Sarah Nanotechnology System treatment using magnetic hyperthermia for advanced metastatic solid tumors
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 trial will try a single IV dose of iron-oxide nanoparticles followed by a low-frequency magnetic field to heat tumors in people with stage 4 metastatic solid tumors who have exhausted standard treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 9 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | New Phase Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07224464 on ClinicalTrials.gov |
What this trial studies
This is an open-label, sequential dose-escalation early-feasibility trial testing intravenously delivered Sarah Nanoparticles (SaNPs) followed by exposure of the upper torso to a low-frequency alternating magnetic field (≈290 kHz) to generate controlled heating in tumor tissue. SaNPs are intended to accumulate in tumors via the enhanced permeability and retention effect, and the magnetic field induces localized hyperthermia to damage malignant cells while a cooling blanket and continuous monitoring manage skin temperature and vital signs. The study will escalate field strength and irradiation time to define a safety profile and identify recommended parameters for future feasibility work. Participants receive one SaNP infusion with imaging-confirmed measurable disease and are monitored for safety and preliminary device performance outcomes.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed stage 4 metastatic solid tumors between the thoracic inlet and pelvic floor, measurable by RECIST 1.1, who have progressed after or declined standard therapies and have life expectancy ≥90 days are ideal candidates.
Not a fit: Patients with brain metastases, tumors outside the treatment field, those eligible for effective standard therapies, or who cannot meet anatomical or safety limits (for example rib cage circumference >90 cm) are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could offer a new local-ablative treatment option for unresectable metastatic tumors with limited additional systemic toxicity.
How similar studies have performed: Prior, small clinical programs of magnetic nanoparticle hyperthermia have shown limited but promising local tumor control in certain indications, but the approach remains experimental for widespread metastatic disease.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Life expectancy of at least 90 days.
2. 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.
3. Must have measurable disease according to RECIST 1.1.
4. Patient has exhausted all standard treatment options.
5. 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.
6. Documented progressive disease confirmed by either CT (chest and abdomen), MRI or PET/CT scan since patient's last cancer therapy.
7. No prior history of brain metastasis confirmed by CT or MRI within 30 days prior to treatment.
8. Treatment planning CT scan performed within 14 days prior to study treatment.
9. Age ≥18 years.
10. Rib cage circumference ≤ 90 cm.
11. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
12. 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.
13. Ability to provide written informed consent document.
14. 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
Exclusion Criteria:
1. Received chemotherapy, radiotherapy or hormonal therapy within 14 days (before screening).
2. Received immunotherapy/biological therapy or any other investigational agent in the last 21 days (before screening).
3. Not yet recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1).
4. 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).
5. Known history of allergic reactions attributed to compounds of similar chemical or biological composition (For example: PEG 20,000 Dalton).
6. 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.
7. Pregnant and/or breastfeeding.
8. Unwilling to be abstinent or on contraception for up to 30 days after the last study treatment.
9. Presence of electronic or electronically conductive implants or metals in body (verified by screening CT and metal questionnaire).
10. Rib cage circumference over 90 cm.
11. Unable to provide written informed consent.
12. Unable to lay down with hands extended over head.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Scott C Lester, MD — Mayo Clinic, Rochester, MN
- Study coordinator: New Phase Clinical Team
- Email: clinicalstudy@newphase.co.il
- Phone: +972-3-6798687
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.