NCT05351502

A Study to Assess the Safety and Efficacy of Nitric Oxide Injection Into Unresectable Solid Primary or Metastatic Tumors

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Beyond Air Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this Phase 1 study is to initiate clinical development of gNO in patients with unresectable cutaneous or subcutaneous primary or metastatic solid tumors that are not amenable or have failed standard treatment, for which no therapy of proven efficacy exists, or which has progressed despite standard therapy. This study of gNO treatment will consist of 2 parts: a dose-escalation part to establish a safe and tolerable dose of gNO in patients with primary or metastatic unresectable cutaneous or subcutaneous solid tumors (Part A), and a dose expansion phase (Part B) which may be initiated at the Sponsor's discretion after the maximum tolerated dose (MTD) and/or optimal biological dose (OBD) (or recommended Phase 2 dose \[RP2D\]) has been determined in the dose-escalation phase (Part A). This study will be the basis for future studies.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Nitric Oxide 25,000 ppm	Intratumoral injection of 25,000 gNO
DRUG	Nitric Oxide 50,000 ppm	Intratumoral injection of 50000 gNO
DRUG	Nitric Oxide 100,000 ppm	Intratumoral injection of 100,000 gNO
DRUG	Nitric Oxide selected dose	Intratumoral injection of selected does on gNO

Timeline

• Start date: 2022-08-14
• Primary completion: 2025-05-30
• Completion: 2025-06-30
• First posted: 2022-04-28
• Last updated: 2024-08-16

Locations

4 sites across 1 country: Israel