Assessing Nitric Oxide Injection for Unresectable 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
This study is testing if a single injection of nitric oxide can help people with stubborn skin tumors that haven't improved with regular treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beyond Air Inc. Industry-sponsored |
| Locations | 4 sites (Beersheba and 3 other locations) |
| Trial ID | NCT05351502 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial evaluates the safety and efficacy of a single injection of nitric oxide (gNO) into patients with unresectable cutaneous or subcutaneous solid tumors that have not responded to standard treatments. The study consists of a dose-escalation phase to determine the maximum tolerated dose and a potential dose expansion phase. Participants will undergo a screening period followed by treatment and a follow-up evaluation period of up to 12 weeks. The trial aims to provide foundational data for future studies on gNO treatment in cancer patients.
Who should consider this trial
Good fit: Ideal candidates are adults with unresectable solid tumors that have failed standard therapies and have no proven effective treatment options.
Not a fit: Patients with tumors that are amenable to standard therapies or those with a life expectancy of less than three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with difficult-to-treat solid tumors.
How similar studies have performed: While this approach is novel, similar studies exploring nitric oxide in cancer treatment have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beersheba and 3 other locations
- Soroka Medical Center — Beersheba, Israel (Recruiting)
- Hadassah Ein-Karem — Jerusalem, Israel (Recruiting)
- Sheba Medical Center — Ramat Ef‘al, Israel (Recruiting)
- Sourasky Tel Aviv Medical Center — Tel Aviv, Israel (Recruiting)
Study contacts
- Study coordinator: Edith Dekel
- Email: edekel@beyondcancer.com
- Phone: 972-50-8464449
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.