Open Label Feasibility Dose Escalation Study to Evaluate the Safety of Sarah Nanotechnology System, With Alternating Magnetic Field (AMF) Application in Patients With Advanced Metastatic Solid Tumors.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Primary safety profile: assessing the number of device related adverse events and serious adverse events.
研究概览
简要总结
This is a sequential, dose-escalation, non-randomized, prospective, early feasibility trial. The goal of this clinical trial is to gather information on the safety and the recommended dose of the Sarah Nanotechnology System. Eligible participants have stage 4 metastatic solid tumor(s), that is(are) not responding to conventional treatment or have declined standard treatment options.
The main question it aims to answer is:
• What is the safety profile of the Sarah Nanotechnology System and which field strength and time of irradiation are safe for people?
Study participation involves:
- One intravenous injection (through a vein in the arm) of a solution that contains tiny particles (nanoparticles) containing iron oxide. The nanoparticles are delivered to the tumor(s) through blood circulation.
- About 4 hours after injection of the nanoparticles, participants are placed inside a machine (magnetic field system) where the upper torso will be exposed to low frequency (~300 kHz) alternating magnetic field (AMF) radiation. This type of radiation, unlike CT or X- rays, is non-ionizing. Non-ionizing means radiation that lacks the energy to remove electrons from an atom. Examples of devices that produce non-ionizing radiation are MRI machines, cell phones, Wi-Fi, microwave ovens, and sunlight.
The AMF heats up the iron oxide core in the nanoparticles, due to their magnetic properties, which in turn causes the temperature to increase within the tumor(s). Because cancer cells are more sensitive to heat than normal cells, the heat will damage the cancer cells potentially without harming the surrounding healthy tissues.
- During the treatment participants are covered by a cooling blanket to control body temperature, which will be monitored continuously throughout the procedure.
- Participants are followed up at 1 week and 1 month, and up to 5 years after the one-time treatment.
详细描述
This is a sequential, open-label, dose-escalation, non-randomized, prospective early feasibility clinical investigation designed to evaluate the safety of the Sarah Nanotechnology System, comprising intravenously administered Sarah Nanoparticles (SaNPs) in combination with a low-frequency Alternating Magnetic Field (AMF) generated by the Electromagnetic Induction System (EIS).
The purpose of the study is to assess the safety profile of the SaNP and AMF combination and to identify the recommended dose and irradiation parameters for a subsequent feasibility study. The study will also provide initial information regarding device performance and efficacy.
Scientific and Technical Background:
The Sarah Nanotechnology System utilizes controlled magnetic hyperthermia to thermally damage malignant cells while sparing surrounding healthy tissue. Following a single intravenous administration, SaNPs, nanoparticles with iron oxide core, circulate systemically and preferentially accumulate within tumor tissue through the Enhanced Permeability and Retention (EPR) effect, then participant's upper torso is exposed to an AMF (≈ 290 ± 10% kHz) by the EIS (Electromagnetic Induced System). The obtained effect is heating at tumor site.
Because AMF exposure can also induce eddy currents on the skin surface a patient cooling blanket system continuously helps regulating body surface temperature. Vital signs and skin temperature are monitored in real time throughout irradiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Device Feasibility
- 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
- •Life expectancy of at least 90 days.
- •Histologically confirmed advanced metastatic solid tumors located between the thoracic inlet and the pelvic floor, that have progressed on or after standard therapy and are ineligible for surgical resection or local therapies.
- •Must have measurable disease according to RECIST 1.
- •Locally advanced or metastatic disease which is not amenable to curative therapy and has progressed on or is intolerant to standard available therapy as deemed by the investigator.
- •There must be resolution of all systemic treatment-related adverse events. At least 14 days must have elapsed since the last systemic or radiotherapy treatment before screening visit.
- •Documented progressive disease confirmed by either CT (chest and abdomen), MRI or PET/CT scan since patient's last cancer therapy.
- •No prior history of brain metastasis confirmed by CT or MRI within 30 days prior to treatment.
- •Treatment planning CT scan performed within 14 days prior to study treatment.
- •Age ≥18 years.
- •Rib cage circumference ≤ 90 cm.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Patients should have sufficient organ and bone marrow function on screening day and on procedure day as defined below:
- •Leukocytes ≥3,000/mcL Absolute neutrophil count ≥1,500/mcL Platelets ≥100,000/mcL Total bilirubin ≤ 2.5 x limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤5 x institutional ULN Creatinine Glomerular filtration rate (GFR) ≥50 ml/min/1.73 m2 for patients with creatinine levels above institutional normal.
- •Ability to provide written informed consent document.
- •Confirmation that patient has no electronic or electronically conductive implants or metals:
- •Via a review of the CT scan
- •Metal questionnaire filled in by patients
排除标准
- •Received chemotherapy, radiotherapy or hormonal therapy within 14 days (before screening).
- •Received immunotherapy/biological therapy or any other investigational agent in the last 21 days (before screening).
- •Not yet recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1).
- •Presence of brain metastases or prior history of brain metastases (if no prior history, confirmed by CT or MRI within 30 days prior to treatment).
- •Known history of allergic reactions attributed to compounds of similar chemical or biological composition (For example: PEG 20,000 Dalton).
- •Uncontrolled intercurrent illness (including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, ischemia, or psychiatric illness) that in the opinion of the investigator would either limit compliance with study requirements or put participant at risk.
- •Pregnant and/or breastfeeding.
- •Unwilling to be abstinent or on contraception for up to 30 days after the last study treatment.
- •Presence of electronic or electronically conductive implants or metals in body (verified by screening CT and metal questionnaire).
- •Rib cage circumference over 90 cm.
- •Unable to provide written informed consent.
- •Unable to lay down with hands extended over head.
研究组 & 干预措施
Level 1
1.2 mg/kg of SaNP (Sarah nanoparticles) with 12-15 min of AMF irradiation
干预措施: The Sarah Nanotechnology System - intended to deliver thermal energy to malignant cells for the purpose of thermal destruction of these cells in patients with advanced metastatic solid tumors. (Device)
Level 2
1.2 mg/kg of SaNP (Sarah nanoparticles) with 16-20 min of AMF irradiation
干预措施: The Sarah Nanotechnology System - intended to deliver thermal energy to malignant cells for the purpose of thermal destruction of these cells in patients with advanced metastatic solid tumors. (Device)
Level 3
1.8 mg/kg of SaNP (Sarah nanoparticles) with 16-20 min of AMF
干预措施: The Sarah Nanotechnology System - intended to deliver thermal energy to malignant cells for the purpose of thermal destruction of these cells in patients with advanced metastatic solid tumors. (Device)
结局指标
主要结局
Primary safety profile: assessing the number of device related adverse events and serious adverse events.
时间窗: From treatment day and up to 1 month post treatment.
Evaluating the safety profile of the SaNP application via intravenous administration and the safety of the AMF radiation, in metastatic solid tumor patients, by assessing the procedural adverse events, and serious adverse events.
Primary safety of recommended dose: characterization of protocol dosing regimen
时间窗: From treatment day and up to 1 month post treatment.
Determining the recommended dose for the next efficacy study based on the different treatment arms.
次要结局
- Secondary - Initial efficacy evaluation: assessing clinical response according to RECIST 1.1(From treatment day and up to 1 month post treatment.)