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 1RecruitingNCT07481383

Continuity Biosciences, LLC12 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Adenocarcinoma Non-resectable

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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)

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: Screening through Week 20