A Study to Assess the Safety and Efficacy of Nitric Oxide Injection Into Unresectable Solid Primary or Metastatic Tumors
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
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) (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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cohort 1 Subjects will receive 25,000 ppm NO |
Drug: Nitric Oxide 25,000 ppm
Intratumoral injection of 25,000 gNO
Other Names:
|
Experimental: Cohort 2 Subjects will receive 50,000 ppm NO |
Drug: Nitric Oxide 50,000 ppm
Intratumoral injection of 50000 gNO
|
Experimental: Cohort 3 Subjects will receive 100,000 ppm NO |
Drug: Nitric Oxide 100,000 ppm
Intratumoral injection of 100,000 gNO
|
Experimental: expansion Subjects will receive the selected dose of NO |
Drug: Nitric Oxide selected dose
Intratumoral injection of selected does on gNO
|
Outcome Measures
Primary Outcome Measures
- Incidence of AEs, SAEs and DLTs (safety) parameters. [up to 60 days from injection]
The incidence and characteristics of adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs) and changes in assessed safety parameters. Toxicity will be graded according to NCI CTCAE version 5.0
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient has an ECOG Performance Status score of 0-2 and with a life expectancy of ≥3 months
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Patient must have a confirmed diagnosis of at least one unresectable cutaneous or subcutaneous histologically confirmed primary or metastatic solid tumor
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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.
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Patient has measurable disease on imaging based on RECIST Version 1.1 or non-measurable disease
Exclusion Criteria:
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The tumor is situated in the lymph node, in thyroid, close to trachea or in facial area
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Has received prior systemic anti-cancer therapy including investigational agents within 14 days of the start of study treatment
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Active central nervous system tumors or metastases.
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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.
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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).
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Active or prior documented autoimmune or inflammatory disorders
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History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of enrollment.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Beyond Air Inc.
Investigators
- Study Director: David Greenberg, MD, CMO- Israel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BA-ONC-01