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BMS-986449

Phase 1

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

BMS-986449 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2023

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

BMS-986449 clinical trials

BMS-986449 · 1 trial · 1 indication

Phase 1 1
NCT05888831A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid TumorsAdvanced Solid Tumors
ACTIVE NOT_RECRUITING100 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors
Advanced Solid TumorsUnlock trial analytics

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 to 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 10 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about BMS-986449

What is BMS-986449 used for?

BMS-986449 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is in Phase 1 clinical development and is not approved for any indication. The trial enrolls adults with advanced solid tumors and includes a biomarker-selected patient population.

Who makes BMS-986449?

BMS-986449 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is the sponsor of the Phase 1 study evaluating the compound in advanced solid tumors.

What phase is BMS-986449 in?

BMS-986449 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. One Phase 1 trial is currently active, with no completed trials reported to date.

What clinical trials is BMS-986449 in?

BMS-986449 is being evaluated in a single Phase 1 trial, NCT05888831, titled A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors. The study is active but not recruiting, plans to enroll 100 participants, and is running in the United States, Belgium, France, Italy, the Netherlands, and Spain.

How is the BMS-986449 trial designed?

The Phase 1 study NCT05888831 is a controlled trial evaluating BMS-986449 both with and without nivolumab in adults with advanced solid tumors. It is not randomized and not double blinded, enrolls participants aged 18 years and older regardless of sex, and does not include healthy volunteers.