CEB-01(CEB-01) - 药物靶点：TOP1_在研适应症：胰腺癌，局部晚期软组织肉瘤，神经母细胞瘤_专利_临床

概要

基本信息

药物类型

小分子化药

别名

N-38 loaded biodegradable nanofiber、SN 38 loaded biodegradable nanofiber、CEB 01

+ [1]

靶点

TOP1

作用机制

TOP1抑制剂(DNA拓扑异构酶I抑制剂)

治疗领域

肿瘤其他疾病消化系统疾病+ [1]

在研适应症

胰腺癌局部晚期软组织肉瘤神经母细胞瘤

非在研适应症

尤文肉瘤

原研机构

Polytechnic University of Catalonia

在研机构

Cebiotex SL

非在研机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评孤儿药 (欧盟)、孤儿药 (美国)

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关联

2

项与 CEB-01 相关的临床试验

NCT06538857 / Recruiting临床2期

Exploratory Clinical Trial to Assess Safety, Tolerability Efficacy and Pharmacokinetics of CEB-01 PLGA Membrane in Participants with Pancreatic Cancer.

The CEB-01 implant is a membrane containing SN-38, the active metabolite of irinotecan, an already authorized chemotherapeutic agent. After surgical removal of the pancreatic cancer tumor, CEB 01 will be placed in the surgical bed for a local and sustained release of the chemotherapy. This is expected to delay or prevent local recurrence of pancreatic cancer after surgery, while keeping a tolerable toxicity profile.
The study aims to assess the safety, tolerability, pharmacokinetics, and efficacy of CEB-01 in patients with locally resectable pancreatic cancer

开始日期2024-08-09

申办/合作机构

Cebiotex SL

[+1]

NCT04619056 / Active, not recruiting临床1期

First-in-man Clinical Trial to Assess Safety and Tolerability of CEB-01 PLGA Membrane in Patients With Recurrent or Locally Advanced Retroperitoneal Soft Tissue Sarcoma After Surgery

This is an open label, first-in-man clinical trial to assess safety and tolerability of CEB-01 PLGA membrane in patients with recurrent or locally advanced retroperitoneal soft tissue sarcoma after surgery.
The trial will be conducted in 3 dose-escalation cohorts (3 patients each, enrolling patients one by one, after 4 weeks of observation and agreement of Scientific Committee and DMC) and in an expansion cohort, using the highest safe and tolerable dose. The study will follow a 3+3 modified design; dose escalation will follow a modified Fibonacci method. CEB-01 carrying a SN-38 dose between 9 and 36 mg will be placed in the surgical bed at the time of tumor resection.

开始日期2020-06-03

申办/合作机构

Cebiotex SL

100 项与 CEB-01 相关的临床结果

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100 项与 CEB-01 相关的转化医学

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100 项与 CEB-01 相关的专利（医药）

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100 项与 CEB-01 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
胰腺癌	临床2期	西班牙	Cebiotex SL	2024-08-09
尤文肉瘤	临床1期	西班牙	Cebiotex SL	2020-06-03
局部晚期软组织肉瘤	临床1期	西班牙	Cebiotex SL	2020-06-03
神经母细胞瘤	临床1期	-	Cebiotex SL	-

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04619056 (ASCO 12021 \| ASCO 22021) 人工标引	临床1期	肉瘤	-	CEB-01	築積艱構願網積餘簾鹹(廠餘繭願獵鬱鹹窪鏇餘) = AEs consisted of one catheter infection and one hypomagnesemia, both grade 3. 衊鏇積築構網廠顧願醖 (簾鏇製夢蓋衊憲衊遞遞 )	积极	2021-05-20