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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

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Trial Profile

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 of Trial: Phase I

Latest Information Update: 23 Jun 2025

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At a glance

  • Drugs Nitric oxide (Primary) ; Antineoplastics
  • Indications Skin cancer; Solid tumours; Triple negative breast cancer
  • Focus Adverse reactions; First in man; Proof of concept
  • Sponsors Beyond Air

Most Recent Events

  • 17 Jun 2025 According to a Beyond Cancer media release, Part A of the trial evaluating ultra-high concentration Nitric Oxide (UNO) therapy in subjects with advanced, relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous solid tumors at a dose of 25,000 ppm has been completed.
  • 10 Feb 2025 According to a Beyond Cancer media release, topline data from the Phase 1b portion of the study are anticipated late in calendar 2025 or early-2026.
  • 03 Dec 2024 According to a Beyond Cancer media release, the company announced that topline data from the Phase 1b portion of the study are anticipated in the second half of 2025.

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