Status:
RECRUITING
A Study to Assess the Safety and Efficacy of Nitric Oxide Injection Into Unresectable Solid Primary or Metastatic Tumors
Lead Sponsor:
Beyond Air Inc.
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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-u...
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 fa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT05351502
Start Date
August 14 2022
End Date
June 30 2025
Last Update
August 16 2024
Active Locations (4)
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1
Soroka Medical Center
Beersheba, Israel
2
Hadassah Ein-Karem
Jerusalem, Israel
3
Sheba Medical Center
Ramat Ef‘al, Israel
4
Sourasky Tel Aviv Medical Center
Tel Aviv, Israel