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Tests treatment safety and results for Cancer
Official title A Study to Assess the Safety and Efficacy of Nitric Oxide Injection Into Unresectable Solid Primary or Metastatic Tumors
ClinicalTrials.gov ID: NCT05351502
What this study is testing
What is Nitric Oxide 25,000 ppm?
Nitric Oxide 25,000 ppm is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for cancer.
Also referred to as gNO injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- No therapy of proven how well it works exists for the tumor, the tumor is not amenable to standard therapies, the tumor has failed to respond to...
- Patient has measurable disease on imaging based on RECIST Version 1.1.
You likely can't join if
- 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...
- 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...
- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, neuropathy and protocol-defined...
- Active or prior documented autoimmune or inflammatory disorders.
See the full eligibility 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 how well it works 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beersheba, Israel
- Jerusalem, Israel
- Ramat Ef‘al, Israel
- Tel Aviv, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beersheba, Israel; Jerusalem, Israel; Ramat Ef‘al, Israel; Tel Aviv, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.