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

Sponsor
Beyond Air Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05351502
Collaborator
(none)
38
4
12

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
  • Drug: Nitric Oxide 25,000 ppm
  • Drug: Nitric Oxide 50,000 ppm
  • Drug: Nitric Oxide 100,000 ppm
  • Drug: Nitric Oxide selected dose
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

Study Type:
Interventional
Anticipated Enrollment :
38 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
In Part A, the following gNO doses will be studied to determine MTD: 25,000 ppm, 50,000 ppm and 100,000 ppm. Once the MTD is determined, additional patients will be treated in Part B Dose Expansion to further characterize the safety and biomarkers of gNO and determine RP2D.In Part A, the following gNO doses will be studied to determine MTD: 25,000 ppm, 50,000 ppm and 100,000 ppm. Once the MTD is determined, additional patients will be treated in Part B Dose Expansion to further characterize the safety and biomarkers of gNO and determine RP2D.
Masking:
None (Open Label)
Primary Purpose:
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
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Apr 30, 2023

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:
  • gNO injection
  • 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

    1. 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

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    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.
    Responsible Party:
    Beyond Air Inc.
    ClinicalTrials.gov Identifier:
    NCT05351502
    Other Study ID Numbers:
    • BA-ONC-01
    First Posted:
    Apr 28, 2022
    Last Update Posted:
    Apr 28, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Beyond Air Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 28, 2022