Aliya™ Pulsed Electric Fields (PEF) for Advanced Cancer

NCT ID: NCT05890872

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-06
• Study Completion Date: 2025-08-13

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.

Detailed Description

The Aliya Treatment System is designed to deliver therapeutic PEF energy to target tissues, via either a percutaneous or bronchoscopic approach. In order to evaluate the therapeutic potential of PEF delivered via the Aliya Treatment System as an interventional treatment, this clinical trial will evaluate the safety of delivering Aliya PEF in non-surgical advanced stage disease treatment-naïve patients indicated for diagnostic biopsy and first line (1L) standard of care (SOC) therapy. Additionally, this study will examine the safety of adding PEF treatment to the care pathway for patients with metastatic cancer to the lung or stage IV NSCLC and further assess the potential immune modulation and treatment effect of PEF for providing benefit to oncological patients, as outlined below.

Conditions

Lung Neoplasm Malignant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aliya PEF

Pulsed electric field treatment using the Aliya System

Group Type: EXPERIMENTAL

Aliya Pulsed Electric Fields (PEF)

Intervention Type: DEVICE

Percutaneous or Endobronchial PEF

Interventions

Aliya Pulsed Electric Fields (PEF)

Percutaneous or Endobronchial PEF

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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,

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Galvanize Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Krimsky, MD

Role: STUDY_CHAIR

Chief Medical Officer

Locations

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

Countries

United States

Other Identifiers

CSP-00018

Identifier Type: -

Identifier Source: org_study_id