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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

Who can join

Ages 18 and older · All sexes

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.

About the study

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.

What is being tested

• ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003) (combination product)

Sponsor: Continuity Biosciences, LLC · Participants: 12 · Started: Mar 11, 2026

Contact the study team

• Allison Marquette · Phone: 619-341-2232

Official record on ClinicalTrials.gov — NCT07481383

Locations in the U.S.

Conditions

• Pancreatic Cancer

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.