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

NCT07481383 | Recruiting Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: ACT-IOP-003-CLN-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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

Keywords

Pancreatic Cancer; Non-resectable Tumor; Solid Tumor

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose

  Screening through Week 8

• Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose

  Screening through Week 8

• Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose

  Screening through Week 8

• Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose

  Screening through Week 8

• Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose

  Screening through Week 8

Study Arms (2)

Cohort 1: ACT-IOP-003 Once Weekly

EXPERIMENTAL

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)

Cohort 2: ACT-IOP-003 Twice Weekly

EXPERIMENTAL

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)

Interventions

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.

Cohort 1: ACT-IOP-003 Once Weekly; Cohort 2: ACT-IOP-003 Twice Weekly

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Continuity Biosciences, LLC: lead

Study Sites (2)

University of Michigan Health

Ann Arbor, Michigan, 48109, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, 26506, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Allison Marquette

CONTACT

619-341-2232; allison@continuitybiosciences.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 5 + 1 (modified 3 +3 design)

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 18, 2026
• Study Start: March 11, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)