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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 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-05-01

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Continuity Biosciences, LLC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-11
Primary Completion
2027-08-01
Completion
2027-11-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07481383 on ClinicalTrials.gov