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RECRUITING
NCT05351502
PHASE1

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

Sponsor: Beyond Air Inc.

View on ClinicalTrials.gov

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

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

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