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BMS-986148

Phase 1

Advanced Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Mar 19, 2020

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02884726Phase 1 Study of Mesothelin-ADCPHASE1 COMPLETED 8Oct 14, 2016Sep 6, 2017Mar 19, 20201 Japan
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Study Endpoints
Primary Endpoints
Incidence of AEs (Adverse Events)
Day 1 to 30 days after the last dose of BMS-986148

AEs leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline

Incidence of SAEs (Serious Adverse Events)
Day 1 to 30 days after the last dose of BMS-986148

SAEs leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline

Grade of AEs
Day 1 to 30 days after the last dose of BMS-986148

AE leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline

Grade of SAEs
Day 1 to 30 days after the last dose of BMS-986148

SAEs leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline

Secondary Endpoints
Maximum observed concentration (Cmax)
Day 1 to day 84
Time of maximum observed concentration (Tmax)
Day 1 to day 84
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
Day 1 to day 84
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BMS-986148 intravenous infusionEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986148DRUGSpecified dose on specified days
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Must have histological confirmation of advanced and/or metastatic solid tumors which are expected to express mesothelin * Must have received and either pro...

Countries:Japan
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