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.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-520054-38-00

Acronym

CEB-01-RLP01-CT

Enrollment

Registered

2025-04-23

Start date

2025-05-06

Completion date

Unknown

Last updated

2025-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Desmoplastic small round cell tumour, Extracranial malignant rhabdoid tumour, Fibrolamellar hepatocellular carcinoma, Germ cell tumour, High-risk neuroblastoma, Soft-tissue sarcoma, Synovial sarcoma, Wilms tumour

Brief summary

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).

Detailed description

Progression-free survival (PFS)., Overall survival (OS)., Local recurrence-free survival (LRFS)., New lesions either distant or metastatic by RECIST 1.1., Paediatric Quality of Life Questionnaire (PedsQoL), Area under the concentration-time curve (AUC0-inf) of SN-38., Maximum concentration (Cmax) of SN-38., Time of maximum plasma concentration (Tmax) of SN-38., Terminal half-life (t1/2) of SN-38.

Interventions

None listed

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
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).	—

Secondary

Measure	Time frame
Progression-free survival (PFS)., Overall survival (OS)., Local recurrence-free survival (LRFS)., New lesions either distant or metastatic by RECIST 1.1., Paediatric Quality of Life Questionnaire (PedsQoL), Area under the concentration-time curve (AUC0-inf) of SN-38., Maximum concentration (Cmax) of SN-38., Time of maximum plasma concentration (Tmax) of SN-38., Terminal half-life (t1/2) of SN-38.	—

Countries

Spain

Outcome results