NCT07224464

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.

Recruiting now NA Last updated 13 May 2026

What this trial tests

NA trial 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 Metastatic Solid Tumors in 12 participants. Currently enrolling.

Timeline

16 December 2025

Primary endpoint
1 December 2026

1 December 2030

Quick facts

Lead sponsor	New Phase Ltd.
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	device feasibility
Enrollment	12
Start date	16 December 2025
Primary completion	1 December 2026
Estimated completion	1 December 2030
Sites	1 location across United States

Drugs / interventions 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.

Conditions studied

• Metastatic Solid Tumors — all drugs for Metastatic Solid Tumors →
• Stage 4 Cancer — all drugs for Stage 4 Cancer →

Sponsor

New Phase Ltd.

Who can join

18 and older, any sex, with Metastatic Solid Tumors or Stage 4 Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.
  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
  Time frame: 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.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Integrating diagnosis and therapy in hepatocellular carcinoma: advances in nanotheranostics.
   Shen J, Wen Y, Wu S, Tian W. · · 2026 · PMID 41958834 · DOI 10.3389/fbioe.2026.1793834