Aliya™ Pulsed Electric Fields (PEF) for Advanced Cancer (AFFINITY)

A Clinical Study of Aliya™ Pulsed Electric Fields (PEF) Delivered Prior to Standard of Care Treatment for Advanced Cancer

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.

Study Overview

• Status: Completed
• Conditions: Lung Neoplasm Malignant
• Intervention / Treatment: Device: Aliya Pulsed Electric Fields (PEF)

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine | New York-Presbyterian
  • North Carolina
    • Pinehurst, North Carolina, United States, 28374
      • FirstHealth of the Carolinas, Inc.
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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,

Other protocol defined inclusion/exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aliya PEF; Pulsed electric field treatment using the Aliya System	Device: Aliya Pulsed Electric Fields (PEF); Percutaneous or Endobronchial PEF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	The frequency with which physicians can deliver PEF energy to intended targets	Day of procedure
Anesthesia Type Usage	Anesthesia Type Usage	During PEF procedure
PEF Target Location	Anatomic lung region treated with PEF	During PEF procedure
Initiation of first-line (1L) SOC therapy following PEF treatment	Time to initiate first-line (1L) SOC therapy following PEF treatment	12 months

Collaborators and Investigators

• Sponsor: Galvanize Therapeutics, Inc.
• Investigators: Study Chair: William Krimsky, MD, Chief Medical Officer

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2023
• Primary Completion (Actual): August 13, 2025
• Study Completion (Actual): August 13, 2025

Study Registration Dates

• First Submitted: May 5, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): June 6, 2023

Study Record Updates

• Last Update Posted (Actual): August 20, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Thoracic Neoplasms; Immunologic Factors; Lung Neoplasms
• Additional Relevant MeSH Terms: Neoplasms by Site; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms; Lung Neoplasms
• Other Study ID Numbers: CSP-00018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes