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

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: Recruiting
• Conditions: Pancreatic Adenocarcinoma Non-resectable
• Intervention / Treatment: Combination product: ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003)

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Nancy A Sacco, PhD; Phone Number: 847-345-3931; Email: nsacco@continuitybiosciences.com
• Study Contact Backup: Name: Allison Marquette; Phone Number: 619-341-2232; Email: allison@continuitybiosciences.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting	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	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	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	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	Incidence of clinically significant abnormalities in 12-lead electrocardiograms (ECGs)	Screening through Week 20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose	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	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	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	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	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	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	Plasma PK of gemcitabine pre- and post-dose as measured by clearance (CL)	Screening through Week 8

Collaborators and Investigators

• Sponsor: Continuity Biosciences, LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pancreatic Cancer; Solid Tumor; Non-resectable Tumor
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Gemcitabine
• Other Study ID 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