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

July 2, 2026 updated by: Continuity Biosciences, LLC

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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Health
        • Contact:
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1: ACT-IOP-003 Once Weekly
Gemcitabine treatment delivered via the ACT-IOP-003 study device once weekly for 8 weeks
Combination product: ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003)
The investigational product, ACT-IOP-003, is an ACT implantable iontophoresis chemotherapy delivery device that delivers gemcitabine directly to the pancreas instead of through intravenous (IV) infusion into the blood stream.
Experimental: Cohort 2: ACT-IOP-003 Twice Weekly
Gemcitabine treatment delivered via the ACT-IOP-003 study device twice weekly for 8 weeks
Combination product: ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003)
The investigational product, ACT-IOP-003, is an ACT implantable iontophoresis chemotherapy delivery device that delivers gemcitabine directly to the pancreas instead of through intravenous (IV) infusion into the blood stream.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting
Time Frame: Screening through Week 20
Incidence of adverse events (AEs), serious adverse events (SAEs), drug- or device-related AEs, and dose-limiting toxicities (DLTs)
Screening through Week 20
Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting
Time Frame: Screening through Week 20
Incidence of clinically significant abnormalities in physical examinations
Screening through Week 20
Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting
Time Frame: Screening through Week 20
Incidence of clinically significant abnormalities in vital signs
Screening through Week 20
Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting
Time Frame: Screening through Week 20
Incidence of clinically significant abnormalities in clinical laboratory tests (clinical chemistry, hematology, urinalysis)
Screening through Week 20
Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting
Time Frame: Screening through Week 20
Incidence of clinically significant abnormalities in 12-lead electrocardiograms (ECGs)
Screening through Week 20

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose
Time Frame: Screening through Week 8
Plasma PK of gemcitabine pre- and post-dose as measured by Cmax
Screening through Week 8
Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose
Time Frame: Screening through Week 8
Plasma PK of gemcitabine pre- and post-dose as measured by tmax
Screening through Week 8
Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose
Time Frame: Screening through Week 8
Plasma PK of gemcitabine pre- and post-dose as measured by t1/2
Screening through Week 8
Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose
Time Frame: Screening through Week 8
Plasma PK of gemcitabine pre- and post-dose as measured by Vd
Screening through Week 8
Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose
Time Frame: Screening through Week 8
Plasma PK of gemcitabine pre- and post-dose as measured by AUC0-∞
Screening through Week 8
Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose
Time Frame: Screening through Week 8
Plasma PK of gemcitabine pre- and post-dose as measured by AUCτ
Screening through Week 8
Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose
Time Frame: Screening through Week 8
Plasma PK of gemcitabine pre- and post-dose as measured by clearance (CL)
Screening through Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Continuity Biosciences, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACT-IOP-003-CLN-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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