RecruitingPhase 2NCT06538857

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.

Sponsor

CEBIOTEX

Enrollment

39 participants

Start Date

Aug 20, 2024

Study Type

INTERVENTIONAL

Conditions

Pancreatic Carcinoma

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called CEB-01 in people with pancreatic cancer that has not yet spread to other parts of the body and may be removed by surgery. The study wants to see if CEB-01 is safe and whether it can help shrink the tumor before or during surgery. **You may be eligible if...** - You are 18 or older with locally advanced pancreatic cancer that can potentially be surgically removed - Your cancer is confirmed by biopsy (a pre-surgery biopsy is not always required — it can be done during the operation) - You have at least one measurable tumor visible on imaging - If you have had prior chemotherapy, your cancer must not have progressed during that treatment **You may NOT be eligible if...** - Your cancer has spread widely beyond the pancreas - You do not meet safety requirements for organ function or overall health - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREStandard surgery

The location and size of the tumor determine the type of surgery.

DRUGCEB-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.

Locations(4)

Hospital Clínico y Provincial de Barcelona

Barcelona, Catalonia, Spain

H. Clínico San Carlos

Madrid, Madrid, Spain

H.U. Virgen del Rocío

Seville, Sevilla, Spain

H. Clínico Univ. de Valencia

Valencia, Valencia, Spain

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NCT06538857

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