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

Conditions

• Pancreatic Adenocarcinoma Non-resectable

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Mar 11, 2026

Status verified

Apr 2026

Primary completion

Aug 1, 2027

Completion

Nov 1, 2027

Study Design

Enrollment

12 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

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

Primary Outcome Measure

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

Central Contacts

• Nancy A Sacco, PhD
  847-345-3931
  [email protected]
• Allison Marquette
  619-341-2232
  [email protected]

Locations (2)

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