NCT07481383招募中1 期
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
Continuity Biosciences, LLC2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2026年3月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •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.
排除标准
- •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.
研究组 & 干预措施
Cohort 1: ACT-IOP-003 Once Weekly
Experimental
Gemcitabine treatment delivered via the ACT-IOP-003 study device once weekly for 8 weeks
干预措施: ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003) (Combination Product)
Cohort 2: ACT-IOP-003 Twice Weekly
Experimental
Gemcitabine treatment delivered via the ACT-IOP-003 study device twice weekly for 8 weeks
干预措施: ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003) (Combination Product)
结局指标
主要结局
Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting
时间窗: Screening through Week 20
Incidence of adverse events (AEs), serious adverse events (SAEs), drug- or device-related AEs, and dose-limiting toxicities (DLTs)
次要结局
- Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose(Screening through Week 8)
研究者
研究点 (2)
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