5月27日
完成日期	2023年10月26日
结果公布日	2026年8月4日

摘要

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

在 BENITIONS 中查看查看 ClinicalTrials.gov 原文

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全部试验

本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。

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