NCT04619056

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

Completed Phase 1 Last updated 19 February 2026

What this trial tests

Phase 1 trial testing CEB-01 membrane loaded with SN-38 in Locally Advanced Soft Tissue Sarcoma in 21 participants. Completed in 28 November 2025.

Timeline

3 June 2020

Primary endpoint
28 November 2025

28 November 2025

Quick facts

Lead sponsor	CEBIOTEX
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	3 June 2020
Primary completion	28 November 2025
Estimated completion	28 November 2025
Sites	5 locations across Spain

Drugs / interventions tested

• CEB-01 membrane loaded with SN-38 — full drug profile →

Conditions studied

• Locally Advanced Soft Tissue Sarcoma — all drugs for Locally Advanced Soft Tissue Sarcoma →
• Recurrent Soft Tissue Sarcoma — all drugs for Recurrent Soft Tissue Sarcoma →

Sponsor

CEBIOTEX — full company profile →

Who can join

18 and older, any sex, with Locally Advanced Soft Tissue Sarcoma or Recurrent Soft Tissue Sarcoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. PLGA-Based Nanomedicine: History of Advancement and Development in Clinical Applications of Multiple Diseases.
   Alsaab HO, Alharbi FD, Alhibs AS, Alanazi NB, et al · · 2022 · cited 141× · PMID 36559223 · DOI 10.3390/pharmaceutics14122728
2. Advances in PLGA-Based Drug Delivery Systems for Glioblastoma Treatment.
   Roy S, Alday D, Cai Q. · · 2025 · cited 1× · PMID 41497188 · DOI 10.2147/ijn.s563730
3. Synthetic Polymers for Drug, Gene, and Vaccine Delivery.
   Xu Y, Chen J, Ding J, Sun J, et al · · 2025 · PMID 42257193 · DOI 10.1021/polymscitech.5c00010
4. Tumor-Targeted Delivery Therapy Based on PLGA Nanoparticles.
   Wu F, Gao Y, Chi Y, Wang D, et al · · 2026 · PMID 42188374 · DOI 10.3390/jfb17050207
5. First-in-Human Study of CEB-01: Novel Loco-Regional SN-38-Releasing Membrane to Prevent Local Recurrence in Retroperitoneal Sarcomas.
   Gonzalez JA, Sebio A, Martin-Broto J, Hindi N, et al · · 2026 · PMID 41998462 · DOI 10.1245/s10434-026-19487-3