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Nitric Oxide 25,000 ppm

Phase 1

Cancer | Small molecule | Oncology |Beyond Air, Inc.|Last Updated: Aug 16, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05351502A Study to Assess the Safety and Efficacy of Nitric Oxide Injection Into Unresectable Solid Primary or Metastatic TumorsPHASE1 RECRUITING 38Aug 14, 2022Jun 30, 2025Aug 16, 20244 Israel
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Study Endpoints
Primary Endpoints
Incidence of AEs, SAEs and DLTs (safety) parameters.
up to12 weeks from injection

The incidence and characteristics of adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs) and changes in assessed safety parameters. Toxicity will be graded according to NCI CTCAE version 5.0

Secondary Endpoints
Anti-tumor activity of a single intratumoral gNO injection at all administered doses
up to Day 21 from injection
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALSubjects will receive 25,000 ppm NO
Cohort 2EXPERIMENTALSubjects will receive 50,000 ppm NO
Cohort 3EXPERIMENTALSubjects will receive 100,000 ppm NO
RP2D ExpansionEXPERIMENTALSubjects will receive the RP2D dose of NO
Interventions
NameTypeDescription
Nitric Oxide 25,000 ppmDRUGIntratumoral injection of 25,000 gNO
Nitric Oxide 50,000 ppmDRUGIntratumoral injection of 50000 gNO
Nitric Oxide 100,000 ppmDRUGIntratumoral injection of 100,000 gNO
Nitric Oxide selected doseDRUGIntratumoral injection of selected does on gNO
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

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...

Countries:Israel
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05351502primaryCompletionDate: changed
LOWMay 24, 2026NCT05351502studyFirstPostDate: changed