Locally Resectable Pediatrics TumorsPhase 2NCT06986811

CEB-01 in Pediatrics With Locally Resectable Abdominal Tumors

A Phase 2 study testing Standard surgery and CEB-01 in people with Locally Resectable Pediatrics Tumors, run by CEBIOTEX at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages Up to 18 years
Conditions the study is for: Locally Resectable Pediatrics Tumors
What is being tested?: Standard surgery and CEB-01
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteSpain
Study dates: 6 May 2025to May 2029
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

To be eligible to participate in this trial, an individual must meet all the following criteria:
≤ 18 years.
Participants must have a diagnosis of:
De novo or recurrent abdominal soft-tissue sarcoma.
De novo or recurrent high-risk neuroblastoma according to Children's Oncology Group (COG) risk classification, regardless of response to frontline therapy, diagnosed either by a former histologic verification of neuroblastoma and/or former demonstration of tumor cells in the bone marrow with increased urinary catecholamines at the time of study enrolment. Participants who were initially considered low or intermediate risk but were then reclassified as high risk are also eligible.
Other tumors: recurrent Wilms tumor, de novo or recurrent Germ cell tumour, de novo or recurrent extracranial malignant rhabdoid tumor, de novo or recurrent synovial sarcoma, de novo or recurrent fibrolamellar hepatocellular carcinoma, and de novo or recurrent desmoplastic small round cell tumor.

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A histology assessment is required for enrolment of de novo cases, except for patients with high-risk neuroblastoma for which a radioiodine-labelled meta-iodobenzyl-guanidine (MIBG) test is positive and excess of production od catecholamines is confirmed. A new histology assessment is not required for enrolment of the recurrent cases, it will be obtained from the resected tumor to assess whether the histology is identical to the original tumor.
Participants previously treated with irinotecan will be eligible if they have not had documented progressive disease during treatment.
Participants might have more than one surgically removable lesion.
Adequate liver, renal, hematological, and cardiac function as defined by biochemical and hematological parameters as follows: hemoglobin (Hb) >9.0 g/dL (with preoperative transfusion), platelets >80.000/mm3 with intraoperative transfusion, absolute neutrophil count ≥ 1.500/mm3 or below this threshold if there is clinical indication that the patient is on hematological recovery, albumin >3.0 g/dl, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 times the upper limit of normality [ULN], bilirubin <2 times the ULN, creatinine <1.0 mg/dl or creatinine clearance > 60 ml/min.
Participants must have fully recovered from the acute toxic clinically relevant effects (Grade 3 or above) of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this trial.
Lansky or Karnofsky functional performance status score ≥ 50 at screening.
Female participants of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at time of screening.
Female and male participants of childbearing potential must be willing to use adequate contraception throughout the study and for 6 months after surgery.
Life expectancy greater than 6 months.
The participant's legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained prior to any protocol screening procedures.

Who cannot join

An individual who meets any of the following criteria will be excluded from participation in this trial:
Metastatic lesions, that in the investigator's opinion will not jeopardize the assessment of efficacy and safety.
Other malignancies within past 2 years except for in-situ cancers or basal/squamous cell skin cancer. Subjects with other malignancies are eligible if they are disease-free for at least 24 months or have a clinically stable concurrent malignancy not requiring tumor-directed treatment.
Active bacterial, viral or fungal infection.
Known history of active human immunodeficiency virus (HIV) infection, hepatitis B, hepatitis C or chronic liver disease. Testing is not required in the absence of clinical findings or suspicion.
Impossibility of ensuring adequate follow-up.

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Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
Contraindication to computed tomography (CT) scan.
Major surgery within 14 days prior to the implant of study drug or still in recovery after experiencing surgical complications; neither tumor biopsy nor central line insertion are considered a major surgery.
Other relevant concomitant illnesses.
Participants´status post-allogeneic stem cell transplant are not eligible.
Participants with disease of any major organ system that would compromise their ability to withstand therapy.
Patients with tumor size requiring CEB-01 implant that exceeds the maximum implantable surface area based on Body Surface Area (BSA) correction.
Patients with known hypersensitivity to SN-38 or any of the CEB-01 excipients.
Pregnancy or lactation. Pregnant women are excluded from this study; if the patient is a lactating mother, breastfeeding should be discontinued.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, 08950

Other trials in Spain

About this study

Official title: First-in-pediatrics, 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 Pediatric Patients From Birth to Less Than 18 Years of Age With a Locally Resectable Tumors in Comparison to Standard of Care

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 tumor (WT), germ cell tumors (GCT), extracranial malignant rhabdoid tumor (eMRT), synovial sarcoma (SS), desmoplastic small round cell tumor (DSRCT) and fibrolamellar hepatocellular carcinoma (FL-HCC)

Read the detailed description

CEB-01-RLP01-CT trial is first-in-pediatrics, 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 pediatric patients from birth to less than 18 years of age with de novo or recurrent, locally resectable, abdominal tumors in comparison to standard of care.

The trial population will consist of 80 participants who fulfill all the inclusion and exclusion criteria, allocated in three cohorts:

Cohort 1: 20 participants with abdominal STS, open label treatment arm consisting of CEB-01 plus the standard of care (which may include surgery, with or without radiotherapy and/or chemotherapy). The outcomes will be compared to a well-matched population of about 10 participants from the same participating sites, including historical controls or contemporary controls.

Cohort 2: 20 participants with high-risk NB, open label treatment arm consisting of CEB-01 plus the standard of care (which may include surgery, with or without radiotherapy and/or chemotherapy). The outcomes will be compared to a well-matched population of about 10 participants from the same participating sites, including historical controls or contemporary controls.

Cohort 3: 20 participants with rare abdominal tumors including WT, GCT, eMRT, SS, DSRCT and FL-HCC, open label uncontrolled treatment arm to obtain additional safety and efficacy data.

For measurement of primary safety and efficacy endpoints, follow-up will consist of short-term evaluation at 365 ± 30 days and long-term evaluation at 1095 ± 30 days post-surgery as it is considered sufficient for the assessment of the therapeutic effect of CEB-01 regarding local recurrence.

For pharmacokinetic assessment, blood samples will be collected at baseline and at 9 different time points until 56 ± 4 days post-surgery.

For each participant the trial duration will be composed of a screening period for up to 28 days, one day for surgery and 1095 ± 30 days of follow-up.

A Data Safety Monitoring Board (DSMB) will review data in an unblinded fashion; details are given in the DSMB charter. The scheduled review will be performed by the DSMB once 10 treated participants have completed 6 months of follow-up. The DSMB can be convened at the request of the sponsor should safety signals be detected

Conditions: Locally Resectable Pediatrics Tumors
Being tested: Standard surgery, CEB-01
Keywords: CEB-01, SN-38, Locally resectable pediatrics tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard surgeryProcedure or surgery
The location and size of the tumor determine the type of surgery.
CEB-01Drug
It is novel formulation for local release of chemotherapy. It consists of a biocompatible and biodegradable nanofiber membrane made of poly(lactic-co-glycolic acid) (PLGA), which is loaded with the anti-tumor drug SN-38 and implanted in the surgical bed after tumor removal.

Study groups in NCT06986811
Study group	Role	What they receive
Standard surgery and CEB-01 implant after surgery	Experimental	Procedure/Surgery: Standard surgery The location and size of the tumor determine the type of surgery. Drug: CEB-01 It is novel formulation for local release of chemotherapy. It consists of a biocompatible and biodegradable nanofiber membrane made of poly(lactic-co-glycolic acid) (PLGA), which is loaded with the anti-tumor drug SN-38 and implanted in the surgical bed after tumor removal. Receives: Procedure: Standard surgery; Drug: CEB-01
Active Comparator: Arm 2 standard surgery	Active comparator	Procedure/Surgery: Standard surgery The location and size of the tumor determine the type of surgery. Receives: Procedure: Standard surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency of Adverse Events (AEs) (Safety)
Adverse Events (AE), serious and non-serious, with their frequency, severity, and relatedness to study drug and coded according to the most updated version of the Common Terminology Criteria for Adverse Events (CTCAE).
Measured: Through study completion, average 3 years

Secondary outcomes (9)

Progression-free survival (PFS)
Defined as the time from surgery to objective tumor progression or death from any cause.
Measured: Through study completion, average 3 years
Overall survival (OS).
Defined as time from surgery to death from any cause.
Measured: Through study completion, average 3 years
Local recurrence-free survival (LRFS)
Defined as the time from surgery until the progression of the disease in the area of implanted CEB-01.
Measured: Through study completion, average 3 years
New lesions either distant or metastatic by RECIST 1.1 (Response Evaluation Criteria in Solid Tumors, version 1.1)
Number of new lesions either distant or metastatic by RECIST 1.1. (Response Evaluation Criteria in Solid Tumors, version 1.1)
Measured: Through study completion, average 3 years
Area under the concentration-time curve (AUC0-inf) of SN-38 ( 7-ethyl-10-hydroxy Camptothecin)
Represents the total SN-38 (f 7-ethyl-10-hydroxy Camptothecin) exposure in the peripheral blood across time
Measured: During 60 days
Maximum concentration (Cmax) of SN-38.
The highest concentration of SN-38 in the peripheral blood samples taken at sequential timepoints
Measured: During 60 days
Time of maximum plasma concentration (Tmax) of SN38.
Time from the surgery to the moment with the highest concentration of SN-38 in the peripheral blood samples taken at sequential timepoints
Measured: During 60 days
Terminal half-life (t1/2) of SN-38
The time required for the plasma concentration of SN-38 to fall by 50% from the Cmax
Measured: During 60 days
Score of Quality of Life
Quality of Life Questionnaire (QoL) using KIDSCREEN-27
Measured: Through study completion, average 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 May 2025May 2029

First posted23 May 2025
Study start6 May 2025
Primary completionMay 2029 (estimated)
Study completionMay 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Locally Resectable Pediatrics TumorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: This is an exploratory, open label, arm CEB-01 plus standard of care (consisting of surgery with/without radiotherapy and/or chemotherapy, SOC), with external control arms, clinical trial in pediatric participants with locally resectable abdominal tumors (total 80 participants). 3 cohorts are included: Cohort 1 (20 participants): Abdominal STS. Treatment arm CEB-01 plus SOC. Cohort 2 (20 participants): High-risk NB.Treatment arm CEB-01 plus SOC. Cohorts 1 and 2 are each compared with \~10 external comparator patients (\~20 total), from the same participating sites, including historical control (e.g. within the last 10 years) or contemporary control (e.g. subjects that fulfill inclusion and exclusion criteria, but do not desire to receive experimental treatment) treated with SOC will be will be the external control Cohort 3 (20 participants): Abdominal tumors including WT, GCT, eMRT, SS, DSRCT and FL-HCC. Open-label and uncontrolled treatment arm to obtain safety and efficacy data.
Masking: None (open label)
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06986811
Sponsor's protocol ID: CEB-01-RLP01-CT
Other IDs: 2024-520054-38-00
Status last verified: Oct 2026
First submitted: 15 May 2025
Last updated: 20 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No individual participant data (IPD) will be provided.

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: First-in-pediatrics, 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 Pediatric Patients From Birth to Less Than 18 Years of Age With a Locally Resectable Tumors in Comparison to Standard of Care
ClinicalTrials.gov ID: NCT06986811
Acronym / sponsor ID: CEB-01-RLP01-CT
Conditions: Locally Resectable Pediatrics Tumors
Keywords: CEB-01, SN-38, Locally resectable pediatrics tumors
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 80 participants (estimated)
Lead sponsor: CEBIOTEXIndustry (pharma, biotech, devices)
Collaborators: CEBIOTEX S.L.
Study start: 6 May 2025 (actual)
Primary completion: May 2029 (estimated)
Study completion: May 2029 (estimated)
First posted: 23 May 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The trial population will consist of 80 participants who fulfill all the inclusion and exclusion criteria, allocated in three cohorts:

Cohort 3: 20 participants with rare abdominal tumors including WT, GCT, eMRT, SS, DSRCT and FL-HCC, open label uncontrolled treatment arm to obtain additional safety and efficacy data.

For pharmacokinetic assessment, blood samples will be collected at baseline and at 9 different time points until 56 ± 4 days post-surgery.

For each participant the trial duration will be composed of a screening period for up to 28 days, one day for surgery and 1095 ± 30 days of follow-up.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This is an exploratory, open label, arm CEB-01 plus standard of care (consisting of surgery with/without radiotherapy and/or chemotherapy, SOC), with external control arms, clinical trial in pediatric participants with locally resectable abdominal tumors (total 80 participants). 3 cohorts are included: Cohort 1 (20 participants): Abdominal STS. Treatment arm CEB-01 plus SOC. Cohort 2 (20 participants): High-risk NB.Treatment arm CEB-01 plus SOC. Cohorts 1 and 2 are each compared with ~10 external comparator patients (~20 total), from the same participating sites, including historical control (e.g. within the last 10 years) or contemporary control (e.g. subjects that fulfill inclusion and exclusion criteria, but do not desire to receive experimental treatment) treated with SOC will be will be the external control Cohort 3 (20 participants): Abdominal tumors including WT, GCT, eMRT, SS, DSRCT and FL-HCC. Open-label and uncontrolled treatment arm to obtain safety and efficacy data.

Arm	Type	Receives
Standard surgery and CEB-01 implant after surgery	Experimental	Procedure: Standard surgery, Drug: CEB-01Procedure/Surgery: Standard surgery The location and size of the tumor determine the type of surgery. Drug: CEB-01 It is novel formulation for local release of chemotherapy. It consists of a biocompatible and biodegradable nanofiber membrane made of poly(lactic-co-glycolic acid) (PLGA), which is loaded with the anti-tumor drug SN-38 and implanted in the surgical bed after tumor removal.
Active Comparator: Arm 2 standard surgery	Active comparator	Procedure: Standard surgeryProcedure/Surgery: Standard surgery The location and size of the tumor determine the type of surgery.

Who may qualify

Ages: Up to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (16 listed)

To be eligible to participate in this trial, an individual must meet all the following criteria:
≤ 18 years.
Participants must have a diagnosis of:
A histology assessment is required for enrolment of de novo cases, except for patients with high-risk neuroblastoma for which a radioiodine-labelled meta-iodobenzyl-guanidine (MIBG) test is positive and excess of production od catecholamines is confirmed. A new histology assessment is not required for enrolment of the recurrent cases, it will be obtained from the resected tumor to assess whether the histology is identical to the original tumor.
Participants previously treated with irinotecan will be eligible if they have not had documented progressive disease during treatment.

Key exclusion criteria (15 listed)

An individual who meets any of the following criteria will be excluded from participation in this trial:
Metastatic lesions, that in the investigator's opinion will not jeopardize the assessment of efficacy and safety.
Other malignancies within past 2 years except for in-situ cancers or basal/squamous cell skin cancer. Subjects with other malignancies are eligible if they are disease-free for at least 24 months or have a clinically stable concurrent malignancy not requiring tumor-directed treatment.
Active bacterial, viral or fungal infection.
Known history of active human immunodeficiency virus (HIV) infection, hepatitis B, hepatitis C or chronic liver disease. Testing is not required in the absence of clinical findings or suspicion.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Standard surgeryThe location and size of the tumor determine the type of surgery.	Procedure or surgery	Active Comparator: Arm 2 standard surgery, Standard surgery and CEB-01 implant after surgery
CEB-01It is novel formulation for local release of chemotherapy. It consists of a biocompatible and biodegradable nanofiber membrane made of poly(lactic-co-glycolic acid) (PLGA), which is loaded with the anti-tumor drug SN-38 and implanted in the surgical bed after tumor removal.	Drug	Standard surgery and CEB-01 implant after surgery

Primary outcome

Frequency of Adverse Events (AEs) (Safety)
Time frame: Through study completion, average 3 years
Adverse Events (AE), serious and non-serious, with their frequency, severity, and relatedness to study drug and coded according to the most updated version of the Common Terminology Criteria for Adverse Events (CTCAE).

9 secondary outcomes

Progression-free survival (PFS)
Time frame: Through study completion, average 3 years
Overall survival (OS).
Time frame: Through study completion, average 3 years
Local recurrence-free survival (LRFS)
Time frame: Through study completion, average 3 years
New lesions either distant or metastatic by RECIST 1.1 (Response Evaluation Criteria in Solid Tumors, version 1.1)
Time frame: Through study completion, average 3 years
Area under the concentration-time curve (AUC0-inf) of SN-38 ( 7-ethyl-10-hydroxy Camptothecin)
Time frame: During 60 days
Maximum concentration (Cmax) of SN-38.
Time frame: During 60 days
Time of maximum plasma concentration (Tmax) of SN38.
Time frame: During 60 days
Terminal half-life (t1/2) of SN-38
Time frame: During 60 days
Score of Quality of Life
Time frame: Through study completion, average 3 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
Individual participant dataSharing planned: No. No individual participant data (IPD) will be provided.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marta Pilar Martin Gimenez, M.D.; Ph.D. principal investigator

Hospital Sant Joan de Deu

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Standard surgery and CEB-01 in people with Locally Resectable Pediatrics Tumors, run by CEBIOTEX at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of Adverse Events (AEs) (Safety) (time frame: Through study completion, average 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06986811.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.