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

NCT07224464 | Recruiting DMC FDA Device

• 1 other identifier: CL-400-001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Metastatic Solid Tumors; Stage 4 Cancer

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

Outcome Measures

Primary Outcomes (2)

• 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.

  From treatment day and up to 1 month post treatment.

• 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.

  From treatment day and up to 1 month post treatment.

Secondary Outcomes (1)

• Secondary - Initial efficacy evaluation: assessing clinical response according to RECIST 1.1

  From treatment day and up to 1 month post treatment.

Study Arms (2)

Level 1

EXPERIMENTAL

1.2 mg/kg of SaNP (Sarah nanoparticles) with 12-15 min of AMF irradiation

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 2

EXPERIMENTAL

1.2 mg/kg of SaNP (Sarah nanoparticles) with 16-20 min of AMF irradiation

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.

Interventions

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

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.

Also known as: Hyperthermia

Level 1; Level 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patient has exhausted all standard treatment options.
• 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 ≤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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• New Phase Ltd.: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Liver Neoplasms; Ovarian Neoplasms; Colonic Neoplasms; Breast Neoplasms; Lung Neoplasms; Uterine Cervical Neoplasms; Cholangiocarcinoma; Hyperthermia

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Study Officials

• Scott C Lester, MD

  Mayo Clinic, Rochester, MN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

New Phase Clinical Team

CONTACT

+972-3-6798687; clinicalstudy@newphase.co.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 4, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)