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BMS-986463

Phase 1

High-grade Serous Ovarian Carcinoma (HGSOC) | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Apr 15, 2026

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
Premium
Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment240
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06476808A Study to Evaluate the Safety, Tolerability, and Efficacy of Escalating Doses of BMS-986463 in Participants With Select Advanced Malignant Tumors.PHASE1 RECRUITING 240 — — Sep 6, 2024Dec 19, 2028Apr 15, 202617 United States, Canada +3
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Study Endpoints
Primary Endpoints
Number of participants with adverse events (AEs)
Up to 108 weeks
Number of participants with serious adverse events (SAEs)
Up to 108 weeks
Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Up to 108 weeks
Number of participants with AEs leading to discontinuation
Up to 108 weeks
Number of participants with AEs leading to death
Up to 108 weeks
Secondary Endpoints
Maximum observed concentration (Cmax)
Up to 104 weeks
Area under the concentration-time curve (AUC)
Up to 104 weeks
Time of maximum observed concentration (Tmax)
Up to 104 weeks
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1: Dose EscalationEXPERIMENTAL -
Arm 2: Dose ExpansionEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986463DRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria * Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1. * Participants must have at least 1 lesion accessible for biopsy in addition to the target lesion, from which a fresh pre treatment biopsy must be obtained. * Participants must have an un...

Countries:United StatesCanadaFranceItalySpain
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06476808primaryCompletionDate: changed
LOWMay 24, 2026NCT06476808studyFirstPostDate: changed