Recruiting
Phase 1

ACT-IOP-003

Sponsor:

Continuity Biosciences, LLC

Code:

NCT07481383

Conditions

Pancreatic Adenocarcinoma Non-resectable

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Pancreatic Adenocarcinoma Non-resectable

Study ID

NCT07481383

Start date

Mar 11, 2026

Status verified date

Jul, 2026

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

12 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1: ACT-IOP-003 Once Weekly

Gemcitabine treatment delivered via the ACT-IOP-003 study device once weekly for 8 weeks

experimental: Cohort 2: ACT-IOP-003 Twice Weekly

Gemcitabine treatment delivered via the ACT-IOP-003 study device twice weekly for 8 weeks

Interventions

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.

Primary outcome measure

  • Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting [ Time Frame: Screening through Week 20 ]
  • Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting [ Time Frame: Screening through Week 20 ]
  • Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting [ Time Frame: Screening through Week 20 ]
  • Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting [ Time Frame: Screening through Week 20 ]
  • Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting [ Time Frame: Screening through Week 20 ]

Central Contacts and Locations

Central contacts

Allison Marquette

619-341-2232allison@continuitybiosciences.com

Locations

University of Michigan Health

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Tina Jones Study Coordinator

734-615-3231tmhutch@med.umich.edu

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Nina M Clinical Research Specialist

304-293-2991nina.moore@hsc.wvu.edu

More Information

Sponsor

Continuity Biosciences, LLC

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • Pancreatic Cancer
  • Non-resectable Tumor
  • Solid Tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Continuity Biosciences, LLC on 2026-07-06.