Aliya™ Pulsed Electric Fields (PEF) for Advanced Cancer

NCT05890872 | Completed FDA Device

• 1 other identifier: CSP-00018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Lung Neoplasm Malignant

Keywords

Lung Neoplasms; Thoracic Neoplasms; Immunologic Factors

Outcome Measures

Primary Outcomes (2)

• Device and Procedure related serious adverse events

  The rate of study device-related and/or PEF procedure-related serious adverse events (SAEs)

  30 days post PEF

• Percentage of subjects whose SOC cancer treatment was not cancelled or postponed

  The percentage of subjects whose SOC cancer treatment was not cancelled or postponed due to a PEF device- or procedure-related AE

  1 year Post PEF

Secondary Outcomes (4)

• Procedural success

  Day of procedure

• Anesthesia Type Usage

  During PEF procedure

• PEF Target Location

  During PEF procedure

• Initiation of first-line (1L) SOC therapy following PEF treatment

  12 months

Study Arms (1)

Aliya PEF

EXPERIMENTAL

Pulsed electric field treatment using the Aliya System

Device: Aliya Pulsed Electric Fields (PEF)

Interventions

Aliya Pulsed Electric Fields (PEF) DEVICE

Percutaneous or Endobronchial PEF

Aliya PEF

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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,

Sponsors & Collaborators

• Galvanize Therapeutics, Inc.: lead

Study Sites (5)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Weill Cornell Medicine | New York-Presbyterian

New York, New York, 10065, United States

Location

FirstHealth of the Carolinas, Inc.

Pinehurst, North Carolina, 28374, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Thoracic Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• William Krimsky, MD

  Chief Medical Officer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: June 6, 2023
• Study Start: September 6, 2023
• Primary Completion: August 13, 2025
• Study Completion: August 13, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)