NCT07481383 A First-in-Human Study to Evaluate Implantable Iontophoresis Chemotherapy Delivery Device With Gemcitabine Once Weekly or Twice Weekly in Participants With Pancreatic Cancer
| NCT ID | NCT07481383 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Continuity Biosciences, LLC |
| Condition | Pancreatic Adenocarcinoma Non-resectable |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-03-11 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2026-03-11 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07481383 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Adenocarcinoma Non-resectable. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07481383 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07481383 currently recruiting?
Yes, NCT07481383 is actively recruiting participants. Contact the research team at nsacco@continuitybiosciences.com for enrollment information.
Where is the NCT07481383 trial being conducted?
This trial is being conducted at Ann Arbor, United States, Morgantown, United States.
Who is sponsoring the NCT07481383 clinical trial?
NCT07481383 is sponsored by Continuity Biosciences, LLC. The trial plans to enroll 12 participants.