RecruitingPhase 1NCT07481383

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

A First-in-Human, Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ACT Implantable Iontophoresis Chemotherapy Delivery Device With Gemcitabine (ACT-IOP-003) Once Weekly or Twice Weekly Following First-Line Systemic Chemotherapy in Participants With Nonresectable Pancreatic Cancer


Sponsor

Continuity Biosciences, LLC

Enrollment

12 participants

Start Date

Mar 11, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study is being done to find out if delivering gemcitabine using the ACT-IOP-003 device directly to the area where the tumor is in the pancreas is safe and tolerable. The main questions the study aims to answer are: * Is ACT-IOP-003 safe and tolerable when given to patients with nonmetastatic, locally advanced, nonresectable pancreatic cancer. * How much study drug (gemcitabine) is found in the blood before and after treatment. * If the tumor responds to treatment. * If the gemcitabine side effects are less than seen when delivered intravenously (IV). Study participants will: * Have the study device surgically placed on the pancreas at the beginning of the study. * Complete 8 weeks of treatment with a 4 week screening period and 12 weeks of follow-up for a total of 24 weeks of participation in the study. * Give blood, urine, and stool samples to monitor safety and determine how much of the study drug (gemcitabine) is in the blood. * Have imaging (CT) done at least three times during the study.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing a new implantable device that delivers chemotherapy (gemcitabine) directly into a pancreatic tumor using a process called iontophoresis — which uses a small electric current to push the drug into the tumor tissue. The goal is to deliver higher doses of chemotherapy right to the cancer while reducing side effects in the rest of the body. **You may be eligible if...** - You have been diagnosed with locally advanced pancreatic cancer that cannot be surgically removed (and has not spread to other organs) - Your cancer was confirmed as non-resectable during exploratory surgery - You have already received standard chemotherapy (FOLFIRINOX or Gem-Abraxane) for this diagnosis - You are in good physical condition (ECOG ≤ 1) **You may NOT be eligible if...** - You have severe or critical pancreatitis - You previously received radiation therapy for your pancreatic cancer - Your cancer has spread beyond the pancreas to other organs - You have a history of significant heart disease - You have metal implants in your body Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003)

The investigational product, ACT-IOP-003, is an ACT implantable iontophoresis chemotherapy delivery device that delivers gemcitabine directly to the pancreas instead of through intravenous (IV) infusion into the blood stream.


Locations(2)

University of Michigan Health

Ann Arbor, Michigan, United States

West Virginia University

Morgantown, West Virginia, United States

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NCT07481383


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