Actively Recruiting
A Study to Assess the Safety and Efficacy of Nitric Oxide Injection Into Unresectable Solid Primary or Metastatic Tumors
Led by Beyond Air Inc. · Updated on 2024-08-16
38
Participants Needed
4
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Assess the Safety and Efficacy of Nitric Oxide Injection Into Unresectable Solid Primary or Metastatic Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 6 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
You will not qualify if you...
- 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 41 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Soroka Medical Center
Beersheba, Israel
Actively Recruiting
2
Hadassah Ein-Karem
Jerusalem, Israel
Actively Recruiting
3
Sheba Medical Center
Ramat Ef‘al, Israel
Actively Recruiting
4
Sourasky Tel Aviv Medical Center
Tel Aviv, Israel
Actively Recruiting
Research Team
E
Edith Dekel
CONTACT
Y
Yaara Ber, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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