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
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: 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.