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BMS-986406

Phase 1

Advanced Cancer | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: Sep 26, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment77
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05298592A Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced TumorsPHASE1 COMPLETED 77Mar 31, 2022Aug 16, 2024Sep 26, 202429 United States, Argentina +4
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Study Endpoints
Primary Endpoints
Number of participants with adverse events (AEs)
Up to 100 days
Number of participants with serious adverse events (SAEs)
Up to 100 days
Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Up to 28 days
Number of participants with AEs leading to discontinuation
Up to 100 days
Number of participants with death
Up to 100 days
Secondary Endpoints
Maximum observed plasma concentration (Cmax)
Up to 14 days
Time of maximum observed plasma concentration (Tmax)
Up to 14 days
Trough observed plasma concentration (Ctrough)
Up to 14 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1A: BMS-986406 (Monotherapy Dose Escalation)EXPERIMENTAL -
Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation)EXPERIMENTAL -
Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion)EXPERIMENTAL -
Part 2: BMS-986406 + Nivolumab (Expansion Cohorts)EXPERIMENTAL -
Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or PaclitaxelEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986406BIOLOGICALSpecified dose on specified days
NivolumabBIOLOGICALSpecified dose on specified days
CarboplatinDRUGSpecified dose on specified days
PemetrexedDRUGSpecified dose on specified days
PaclitaxelDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites29

Inclusion Criteria: Parts 1A, 1B, 1C: * Histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent malignant tumor. Eligible tumor types are non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastr...

Countries:United StatesArgentinaBelgiumJapanSouth KoreaSpain
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