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Clinical Trial NCT07481383 for Pancreatic Adenocarcinoma Non-resectable is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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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 Phase 1 12 First-in-Human
Clinical Trial NCT07481383 is designed to study Treatment for Pancreatic Adenocarcinoma Non-resectable. It is a Phase 1 interventional study that is recruiting, having started on 11 March 2026, with plans to enroll 12 participants. Led by Continuity Biosciences, LLC, it is expected to complete by 1 November 2027. The latest data from ClinicalTrials.gov was last updated on 18 March 2026.
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...
Official Title
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
Conditions
Pancreatic Adenocarcinoma Non-resectableOther Study IDs
- ACT-IOP-003-CLN-002
NCT ID Number
Start Date (Actual)
2026-03-11
Last Update Posted
2026-03-18
Completion Date (Estimated)
2027-11-01
Enrollment (Estimated)
12
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Keywords
Pancreatic Cancer
Non-resectable Tumor
Solid Tumor
Non-resectable Tumor
Solid Tumor
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalCohort 1: ACT-IOP-003 Once Weekly Gemcitabine treatment delivered via the ACT-IOP-003 study device once weekly for 8 weeks | 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. |
ExperimentalCohort 2: ACT-IOP-003 Twice Weekly Gemcitabine treatment delivered via the ACT-IOP-003 study device twice weekly for 8 weeks | 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 Measures
Secondary 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 |
| 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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.
Continuity Biosciences, LLCStudy Central Contact
Contact: Nancy A Sacco, PhD, 847-345-3931, [email protected]
Contact: Allison Marquette, 619-341-2232, [email protected]
1 Study Locations in 1 Countries
West Virginia
West Virginia University, Morgantown, West Virginia, 26506, United States
Study Coordinator, Contact
Recruiting