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NCT Number: 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

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.

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Key information

Conditions

Pancreatic Adenocarcinoma Non-resectable Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Michigan Health, Ann Arbor, Michigan, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Combination Product

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.

Primary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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)

  5. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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-∞

  6. 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

  7. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Allison Marquette

CONTACT

[email protected]

619-341-2232

Sponsors and collaborators

Lead sponsor

Continuity Biosciences, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 18, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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