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An Implantable Device for Pancreatic Cancer Treatment

This study is testing a new way to deliver gemcitabine, a chemotherapy drug, directly to pancreatic tumors. Instead of an IV, an investigational device called ACT-IOP-003 is surgically placed on the pancreas to deliver gemcitabine. This is a "first-in-human" study, meaning it's the first time this device is being tested in people. Researchers want to see if this direct delivery method is safe and tolerable, how much gemcitabine gets into the bloodstream, if tumors respond, and if side effects are fewer than with traditional IV delivery. You may be eligible if you have non-metastatic (cancer that hasn't spread), non-resectable (can't be surgically removed) pancreatic adenocarcinoma and are at least 18 years old. The study plans to enroll 12 participants, but its current status is unclear.

Study design
This is a "first-in-human" interventional study, meaning it's the first time this device is being tested in people. It aims to enroll 12 participants.
What's involved
You would have the study device surgically placed on your pancreas at the beginning of the study. Safety and tolerability will be measured from screening through Week 20.
Compensation
Not stated in the trial record.
Follow-up
Safety and tolerability will be assessed from screening through Week 20.

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

NCT07481383

A First-in-Human Study to Evaluate Implantable Iontophoresis Chemotherapy Delivery Device With Gemcitabine Once Weekly or Twice Weekly in Participants With Pancreatic Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Continuity Biosciences, LLC
~12 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting
Measured over Screening through Week 20
+4 more outcomes measured

Conditions

Pancreatic Adenocarcinoma Non-resectable

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Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Michigan Health

    Ann Arbor, Michiganstudy coordinator listed

    Recruiting

  • West Virginia University

    Morgantown, West Virginiastudy 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.

Who to contact

Allison Marquette
[email protected]
619-341-2232
Email the study team

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Eligibility criteria

Inclusion

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
Diagnosis of nonmetastatic, nonresectable pancreatic adenocarcinoma as evident on initial study. screening computed tomography (CT) or magnetic resonance imaging (MRI) or previous scan within the last 12 weeks.
Initial diagnosis of borderline or locally advanced pancreatic adenocarcinoma confirmed as being nonresectable at the time of exploratory laparoscopic and/ or open surgery.
Previously received prior standard of care/neoadjuvant chemotherapy of FOLFIRINOX or GEM Abraxane for their current diagnosis of pancreatic cancer.

Exclusion

Current pancreatitis classified as severe or critical.
Prior radiation treatment as part of standard of care/neoadjuvant treatment for pancreatic cancer.
Evidence of metastatic pancreatic cancer or any other type of cancer upon screening of through CT/MRI.
Any medical history of past or present cardiovascular disease related to heart function.
Any metal implants.

What this trial measures

  • Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event ReportingScreening through Week 20

    Incidence of adverse events (AEs), serious adverse events (SAEs), drug- or device-related AEs, and dose-limiting toxicities (DLTs)

  • Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event ReportingScreening through Week 20

    Incidence of clinically significant abnormalities in physical examinations

  • Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event ReportingScreening through Week 20

    Incidence of clinically significant abnormalities in vital signs

  • Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event ReportingScreening through Week 20

    Incidence of clinically significant abnormalities in clinical laboratory tests (clinical chemistry, hematology, urinalysis)

  • Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event ReportingScreening through Week 20

    Incidence of clinically significant abnormalities in 12-lead electrocardiograms (ECGs)