A Study to Assess the Safety and Efficacy of Nitric Oxide Injection Into Unresectable Solid Primary or Metastatic Tumors
Trial Parameters
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-up period of up to 12 weeks post-treatment.
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 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 method