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Metastatic Solid TumorsNCT07224464

The Sarah Nanotechnology System for Treatment of Advanced Metastatic Solid Tumors Using Hyperthermia.

A study testing 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. in people with Metastatic Solid Tumors and Stage 4 Cancer, run by New Phase Ltd. at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Solid Tumors, Stage 4 Cancer
What is being tested?
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.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
16 Dec 2025to Dec 2030
Phase
Interventional
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

  • 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 1.1.
  • 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.
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  • 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 ≤2.
  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

New Phase Clinical Team contact

+972-3-6798687

clinicalstudy@newphase.co.il

United States1 site, 1 recruiting
  • Mayo Clinic

    Rochester, Minnesota, 55905

    Scott C Lester, M.D., lester.scott@mayo.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

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:

Read more
  • 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.
Read the detailed description

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.

Dose-Escalation Design:

The study follows a standard 3 + 3 sequential escalation design, once the recommended dose is identified, an expansion cohort will repeat it.

SaNP dose: 100% SaNP dose, calculated according to NOAEL. AMF parameters: 290 ± 10% kHz; total irradiation time up to 15 minutes in the first treatment cohort, increasing to 16-20 minutes at the next treatment cohort depending on safety review.

Dose-limiting toxicity (DLT) criteria and escalation rules follow standard early-phase device study methodology.

Treatment Procedure:

On the treatment day, participants undergo laboratory tests and ECG assessment before SaNP infusion. Approximately four hours post-infusion, participants are positioned within the EIS coil for AMF irradiation while covered by a cooling blanket, and analgesic administration per physician discretion. Skin surface and oral temperatures, vital signs, and participant comfort are continuously monitored. After irradiation, repeat laboratory and ECG evaluations are performed prior to discharge.

Follow-up assessments occur at 7 ± 2 days and 30 ± 5 days post-treatment and then every 3-6 months up to 5 years for long-term safety surveillance.

Adverse events (AEs) and serious adverse events (SAEs) will be documented and evaluated for severity and relatedness to device or procedure. Real-time safety oversight is performed by the investigator and sponsor medical monitor; the DSMB periodically reviews cumulative safety data and recommends escalation, expansion, or study termination.

Being tested
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.
Keywords
Advanced metastatic solid tumors, Stage 4 cancer, Stage 4 liver cancer, Stage 4 ovarian cancer, Stage 4 colon cancer, Stage 4 breast cancer, Stage 4 lung cancer, Stage 4 cervical cancer, Stage 4 cholangiocarcinoma, Hyperthermia, Metastatic Solid Tumors
Medical subject headings
Neoplasms, Liver Neoplasms, Ovarian Neoplasms, Colonic Neoplasms, Breast Neoplasms, Lung Neoplasms, Uterine Cervical Neoplasms, Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

    Also called Hyperthermia

    This intervention includes the use of intravenus injection of Sarah Nanoparticles (SaNP) containing iron oxide core, together with non-ionizing alternating magnetic field (AMF) radiation.

Study groups in NCT07224464
Study groupRoleWhat they receive
Level 1Experimental1.2 mg/kg of SaNP (Sarah nanoparticles) with 12-15 min of AMF irradiation
Receives: Device: 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.
Level 2Experimental1.2 mg/kg of SaNP (Sarah nanoparticles) with 16-20 min of AMF irradiation
Receives: Device: 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.
Level 3Experimental1.8 mg/kg of SaNP (Sarah nanoparticles) with 16-20 min of AMF
Receives: Device: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary safety profile: assessing the number of device related adverse events and serious adverse events.

    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.

    Measured: From treatment day and up to 1 month post treatment.

  2. Primary safety of recommended dose: characterization of protocol dosing regimen

    Determining the recommended dose for the next efficacy study based on the different treatment arms.

    Measured: From treatment day and up to 1 month post treatment.

Secondary outcomes (1)
  1. Secondary - Initial efficacy evaluation: assessing clinical response according to RECIST 1.1

    Assessing response to treatment with SaNP and AMF radiation in participants with solid tumors according to evaluation, 1 month post treatment, of dynamic changes in the irradiated volume compared to baseline CT, using RECIST 1.1.

    Measured: From treatment day and up to 1 month post treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2025
  2. Study start16 Dec 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

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 N/A
Primary purpose
Device feasibility
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07224464
Sponsor's protocol ID
CL-400-001
Status last verified
Feb 2026
First submitted
3 Nov 2025
Last updated
15 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: This is an early feasibility study, the data is very preliminary as the sponsor (New Phase) is looking for the recommended treatment protocol for the next study.

Questions about this trial

What is this clinical trial studying?

A study testing 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. in people with Metastatic Solid Tumors and Stage 4 Cancer, run by New Phase Ltd. at 1 site 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 17 inclusion and 12 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 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

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 New Phase Clinical Team (+972-3-6798687, clinicalstudy@newphase.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary safety profile: assessing the number of device related adverse events and serious adverse events. (time frame: From treatment day and up to 1 month post treatment.). The study lists 2 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 15 May 2026.

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