A Study to Assess the Safety and Efficacy of Nitric Oxide Injection Into Unresectable Solid Primary or Metastatic Tumors
Recruiting
Phase 1
Interventional Study
Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 38 (estimated)
- Sponsor
- Beyond Air Inc. · Industry
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About This Trial
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.
Trial Locations
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Eligibility 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 cut…
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