NCT05890872

Aliya™ Pulsed Electric Fields (PEF) for Advanced Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Galvanize Therapeutics, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	Aliya Pulsed Electric Fields (PEF)	Percutaneous or Endobronchial PEF

Timeline

• Start date: 2023-09-06
• Primary completion: 2025-08-13
• Completion: 2025-08-13
• First posted: 2023-06-06
• Last updated: 2025-08-20

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study