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Pegcetacoplan with mFOLFIRINOX for Metastatic Pancreatic Cancer

This study is testing a new combination treatment for metastatic pancreatic ductal adenocarcinoma (PDAC), which is pancreatic cancer that has spread. It combines pegcetacoplan with a standard chemotherapy called mFOLFIRINOX (oxaliplatin, irinotecan, leucovorin, and fluorouracil). Pegcetacoplan works by targeting a part of your immune system to help fight the cancer. The mFOLFIRINOX drugs work by damaging cancer cells. The study aims to find out how safe this combination is (Phase I) and if it shows early signs of shrinking tumors or slowing cancer growth (Phase II). You may be able to join if you are at least 18 years old, have confirmed metastatic PDAC, and meet certain health requirements like good blood counts. The study plans to enroll 35 participants.

Study design
This is a Phase I/II interventional study, meaning it tests a new treatment in two stages: first for safety, then for early signs of effectiveness. It plans to include 35 participants.
What's involved
You would undergo procedures like tumor biopsies, collection of fluid samples (ascites, pleural fluid, blood), and CT scans. The study will measure side effects up to 30 days after your last dose.
Compensation
Not stated in the trial record.
Follow-up
The study will track how long you live without your cancer getting worse (progression-free survival) from the start of treatment until disease progression, death, or your last assessment, which will be checked at 24 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07214298

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Roswell Park Cancer Institute
~35 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Biopsy ProcedureBiospecimen CollectionComputed TomographyFluorouracilIrinotecanLeucovorin Calcium

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment-related adverse events (AE) (Phase I)
Measured over Up to 30 days after last dose of study treatment
+1 more outcome measured

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma
Stage IV Pancreatic Cancer AJCC v8

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NCT07214298

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Roswell Park Cancer Institute

    Buffalo, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Christos Fountzilas · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute

Who to contact

Sarah Chatley, BS
[email protected]
716-845-4846
Email the study team

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Eligibility criteria

Inclusion

Histologically or cytologically confirmed metastatic PDAC
Age ≥ 18 years of age
Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
Absolute neutrophil count ≥ 1,500/uL
Platelets ≥ 100,000/uL
Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST)(serum oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x institutional ULN or \<=5 ULN in the presence of liver metastasis
Estimated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault equation)
Albumin ≥ 3 g/dL
Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present
All patients must either have available archival tumor tissue or undergo new tumor biopsy (if presence of a lesion that can be safely biopsied) before treatment initiation for correlative studies
Willing and able to self-administer pegcetacoplan (administration by caregiver will be allowed)
Willing to receive vaccination against Neisseria meningitidis and Streptococcus pneumoniae if not already vaccinated
Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Women of child-bearing potential taking part in this study should continue the use of birth control for 6 months after the last study treatment, and should not donate eggs during that timeframe
Male participants taking part in this study should continue the use of birth control for 3 months after the last study treatment, and should not donate sperm during that timeframe
Participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure

Exclusion

Previous chemotherapy for PDAC. Gemcitabine-based post- or pre-operative therapy is allowed provided that the last dose and or surgical resection was at least 6 months prior to the documentation of metastatic disease, whichever occurred last
Toxicities from prior treatment grade \> 1 with the exemption of alopecia and fatigue
Refractory ascites or pleural effusion (requiring para- or thoracentesis weekly or more frequently or use of indwelling catheter for palliation)
Untreated bowel or gastric outlet obstruction; patients with ≤ 6 weeks from such an event who are adequately palliated are allowed to participate
Participants with known untreated brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Patients with major arterial thromboembolism (ATE) (coronary, cerebral, extremity or splanchnic) or venous thromboembolism (VTE) (pulmonary embolism or deep venous thrombosis) within 6 months from initiation of study treatment are not eligible for participation
Pregnant or nursing female participants
Unwilling or unable to follow protocol requirements
Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug

What this trial measures

  • Incidence of treatment-related adverse events (AE) (Phase I)Up to 30 days after last dose of study treatment

    Will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 criteria. Will be defined as any grade 3 or higher AE possibly, or definitely related to pegcetacoplan only. Will be summarized as the proportion of evaluable patients with 95% Clopper-Pearson confidence interval.

  • Progression-free survival (Phase II)From treatment initiation until disease progression, death or last disease assessment, assessed at 24 weeks