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

Launched by BEYOND AIR INC. · Apr 25, 2022

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment involving nitric oxide injections for patients with certain types of cancer that cannot be surgically removed. The study aims to assess how safe this treatment is and whether it can help patients with unresectable solid tumors, either primary tumors or those that have spread from other areas. To participate, individuals must be at least 18 years old and have a specific type of tumor that hasn’t responded to standard therapies. Participants should also have a life expectancy of at least three months and meet other health criteria.

During the trial, eligible participants will receive a single treatment session, followed by a monitoring period of about three weeks to evaluate their safety and response to the treatment. The study is currently looking for volunteers, and those who join will be closely watched for any side effects and overall health for up to 12 weeks after the treatment. It's important for potential participants to know that certain health conditions and recent treatments may exclude them from the study, so discussing eligibility with a healthcare provider is essential.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient (male or female) is at least 18 years of age at the time of signature of the informed consent form.
• • Patient has an ECOG Performance Status score of 0-3 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. Up to five target lesions may be identified.
• • 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.
• • Patient have adequate hematologic and organ function.
• • Patient have not had radiotherapy to the targeted lesions within the preceding 12 months.
• • Superficial tumor axis minimum length and depth of 4.5mm. .
• • Patient is not with childbearing potential or agrees to use adequate contraceptive methods
• Exclusion Criteria:
• • The tumor is situated in the lymph node, in thyroid, close to trachea or in facial area or other region which, in the Investigator's opinion, can pose extra risk to the patient.
• • 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, neuropathy and protocol-defined laboratory values.
• • 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 enrolment.
• • Known active infection and uncontrolled intercurrent illness.
• • Receiving drugs that have contraindication with NO.
• • Patient is receiving anticoagulants including low molecular weight heparin.