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

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [1]

Active Indication

Abdominal NeoplasmsPancreatic Ductal AdenocarcinomaNeuroblastoma+ [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

/ CompletedPhase 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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27

Literatures (Medical) associated with CEB-01

01 Aug 2026·ANNALS OF SURGICAL ONCOLOGY

ASO Author Reflections: Preventing Local Recurrence After Surgery in Retroperitoneal Sarcoma with CEB-01, a SN-38-Releasing Membrane

Article

Author: Gonzalez, José Antonio ; Sebio, Ana

01 Aug 2026·ANNALS OF SURGICAL ONCOLOGY

First-in-Human Study of CEB-01: Novel Loco-Regional SN-38-Releasing Membrane to Prevent Local Recurrence in Retroperitoneal Sarcomas

Article

Author: Lopera de Llanos, Ester ; Gruber, Ann-Kathrin ; Huguet Ninou, Anna ; Orbis Castellanos, Juan Francisco ; Rodríguez Conde, Nivardo ; Villarejo-Campos, Pedro ; Hindi, Nadia ; López Andújar, Rafael ; Martin-Broto, Javier ; Colom Codina, Helena ; Gonzalez, José Antonio ; Sebio, Ana ; Serrano, César ; Díaz-Beveridge, Roberto ; Jiménez, Montiel ; Krauel, Lucas ; Álvarez Álvarez, Rosa ; Tornero García, José Antonio ; Pérez Campos, Antonio ; López Pousa, Antonio ; Castro Boix, Sandra ; Asencio, Jose Manuel

BACKGROUND:

Retroperitoneal sarcoma (RPS) resection remains challenging, with up to 50% of patients developing local recurrence and a 5-year survival rate of 50%. CEB-01, designed for local and controlled SN-38 delivery postresection, may increase local control and survival rates.

MATERIALS AND METHODS:

CEB-01 is a first-in-human, multicenter trial following a 3+3 dose escalation design and expansion cohort conducted in six centers in Spain. CEB-01 was implanted at three dose levels of SN-38: 9, 18, and 36 mg. The objectives were to establish the recommended phase 2 dose (RP2D) and evaluate its safety, efficacy, and pharmacokinetics.

RESULTS:

From July 2020 to November 2023, 14 patients were included: 10 males, with a median age of 63 years (range: 40-76), mostly with dedifferentiated (50%) and well-differentiated liposarcoma (35.7%), and R0 (79%) and R1 (21%) postsurgical margins. No dose-limiting toxicities were observed, and the RP2D was set at 18 mg. With a median follow-up of 9.1 months (range: 1-21), all patients at RP2D were recurrence-free and alive. Grade ≥ 3 adverse events were reported in just one patient treated with RP2D. The pharmacokinetic profile of SN-38 showed substantially lower C_max (20-70-fold) and longer elimination half-life times than those of intravenous irinotecan at clinically relevant doses. CEB-01 showed prolonged release of SN-38, which was detectable after 28 days in circulating blood.

CONCLUSIONS:

CEB-01 at 18 mg exhibited a tolerable safety profile and preliminary efficacy against postsurgery recurrence in patients with RPS. These results warrant further clinical investigations of this type of tumor. Clinical trial identification: EU CT: 2024-516971-34-00; clinicaltrials.gov: NCT04619056.

01 Aug 2026·ANNALS OF SURGICAL ONCOLOGY

ASO Visual Abstract: First-in-Human Study of CEB-01: Novel Loco-Regional SN-38-Releasing Membrane to Prevent Local Recurrence in Retroperitoneal Sarcomas

Article

Author: Lopera de Llanos, Ester ; Gruber, Ann-Kathrin ; Huguet Ninou, Anna ; Orbis Castellanos, Juan Francisco ; Rodríguez Conde, Nivardo ; Villarejo-Campos, Pedro ; Hindi, Nadia ; López Andújar, Rafael ; Martin-Broto, Javier ; Colom Codina, Helena ; Gonzalez, José Antonio ; Sebio, Ana ; Jiménez, Montiel ; Díaz-Beveridge, Roberto ; Serrano, César ; Krauel, Lucas ; Álvarez Álvarez, Rosa ; Tornero García, José Antonio ; Pérez Campos, Antonio ; López Pousa, Antonio ; Asencio, Jose Manuel ; Castro Boix, Sandra

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
Neuroblastoma	Phase 2	Spain	Cebiotex SL	-
Ewing Sarcoma	Phase 1	Spain	Cebiotex SL	03 Jun 2020
Locally Advanced Soft Tissue Sarcoma	Phase 1	Spain	Cebiotex SL	03 Jun 2020

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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	wfozbmqxbs(hrjxuklxuw) = AEs consisted of one catheter infection and one hypomagnesemia, both grade 3. bwahytyklq (ngfhnzdjpz )	Positive	20 May 2021