NCT06538857

CEB-01 in Locally Resectable Pancreatic Cancer

Exploratory Clinical Trial to Assess Safety, Tolerability Efficacy and Pharmacokinetics of CEB-01 PLGA Membrane in Participants With Pancreatic Cancer.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: CEBIOTEX · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The CEB-01 implant is a membrane containing SN-38, the active metabolite of irinotecan, an already authorized chemotherapeutic agent. After surgical removal of the pancreatic cancer tumor, CEB 01 will be placed in the surgical bed for a local and sustained release of the chemotherapy. This is expected to delay or prevent local recurrence of pancreatic cancer after surgery, while keeping a tolerable toxicity profile. The study aims to assess the safety, tolerability, pharmacokinetics, and efficacy of CEB-01 in patients with locally resectable pancreatic cancer

Detailed description

Exploratory, multi-center, interventional, prospective, randomised, single-blind, controlled clinical trial in adult participants with locally resectable pancreatic cancer. Participants will be allocated in a 2:1 ratio to two treatment arms: (Arm 1) standard surgery and CEB-01 implant after surgery, or (Arm 2) standard surgery without implant. For measurement of primary safety and efficacy endpoints, follow-up will consist of shortterm evaluation at 365 ± 30 days and long-term evaluation at 1095 ± 30 days post-surgery as it is considered sufficient for the assessment of the therapeutic effect of CEB-01 regarding local recurrence. For pharmacokinetic assessment, blood samples will be collected at baseline and at 8 different time points until 43 ± 7 days post-surgery. For each participant the trial duration will be composed by a screening period for of up to 35 days, one day for surgery and 1095 ± 30 days of follow-up. The trial population will consist of 39 participants with a de novo pancreatic cancer who fulfil all the inclusion and exclusion criteria.

Conditions

• Pancreatic Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Standard surgery	The location and size of the tumor determine the type of surgery.
DRUG	CEB-01	It is novel formulation for local release of chemotherapy. It consists of a biocompatible and biodegradable nanofiber membrane made of poly(lactic-co-glycolic acid) (PLGA), which is loaded with the anti-tumor drug SN-38 and implanted in the surgical bed after tumor removal.

Timeline

• Start date: 2024-08-20
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2024-08-06
• Last updated: 2025-05-23

Locations

4 sites across 1 country: Spain