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Could a new drug combo tame pancreatic cancer and prevent clots?

NCT ID NCT07214298

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 35 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Roswell Park Cancer Institute

    RECRUITING

    Buffalo, New York, 14263, United States

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Other studies related to the condition(s) this trial covers.