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

• Status: Not yet recruiting
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1, open-label, dose-escalation and dose-expansion study comprised of a screening period, a single treatment session, and follow-up period of up to 60±5 days post-treatment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beyond Air Inc.
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

• Patient has an ECOG Performance Status score of 0-2 and with a life expectancy of ≥3 months

• Patient must have a confirmed diagnosis of at least one unresectable cutaneous or subcutaneous histologically confirmed primary or metastatic solid tumor

• No therapy of proven efficacy exists for the tumor, the tumor is not amenable to standard therapies, the tumor has failed to respond to standard therapy or has progressed despite standard therapy.

• Patient has measurable disease on imaging based on RECIST Version 1.1 or non-measurable disease

Exclusion Criteria:

• The tumor is situated in the lymph node, in thyroid, close to trachea or in facial area

• Has received prior systemic anti-cancer therapy including investigational agents within 14 days of the start of study treatment

• Active central nervous system tumors or metastases.

• Received systemic corticosteroid therapy ≤1 week prior to study treatment or any other form of systemic immunosuppressive medication for medically significant acute or chronic conditions.

• Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and protocol-defined laboratory values (patients with Grade ≥ 2 neuropathy may be included on a case-by-case basis after consultation with the Medical Monitor).

• Active or prior documented autoimmune or inflammatory disorders

• History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of enrollment.