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BMS-986506

Phase 1

Renal Cell Carcinoma | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: May 5, 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
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment125
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07195682A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)PHASE1 RECRUITING 125 — — Jan 15, 2026Apr 3, 2031May 5, 20269 United States, Canada +2
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Study Endpoints
Primary Endpoints
Number of Participants With Adverse Events (AEs)
Up to approximately 2 years from first dose of BMS-986506
Number of Participants With Serious Adverse Events (SAEs)
Up to approximately 2 years from first dose of BMS-986506
Number of Participants With AEs Meeting Protocol Defined Dose-limiting Toxicity (DLT) Criteria
Up to approximately Day 28
Number of Participants With AEs Leading to Discontinuation
Up to approximately 2 years from first dose of BMS-986506
Number of Participants With AEs Leading to Deaths as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 5.0
Up to approximately 2 years from first dose of BMS-986506
Secondary Endpoints
Maximum Observed Plasma Concentration (Cmax) of BMS-986506
Up to approximately Day 85
Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986506
Up to approximately Day 112
Area Under the Concentration-time Curve Within a Dosing Interval (AUC-TAU) of BMS-986506
Up to approximately Day 112
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BMS-986506: Part 1AEXPERIMENTAL -
BMS-986506: Part 2AEXPERIMENTAL -
BMS-986506: Part 2BEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986506DRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Participants must have histologically confirmed diagnosis of locally advanced or metastatic ccRCC. * For part 1: Participants must have already had at least two different treatment plans in the past, including immunotherapy and a targeted therapy. * For part 2: Participants mu...

Countries:United StatesCanadaFranceSpain
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07195682primaryCompletionDate: changed
LOWMay 24, 2026NCT07195682studyFirstPostDate: changed