NCT07481383RecruitingPhase 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
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
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 11 Mar 2026
- Start date
- 11 Mar 2026
- Primary completion date
- 1 Aug 2027
- Lead sponsor
- Continuity Biosciences, LLC
- Diseases
- Pancreatic cancer
- NCT number
- NCT07481383
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 12
- From 11 Mar 2026 to the primary completion date, 1 Aug 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiation treatment as part of standard of care/neoadjuvant treatment for pancreatic cancer.
- Any metal implants.
- Note: Other inclusion/exclusion criteria apply.
Other illness
- 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.
Other
- Current pancreatitis classified as severe or critical.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Health Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| West Virginia University Coordinator of this site? Confirm its status | Morgantown | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.