Delving into the Latest Updates on CEB-01 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

7-ethyl-10-hydroxy Camptothecin, N-38 loaded biodegradable nanofiber, SN 38 loaded biodegradable nanofiber

+ [2]

Target

Top I

Action

inhibitors

Mechanism

TOP1 inhibitors(DNA topoisomerase I inhibitors)

Therapeutic Areas

NeoplasmsOther DiseasesDigestive System Disorders+ [1]

Active Indication

Abdominal NeoplasmsPancreatic Ductal AdenocarcinomaLocally Advanced Soft Tissue Sarcoma+ [1]

Inactive Indication

Ewing Sarcoma

Originator Organization

Polytechnic University of Catalonia

Active Organization

Cebiotex SL

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

RegulationOrphan Drug (United States), Orphan Drug (European Union)

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First-in-paediatrics, Open Label, Exploratory, Externally Controlled Clinical Trial to Evaluate Safety, Efficacy and Pharmacokinetics of 7-ethyl-10-hydroxy Camptothecin (SN-38) Formulated as a Biocompatible Polymeric Nanofiber Membrane (CEB-01) for Treatment, in Addition to Standard of Care, of Paediatric Patients From Birth to Less Than 18 Years of Age With a Locally Resectable Tumours in Comparison to Standard of Care

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 abdominal 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 abdominal tumors after surgery, while keeping a tolerable toxicity profile.
The study aims to assess the safety, tolerability, pharmacokinetics, and efficacy of CEB-01 in pediatric patients with locally resectable abdominal tumors including Soft Tissue Sarcoma (STS), high-risk Neuroblastoma (NB), Wilms tumour (WT), germ cell tumors (GCT), extracranial malignant rhabdoid tumour (eMRT), synovial sarcoma (SS), desmoplastic small round cell tumour (DSRCT) and fibrolamellar hepatocellular carcinoma (FL-HCC

Start Date06 May 2025

Sponsor / Collaborator

Cebiotex SL

NCT06538857

/ RecruitingPhase 2

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

Start Date20 Aug 2024

Sponsor / Collaborator

Cebiotex SL

[+1]

NCT04619056

/ Active, not recruitingPhase 1

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.

Start Date03 Jun 2020

Sponsor / Collaborator

Cebiotex SL

100 Clinical Results associated with CEB-01

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100 Translational Medicine associated with CEB-01

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100 Patents (Medical) associated with CEB-01

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100 Deals associated with CEB-01

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Abdominal Neoplasms	Phase 2	Spain	Cebiotex SL	06 May 2025
Pancreatic Ductal Adenocarcinoma	Phase 2	Spain	Cebiotex SL	20 Aug 2024
Ewing Sarcoma	Phase 1	Spain	Cebiotex SL	03 Jun 2020
Locally Advanced Soft Tissue Sarcoma	Phase 1	Spain	Cebiotex SL	03 Jun 2020
Neuroblastoma	Phase 1	-	Cebiotex SL	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04619056 (ASCO 12021 \| ASCO 22021) Manual	Phase 1	Sarcoma	-	CEB-01	vufkuzbrqa(adakwdxifv) = AEs consisted of one catheter infection and one hypomagnesemia, both grade 3. kbdrcwltpa (foczuxyyai )	Positive	20 May 2021