First-in-man Clinical Trial of CEB-01 PLGA Membrane in Recurrent or Locally Advanced Retroperitoneal Soft Tissue Sarcoma

Summary

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.

Timeline

Start

2020-06-03

Primary completion

2025-11-28

Completion

2025-11-28

Publications

• Results Sebio A, Gonzalez JA. ASO Author Reflections: Preventing Local Recurrence After Surgery in Retroperitoneal Sarcoma with CEB-01, a SN-38-Releasing Membrane. Ann Surg Oncol. 2026 Apr 15. doi: 10.1245/s10434-026-19638-6. Online ahead of print. No abstract available.
• Results Gonzalez JA, Sebio A, Martin-Broto J, Hindi N, Villarejo-Campos P, Jimenez M, Diaz-Beveridge R, Orbis Castellanos JF, Lopez Andujar R, Alvarez Alvarez R, Asencio JM, Serrano C, Rodriguez Conde N, Castro Boix S, Krauel L, Colom Codina H, Tornero Garcia JA, Lopera de Llanos E, Huguet Ninou A, Perez Campos A, Gruber AK, Lopez Pousa A. ASO Visual Abstract: First-in-Human Study of CEB-01: Novel Loco-Regional SN-38-Releasing Membrane to Prevent Local Recurrence in Retroperitoneal Sarcomas. Ann Surg Oncol. 2026 Apr 15. doi: 10.1245/s10434-026-19614-0. Online ahead of print. No abstract available.
• Results Gonzalez JA, Sebio A, Martin-Broto J, Hindi N, Villarejo-Campos P, Jimenez M, Diaz-Beveridge R, Orbis Castellanos JF, Lopez Andujar R, Alvarez Alvarez R, Asencio JM, Serrano C, Rodriguez Conde N, Castro Boix S, Krauel L, Colom Codina H, Tornero Garcia JA, Lopera de Llanos E, Huguet Ninou A, Perez Campos A, Gruber AK, Lopez Pousa A. First-in-Human Study of CEB-01: Novel Loco-Regional SN-38-Releasing Membrane to Prevent Local Recurrence in Retroperitoneal Sarcomas. Ann Surg Oncol. 2026 Aug;33(8):7677-7687. doi: 10.1245/s10434-026-19487-3. Epub 2026 Apr 17.

Drugs

Indications