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A Study to Assess the Safety and Efficacy of Nitric Oxide Injection Into Unresectable Solid Primary or Metastatic Tumors
Sponsor: Beyond Air Inc.
Summary
This is a Phase 1, open-label, dose-escalation and dose-expansion study comprised of a screening period, a single treatment session, an evaluation period of 21±3 days, and safety and survival follow-up period of up to 12 weeks post-treatment.
Official title: A Phase 1, Open-Label, Dose Escalation and Dose Expansion Study to Assess the Safety and Efficacy of Nitric Oxide Injection Into Unresectable Solid Cutaneous/Subcutaneous Primary or Metastatic Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
38
Start Date
2022-08-14
Completion Date
2025-06-30
Last Updated
2024-08-16
Healthy Volunteers
No
Conditions
Interventions
Nitric Oxide 25,000 ppm
Intratumoral injection of 25,000 gNO
Nitric Oxide 50,000 ppm
Intratumoral injection of 50000 gNO
Nitric Oxide 100,000 ppm
Intratumoral injection of 100,000 gNO
Nitric Oxide selected dose
Intratumoral injection of selected does on gNO
Locations (4)
Soroka Medical Center
Beersheba, Israel
Hadassah Ein-Karem
Jerusalem, Israel
Sheba Medical Center
Ramat Ef‘al, Israel
Sourasky Tel Aviv Medical Center
Tel Aviv, Israel