Clinical Trial CEB-01-RLP01-CT

Phase 2, open-label, exploratory clinical trial evaluating CEB-01 in pediatric patients with locally resectable abdominal tumors.
The trial will assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of CEB-01 when used in addition to standard of care.

The trial will enroll up to 60 pediatric patients from 0 to 18 years of age, divided into three cohorts of 20 patients:

Patients with soft-tissue sarcoma (STS)
Patients with high-risk neuroblastoma (NB)
Patients with other rare abdominal tumors (such as Wilms’ tumor, germ cell tumors, extracranial malignant rhabdoid tumor, desmoplastic small round cell tumor, synovial sarcoma, fibrolamellar hepatocarcinoma)

Two of the cohorts (STS and NB) will have external control arms for comparison, of 20 patients each cohort.

The study will evaluate short-term and long-term safety (up to 3 years), as well as progression-free survival (PFS), overall survival (OS), local recurrence, and quality of life. Pharmacokinetic data on SN-38 will also be collected.

Active recruitment sites: Sant Joan de Déu (Barcelona). International patients are accepted for enrollment.

Recruitment period: Q2 2025 – Q2 2026
End of study: Q2 2029