CEB-01

CEB-01-RLP01-CT trial is 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 localy resectable abdominal tumours including neuroblastoma soft-tissue sarcoma, Wilms, germ cell tumours and other tumours, in comparison to standard of care.
Study treatment CEB-01: It is an investigational medicinal product consisting of a novel formulation for local release of chemotherapy. It is composed of a biocompatible and biodegradable nanofiber membrane poly(lactic-co-glycolic acid) (PLGA) which is loaded with the drug SN-38 (the main metabolite of irinotecan). The membrane is inert, non-toxic, and has shown efficacy in cell lines and xenograft models. In the preclinical setting, CEB-01 prevents relapse of surgically excised tumours and is based on a unique technology of biodegradable nanofibers, which can deliver anti-tumour SN-38 directly into the resected tumour bed. This targeted delivery thus eliminates remnant cancer cells after surgical procedures and effectively controls residual microscopic disease.
The potential benefit of a local treatment with CEB-01 to avoid local recurrence is highly supported by several animal models and a clinical trial in adults with de novo or recurrent STS, although the clinical experience, gathered so far, is limited.