Implantable iontophoresis device to deliver gemcitabine directly to pancreatic tumors
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
This trial will try an implantable iontophoresis device to deliver gemcitabine directly to the pancreas in people with locally advanced, nonresectable pancreatic cancer to see if it is safe and tolerable.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Continuity Biosciences, LLC Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Ann Arbor, Michigan and 1 other locations) |
| Trial ID | NCT07481383 on ClinicalTrials.gov |
What this trial studies
This first-in-human, phase 1 trial tests an implantable iontophoresis device (ACT-IOP-003) that is surgically placed on the pancreas to deliver gemcitabine once or twice weekly. Participants complete 4 weeks of screening, 8 weeks of treatment, and 12 weeks of follow-up, with serial blood, urine, and stool sampling and at least three CT scans to monitor safety, drug levels, and tumor response. The primary focus is safety, tolerability, and pharmacokinetics (gemcitabine concentrations before and after treatment), with secondary interest in tumor response and whether systemic side effects are reduced compared with intravenous delivery. Enrollment targets people with nonmetastatic, locally advanced, nonresectable pancreatic adenocarcinoma who have previously received standard neoadjuvant chemotherapy.
Who should consider this trial
Good fit: Ideal candidates are people with nonmetastatic, locally advanced, nonresectable pancreatic adenocarcinoma, ECOG performance status ≤1, confirmed nonresectable at exploratory surgery, and prior neoadjuvant chemotherapy such as FOLFIRINOX or gemcitabine/nab‑paclitaxel.
Not a fit: Patients with metastatic disease, prior radiation for this cancer, severe or critical pancreatitis, significant cardiovascular disease, or poor performance status are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could deliver higher drug concentrations to the tumor while reducing systemic chemotherapy side effects.
How similar studies have performed: This is a first-in-human application of an implantable iontophoresis device for pancreatic cancer, so comparable human data are limited and the approach is largely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ann Arbor, Michigan and 1 other locations
- University of Michigan Health — Ann Arbor, Michigan, United States (Recruiting)
- West Virginia University — Morgantown, West Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Nancy A Sacco, PhD
- Email: nsacco@continuitybiosciences.com
- Phone: 847-345-3931
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.