Could a new drug combo tame pancreatic cancer and prevent clots?
NCT ID NCT07214298
First seen Jun 24, 2026 · Last updated Aug 20, 2026 · Updated 3 times
Summary
This early-phase trial tests whether adding pegcetacoplan to standard chemotherapy (mFOLFIRINOX) is safe and effective for people with metastatic pancreatic cancer. Pegcetacoplan targets part of the immune system to possibly slow tumor growth and reduce blood clots, a common complication. About 35 adults with advanced pancreatic cancer will participate. The goal is to see if the combination improves survival and reduces clot-related risks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pegcetacoplan (a complement inhibitor) combined with mFOLFIRINOX chemotherapy (oxaliplatin, irinotecan, leucovorin, fluorouracil)
- What this could lead to
- If it works, this could lead to a more effective treatment for metastatic pancreatic cancer and help prevent dangerous blood clots.
- What could go wrong
- This is an early-phase trial with only 35 participants, so results may not apply to all patients. The combination may cause significant side effects, and the benefit is not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Roswell Park Cancer Institute
RECRUITINGBuffalo, New York, 14263, United States
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