Phase 1b Study to Test Safety and Drug Levels of Implantable Device Delivering Gemcitabine for Nonresectable Pancreatic Cancer After Chemotherapy

What this Trial Is About

Researchers are evaluating the safety and tolerability of delivering gemcitabine directly to the pancreas using an implantable iontophoresis chemotherapy device called ACT-IOP-003. This study focuses on patients with nonmetastatic, locally advanced, nonresectable pancreatic adenocarcinoma. The main goals are to assess device safety, drug levels in the blood before and after treatment, tumor response, and whether side effects are reduced compared to standard intravenous infusion. Participants will have the ACT-IOP-003 device surgically placed on their pancreas at the start of the study. They will receive gemcitabine treatment delivered through this device either once or twice weekly for 8 weeks. The study includes a 4-week screening period before treatment and a 12-week follow-up afterward, totaling 24 weeks of participation. During the study, participants will provide blood, urine, and stool samples to monitor safety and measure gemcitabine levels. Imaging scans, such as CT, will be performed at least three times to evaluate tumor response. Researchers will closely watch for adverse events to determine the maximum tolerated dose and overall safety throughout the study period.

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