A First-in-Human Study to Evaluate Implantable Iontophoresis Chemotherapy Delivery Device With Ge… (NCT07481383) | Clinical Trial Compass
RecruitingPhase 1
A First-in-Human Study to Evaluate Implantable Iontophoresis Chemotherapy Delivery Device With Gemcitabine Once Weekly or Twice Weekly in Participants With Pancreatic Cancer
United States12 participantsStarted 2026-03-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Note: Other inclusion/exclusion criteria apply.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting
Timeframe: Screening through Week 20
2
Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting
Timeframe: Screening through Week 20
3
Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting
Timeframe: Screening through Week 20
4
Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting
Timeframe: Screening through Week 20
5
Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting