Sarah Nanotechnology System treatment using magnetic hyperthermia for advanced metastatic solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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. 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.
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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SLR-108 PET Imaging for Metastatic Solid Tumors

  A Phase 1 study to see if SLR-108 can be safely used for PET imaging of metastatic solid tumors in adults.

  Recruiting Phase 1 Solve Therapeutics · Newport Beach, California · NCT07728942

• TROP2-targeted CAR-NK cell therapy for advanced solid tumors

  This study tests EB-NK-301, an off-the-shelf CAR-NK cell therapy, in adults with advanced or metastatic TROP2-expressing solid tumors after standard treatments have failed.

  Recruiting Phase 1/2 Beijing Biotech · Shenzhen, Guangdong · NCT07589530

• Combining RAS(ON) inhibitors with ivonescimab for adults with RAS‑mutant advanced solid tumors

  This trial will test whether combining RAS(ON) inhibitors with ivonescimab is safe and can shrink or control tumors in adults with advanced or metastatic solid tumors that have RAS mutations.

  Recruiting at 19 sites Phase 1/2 Revolution Medicines, Inc. · Scottsdale, Arizona and 18 other locations · NCT07397338

• ADCX-020 treatment for advanced or metastatic solid tumors

  This trial will test ADCX-020, an antibody–drug conjugate, in adults with advanced or metastatic solid tumors who have run out of standard treatment options.

  Recruiting at 9 sites Phase 1 Adcytherix SAS · Sydney, New South Wales and 8 other locations · NCT07238075

• CKD-512 alone and with pembrolizumab for advanced or metastatic solid tumors

  This study will try CKD-512 by itself and together with pembrolizumab in people with advanced or metastatic solid tumors who have exhausted standard treatments.

  Recruiting Phase 1 Chong Kun Dang Pharmaceutical · Seoul · NCT07215637

• AVZO-103 alone and with other treatments for advanced urothelial and other solid tumors

  This trial will test intravenous AVZO-103, alone and combined with other cancer drugs, to see if it is safe and helps adults with locally advanced or metastatic urothelial cancer or other solid tumors.

  Recruiting at 15 sites Phase 1/2 Avenzo Therapeutics, Inc. · San Francisco, California and 14 other locations · NCT07193511

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.