RecruitingPhase 1Phase 2NCT07214298

Pegcetacoplan in Combination With Modified FOLFIRINOX for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma

A Phase I/II Study of Complement Inhibition in Pancreatic Ductal Adenocarcinoma


Sponsor

Roswell Park Cancer Institute

Enrollment

35 participants

Start Date

Feb 16, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I/II trial tests the effect of pegcetacoplan in combination with oxaliplatin, irinotecan, leucovorin, and fluorouracil (mFOLFIRINOX) in treating patients with pancreatic ductal adenocarcinoma (PDAC) that has spread from where it first started (primary site) to other places in the body (metastatic). Pegcetacoplan works by targeting the immune complement process, a part of the immune system that defends against bacteria and may limit tumor progression and improve the immune system's response against tumor cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Leucovorin is a drug used to lessen the toxic effects of substances that block the action of folic acid. Leucovorin is a form of folic acid. It is a type of chemoprotective agent and a type of chemosensitizing agent. Fluorouracil stops cells from making DNA and it may kill tumor cells. It is a type of antimetabolite. Giving pegcetacoplan in combination with mFOLFIRINOX may be safe, tolerable, and/or effecting in treating patients with metastatic PDAC. This trial also evaluates the effect of pegcetacoplan on the incidence of major thrombotic events and the resulting complications. Thrombosis is a common complication in patients with PDAC. Thrombosis occurs when blood clots block veins or arteries. Complications of thrombosis, such as stroke or heart attack, can be life-threatening. Giving pegcetacoplan may help prevent blood clots from forming and decrease the risk of major thrombotic events.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called pegcetacoplan (a complement system inhibitor) to a standard chemotherapy regimen called modified FOLFIRINOX can improve outcomes for people with metastatic pancreatic cancer (cancer that has spread). **You may be eligible if...** - You are 18 or older and have confirmed metastatic pancreatic ductal adenocarcinoma (a specific type of pancreatic cancer) - You have not previously received chemotherapy for your metastatic pancreatic cancer (prior surgery with chemo is allowed if it was more than 6 months ago) - You are reasonably functional (ECOG 0 or 1) - Your blood counts, liver, and kidney function are adequate - You are willing and able to self-administer pegcetacoplan by injection - You are willing to receive certain vaccinations **You may NOT be eligible if...** - You have brain metastases - You have significant ongoing side effects from prior treatments - You have uncontrolled fluid buildup around the lungs or abdomen - You have had a major blood clot (heart attack, stroke, pulmonary embolism) within the past 6 months - 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

PROCEDUREBiopsy Procedure

Undergo tumor biopsy

PROCEDUREBiospecimen Collection

Undergo ascites, pleural fluid and blood sample collection

PROCEDUREComputed Tomography

Undergo CT

DRUGFluorouracil

Given IV

DRUGIrinotecan

Given IV

DRUGLeucovorin Calcium

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

DRUGOxaliplatin

Given IV

DRUGPegcetacoplan

Given IV and SC


Locations(1)

Roswell Park Cancer Institute

Buffalo, New York, United States

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NCT07214298


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