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RECRUITING Phase 1

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

NCT07214298 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • DRUG Fluorouracil
  • PROCEDURE Biopsy Procedure
  • DRUG Irinotecan

Study Locations (1)

New York

  • Roswell Park Cancer Institute — Buffalo

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2026-03-01
Est. Completion 2028-10-01
Phase Phase 1

Sponsor

Roswell Park Cancer Institute

228 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07214298

The ClinicalTrials.gov registry entry for NCT07214298 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Roswell Park Cancer Institute, which has 228 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Stage IV Pancreatic Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07214298 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07214298 about?

NCT07214298 is a clinical study titled "Pegcetacoplan in Combination With Modified FOLFIRINOX for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma". 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 (me...

What is the current status of trial NCT07214298?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2026-03-01. Estimated completion is 2028-10-01.

What conditions does trial NCT07214298 study?

This clinical trial studies the following conditions: Stage IV Pancreatic Cancer AJCC v8, Metastatic Pancreatic Ductal Adenocarcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07214298?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Fluorouracil (DRUG), Biopsy Procedure (PROCEDURE), Irinotecan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07214298?

This trial is sponsored by Roswell Park Cancer Institute, which has 228 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07214298 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial