A Study to Assess the Safety and Efficacy of Nitric Oxide Injection Into Unresectable Solid Primary or Metastatic Tumors
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
Beyond Air Inc.
38 participants
Aug 14, 2022
INTERVENTIONAL
Conditions
Summary
This is a Phase 1, open-label, dose-escalation and dose-expansion study comprised of a screening period, a single treatment session, an evaluation period of 21±3 days, and safety and survival follow-up period of up to 12 weeks post-treatment.
Eligibility
Inclusion Criteria9
- 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 Criteria10
- 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.
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Interventions
Intratumoral injection of 25,000 gNO
Intratumoral injection of 50000 gNO
Intratumoral injection of 100,000 gNO
Intratumoral injection of selected does on gNO
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05351502