Pancreatic Adenocarcinoma Non-resectablePhase 1NCT07481383
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 Phase 1 study testing ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003) in people with Pancreatic Adenocarcinoma Non-resectable, run by Continuity Biosciences, LLC at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma Non-resectable
- What is being tested?
- ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Mar 2026to 1 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Michigan Health
Ann Arbor, Michigan, 48109
Tina Jones Study Coordinator, 734-615-3231, tmhutch@med.umich.edu
- Recruiting
West Virginia University
Morgantown, West Virginia, 26506
Nina M Clinical Research Specialist, 304-293-2991, nina.moore@hsc.wvu.edu
About this study
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
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:
Read more
- 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
- Being tested
- ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003)
- Keywords
- Pancreatic Cancer, Non-resectable Tumor, Solid Tumor
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Cohort 1: ACT-IOP-003 Once Weekly | Experimental | Gemcitabine treatment delivered via the ACT-IOP-003 study device once weekly for 8 weeks Receives: 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 Receives: Combination Product: ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: Screening through Week 20
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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-∞
Measured: 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
Measured: 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)
Measured: Screening through Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start11 Mar 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Adenocarcinoma Non-resectableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 5 + 1 (modified 3 +3 design)
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Continuity Biosciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481383
- Sponsor's protocol ID
- ACT-IOP-003-CLN-002
- Status last verified
- Jul 2026
- First submitted
- 11 Mar 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07481383
- Acronym / sponsor ID
- ACT-IOP-003-CLN-002
- Conditions
- Pancreatic Adenocarcinoma Non-resectable
- Keywords
- Pancreatic Cancer, Non-resectable Tumor, Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Continuity Biosciences, LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 5 + 1 (modified 3 +3 design)
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: ACT-IOP-003 Once Weekly | Experimental | Combination Product: ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003)Gemcitabine treatment delivered via the ACT-IOP-003 study device once weekly for 8 weeks |
| Cohort 2: ACT-IOP-003 Twice Weekly | Experimental | Combination Product: ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003)Gemcitabine treatment delivered via the ACT-IOP-003 study device twice weekly for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | Cohort 1: ACT-IOP-003 Once Weekly, Cohort 2: ACT-IOP-003 Twice Weekly |
Primary outcome
Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting
Time frame: Screening through Week 20
Incidence of adverse events (AEs), serious adverse events (SAEs), drug- or device-related AEs, and dose-limiting toxicities (DLTs)
Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting
Time frame: Screening through Week 20
Incidence of clinically significant abnormalities in physical examinations
Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting
Time frame: Screening through Week 20
Incidence of clinically significant abnormalities in vital signs
Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting
Time frame: Screening through Week 20
Incidence of clinically significant abnormalities in clinical laboratory tests (clinical chemistry, hematology, urinalysis)
Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting
Time frame: Screening through Week 20
Incidence of clinically significant abnormalities in 12-lead electrocardiograms (ECGs)
7 secondary outcomes
Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose
Time frame: Screening through Week 8
Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose
Time frame: Screening through Week 8
Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose
Time frame: Screening through Week 8
Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose
Time frame: Screening through Week 8
Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose
Time frame: Screening through Week 8
Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose
Time frame: Screening through Week 8
Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose
Time frame: Screening through Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003) in people with Pancreatic Adenocarcinoma Non-resectable, run by Continuity Biosciences, LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allison Marquette (619-341-2232, allison@continuitybiosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting (time frame: Screening through Week 20). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.