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