Sarah Nanotechnology System for Cancer

Overseen By New Phase Clinical Team

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New Phase Ltd.

Disqualifiers: Brain metastases, Uncontrolled illness, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment using nanotechnology to target stage 4 metastatic solid tumors unresponsive to standard treatments. The goal is to determine the safety of this approach and identify the optimal dose for patients. Participants will receive tiny iron-containing particles through an IV and then be exposed to a special magnetic field to heat the tumor, potentially killing cancer cells without harming healthy tissue. Ideal candidates have tumors that haven't improved with other treatments and no history of brain metastasis. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in cancer treatment.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not have received chemotherapy, radiotherapy, or hormonal therapy within 14 days before screening, and immunotherapy or any investigational agent within 21 days before screening.

What prior data suggests that the Sarah Nanotechnology System is safe for treating cancer?

Research has shown that the Sarah Nanotechnology System is promising in early studies. In tests with mice, this treatment significantly improved survival rates compared to those not receiving it, suggesting potential effectiveness.

However, since this is an early trial, researchers are still collecting safety data in humans. The treatment uses tiny particles and a magnetic field to heat and target cancer cells, aiming to leave healthy tissue unharmed.

Although the treatment is designed to be safe, unknown side effects could still occur because it is early in testing. It uses a type of radiation generally safer than X-rays. During the procedure, researchers will monitor and control participants' body temperatures to ensure safety.

Overall, while early findings are encouraging, more data is needed to fully understand the treatment's safety in people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sarah Nanotechnology System for cancer treatment because it represents a novel approach using nanotechnology. Unlike traditional cancer treatments like chemotherapy or radiation, which can affect both healthy and cancerous cells, this system uses Sarah nanoparticles (SaNP) combined with alternating magnetic field (AMF) irradiation to target cancer cells more precisely. This method minimizes damage to surrounding healthy tissues, potentially reducing side effects. Additionally, the use of AMF irradiation at varying durations in the two treatment levels offers flexibility in customizing treatment intensity, which could enhance effectiveness and patient outcomes.

What evidence suggests that the Sarah Nanotechnology System might be an effective treatment for stage 4 metastatic solid tumors?

Research has shown that the Sarah Nanotechnology System uses tiny particles called nanoparticles to target tumors. In early studies on mice with breast cancer, these nanoparticles helped shrink tumors. They contain iron oxide, which heats up when exposed to a magnetic field, causing cancer cells to die from the heat. This method targets cancer cells while sparing healthy tissue. The goal is to exploit cancer cells' sensitivity to heat while protecting normal cells. Early results suggest this could offer a new treatment for cancers unresponsive to standard therapies. Participants in this trial will receive varying levels of AMF irradiation with the Sarah Nanotechnology System to evaluate its effectiveness and safety. ^{1 2 5 6 7}

Who Is on the Research Team?

Scott C Lester, MD

Principal Investigator

Mayo Clinic, Rochester, MN

Are You a Good Fit for This Trial?

This trial is for patients with stage 4 metastatic solid tumors, such as ovarian, colon, lung, bile duct, liver, breast, and cervical cancers. Participants must have tumors unresponsive to standard treatments or have declined conventional options.

Inclusion Criteria

Life expectancy of at least 90 days

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 and metal questionnaire filled in by patients

Exclusion Criteria

Known history of allergic reactions attributed to compounds of similar chemical or biological composition

Uncontrolled intercurrent illness that would limit compliance with study requirements or put participant at risk

Pregnant and/or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an intravenous injection of nanoparticles followed by exposure to an alternating magnetic field

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Visits at 1 week, 1 month, and every 3-6 months

What Are the Treatments Tested in This Trial?

Interventions

• Sarah Nanotechnology System

Trial Overview The Sarah Nanotechnology System is being tested for its safety and optimal dosage. It involves an intravenous injection of iron oxide nanoparticles followed by exposure to a non-ionizing alternating magnetic field designed to heat and destroy tumor cells.

How Is the Trial Designed?

Group I: Level 2 Experimental Treatment 1 Intervention

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

Group II: Level 1 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

New Phase Ltd.

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8602876/

Novel Nanoparticle-Based Cancer Treatment, Effectively ... The efficacy of Sarah Nanotechnology treatment was evaluated following 3 treatment cycles, in the murine 4T1 mCherry breast cancer metastatic ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07224464

NCT07224464 | Early Feasibility Study to Evaluate the ... The goal of this clinical trial is to gather information on the safety and the recommended dose of the Sarah Nanotechnology System. Eligible ...

3. newphase.co.il newphase.co.il/about/

About - New Phase Sarah Nanoparticles (SaNP)​​ Biocompatible nanoparticles designed to target and destroy malignant cells by inducing hyperthermic cell death without harming ...

4. biomedres.us biomedres.us/fulltexts/BJSTR.MS.ID.005254.php

Novel Approach for Magnetic Nanoparticle-based ... The efficacy of Sarah Nanotechnology treatment has been extensively evaluated by New Phase in pre-clinical studies, using the murine 4T1 breast ...

5. withpower.com withpower.com/trial/phase-ovarian-neoplasms-11-2025-2a320

Sarah Nanotechnology System for Cancer This trial is for patients with stage 4 metastatic solid tumors, such as ovarian, colon, lung, bile duct, liver, breast, and cervical cancers.

6. newphase.co.il newphase.co.il/

New Phase: The Sarah Nanotechnology System solution The Sarah Nanotechnology System new phase is a solution designed to treatmetastatic solid tumors of thermal energy to malignant cells.

7. app.trialscreen.org app.trialscreen.org/trials/early-feasibility-to-evaluate-safety-recommended-dose-sarah-nanotechnology-trial-nct07224464

The Sarah Nanotechnology System for Treatment of ... The treatment is designed to target cancer cells specifically while protecting healthy tissue. Risks: As this is an early safety study, unknown side effects may ...