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ONO-4538

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: May 3, 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
CONTROLLED
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02261298ONO-4538 Phase I Study in Patients With Solid TumorPHASE1 COMPLETED 18Oct 1, 2014Apr 1, 2020May 3, 20245 South Korea
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Study Endpoints
Primary Endpoints
Safety outcome: The number of subjects with overall adverse events
Approximately 6 months
Safety outcome: The number of deaths
Approximately 6 months
PK outcome: Cmax of ONO-4538
Approximately 10 months
Efficacy outcome: Response rate
Approximately 6 months
Efficacy outcome: Progression free survival
Approximately 6 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ONO-4538 1mg/kgEXPERIMENTALONO-4538 water-soluble injection, 100 mg/vial, 1mg/kg, 3 times once every 2 weeks in each 6-week cycle
ONO-4538 3mg/kgEXPERIMENTALONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, 3 times once every 2 weeks in each 6-week cycle
ONO-4538 10mg/kgEXPERIMENTALONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, 3 times once every 2 weeks in each 6-week cycle
Interventions
NameTypeDescription
ONO-4538DRUG -
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * The treatment phase has been completed in the ONO-4538-13 study Exclusion Criteria: * The development of PD is identified by the principal or sub investigator according to the RECIST guideline (version 1.1) only in case in which the unplanned tumor assessment with diagnostic...

Countries:South Korea
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