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

NCT05351502 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-08-16

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Beyond Air Inc.

    lead INDUSTRY

Principal Investigators

  • David Greenberg, MD · Study Internal Medical Monitor

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-14
Primary Completion
2025-05-30
Completion
2025-06-30

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05351502 on ClinicalTrials.gov