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COMPLETED
NCT04619056
PHASE1

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

Sponsor: CEBIOTEX

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

21

Start Date

2020-06-03

Completion Date

2025-11-28

Last Updated

2026-05-12

Healthy Volunteers

No

Interventions

DRUG

CEB-01 membrane loaded with SN-38

CEB-01 is a polymeric drug with a delivery system loaded with SN-38, and will be placed in the surgical bed at the time of tumor resection.

Locations (5)

Hospital Universitario Vall d'Hebron

Barcelona, Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain

Fundación Jiménez Díaz

Madrid, Madrid, Spain

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, Spain