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

Continuity Biosciences, LLC

Status and phase: Enrolling; Phase 1

Conditions: Pancreatic Adenocarcinoma Non-resectable

Treatments: Combination Product: ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07481383

ACT-IOP-003-CLN-002

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Cohort 1: ACT-IOP-003 Once Weekly

Experimental group

Description:

Gemcitabine treatment delivered via the ACT-IOP-003 study device once weekly for 8 weeks

Treatment:

Combination Product: ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003)

Cohort 2: ACT-IOP-003 Twice Weekly

Experimental group

Description:

Gemcitabine treatment delivered via the ACT-IOP-003 study device twice weekly for 8 weeks

Treatment:

Combination Product: ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003)