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BMS-986449

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jun 11, 2025

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 Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05888831A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 100 — — Jun 6, 2023Sep 30, 2026Jun 11, 202520 United States, Belgium +4
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Study Endpoints
Primary Endpoints
Number of participants with Dose-Limiting Toxicities (DLTs)
Up to approximately 4 years
Number of participants with Adverse Events (AEs)
Up to approximately 4 years
Number of participants with Serious Adverse Events (SAEs)
Up to approximately 4 years
Number of participants with AEs leading to discontinuation
Up to approximately 4 years
Number of deaths
Up to approximately 4 years
Secondary Endpoints
Maximum observed plasma concentration (Cmax)
Up to approximately 4 years
Time of maximum observed concentration within a dosing interval (Tmax)
Up to approximately 4 years
Area under the concentration-time curve within a dosing interval (AUC[TAU])
Up to approximately 4 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose Escalation: BMS-986449 monotherapyEXPERIMENTAL -
Dose Escalation: BMS-986449 + nivolumabEXPERIMENTAL -
Dose Escalation: BMS-986449 monotherapy pharmacodynamic (PD) cohortsEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986449DRUGSpecified dose on specified days
NivolumabDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy (measurable by Response Evaluation Criteria in Solid Tumors \[RECIST\] v1.1), and have received, be refractory to, ineligible for, or intolerant of exist...

Countries:United StatesBelgiumFranceItalyNetherlandsSpain
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05888831primaryCompletionDate: changed
LOWMay 24, 2026NCT05888831studyFirstPostDate: changed