A First-in-Human Study to Evaluate Implantable Iontophoresis Chemotherapy Delivery Device With Gemcitabine Once Weekly or Twice Weekly in Participants With Pancreatic Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
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.
Sponsor: Continuity Biosciences, LLC
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
Ann Arbor
Morgantown
Source: ClinicalTrials.gov · NCT07481383 · last updated 2026-07-06