Aliya™ Pulsed Electric Fields (PEF) for Advanced Cancer

Completed · Not applicable

Conditions studied: Lung Neoplasm Malignant

In brief

The goal of this clinical trial is to evaluate safety of delivering Aliya PEF in patients with metastatic cancer within the lungs or stage IV non-small cell lung cancer (NSCLC) who are treatment-naïve and indicated for first-line standard of care (SOC) cancer therapy.

Key facts

Study ID

NCT05890872

Run by

Galvanize Therapeutics, Inc.

People needed

30

Starts

2023-09-06

Expected to finish

2025-08-13

Last updated by the study team

2025-08-20

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patient has suspected or confirmed metastatic cancer within the lungs, or stage IV non-small cell lung cancer (NSCLC) requiring biopsy.
• Patient has radiologically documented suspected, or confirmed tumor(s) that are ≤ 5 cm in longest diameter and deemed by the investigator to be suitable per study procedural guidelines for treatment with PEF.
• Patient is deemed eligible to receive 1L SOC therapy for their malignancy.
• In the opinion of the investigator, the patient is not a surgical candidate for curative intent, or the patient has refused surgery.
• Life expectancy ≥ 6 months.

You may not qualify if…

• Patient has received any prior cancer therapy for current tumor(s) to be treated with PEF.
• Patient is scheduled to receive investigational therapies (including device-based therapy) that may interfere with the study endpoints while on this study.
• Patient has clinical evidence of leptomeningeal disease or brain metastases that require SOC treatment within 4 weeks post-PEF treatment.
• Patient with active, known, or suspected autoimmune disease.
• Patient with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
• Patient has received systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 30 days prior to study enrollment. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease.
• Patient has any history of primary immunodeficiency.
• Patient has clinical signs or symptoms of active tuberculosis infection.
• Patient has documented evidence of acute hepatitis or has an active or uncontrolled infection.
• Patient has undergone major surgery (excluding placement of vascular access) within 28 days prior to study enrollment or has planned major surgeries while enrolled in the study,
• Other protocol defined inclusion/exclusion criteria apply

Where it is running

• Mayo Clinic — Jacksonville, Florida, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Weill Cornell Medicine | New York-Presbyterian — New York, New York, United States
• FirstHealth of the Carolinas, Inc. — Pinehurst, North Carolina, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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