NCT04773275

A Clinical Evaluation of the Aliya™ System in Late Stage Cancer

INCITE LS: A Clinical Evaluation of the Aliya™ System in Late Stage Cancer

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Galvanize Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, single-arm, non-randomized, multi-center, open-label study following patients to 1 year. The study is designed to evaluate the safety and clinical utility of Pulsed Electric Field (PEF) treatment of advanced stage or metastatic cancer following progression on immunotherapy.

Detailed description

This study is designed to evaluate the safety and clinical utility of Pulsed Electric Field (PEF) treatment of advanced stage or metastatic cancer following progression on immunotherapy. The study will enroll adult patients with confirmed 8th ed. Stage IV non-small cell lung cancer (NSCLC), Stage IV renal cell carcinoma (RCC), or Stage IV hepatocellular carcinoma (HCC), who have experienced a response to checkpoint inhibitor (CPI) therapy (complete response (CR), partial response (PR), or stable disease (SD) as per RECIST 1.1) for a minimum of 6 months, and have documented radiologic progression (progressive disease (PD) as defined by RECIST 1.1) in up to five sites (non-central nervous system). PEF treatment delivery is to be performed in conjunction with the clinically appropriate approach to collect standard of care biopsy samples to confirm disease progression. The PI has the discretion to approach via endoluminal or percutaneous method if the target(s) is/are amenable. PEF treatment will be delivered to accessible new areas of growth on existing tumors or new tumors. Treatment may be delivered via either an endoluminal (bronchoscopic) or percutaneous approach at the discretion of the clinical investigator utilizing two available device configurations: * Endoluminal: Galvanize Aliya System with compatible commercially available TBNA Needle and RF probe electrode * Percutaneous: Galvanize Aliya System with compatible commercially available RF needle and RF probe electrode The study will enroll and treat up to 30 adult patients at up to 5 clinical sites.

Conditions

• Cancer of Lung, Kidney or Liver

Interventions

Type	Name	Description
DEVICE	Pulsed electric field treatment using the Aliya system	Patients will undergo pulsed electric field (PEF) treatment of up to 5 tumors (new or progressing) measuring ≤ 2cm in longest diameter.

Timeline

• Start date: 2022-05-09
• Primary completion: 2023-02-23
• Completion: 2023-04-21
• First posted: 2021-02-26
• Last updated: 2025-08-01

Locations

3 sites across 3 countries: Hong Kong, Netherlands, Spain

Regulatory

• FDA-regulated device study