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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

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

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 9 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 currently in Phase 1 clinical development, and it is being evaluated both alone and in combination with nivolumab in patients with advanced solid tumors.

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 symbol BMY. The company is conducting a Phase 1 clinical trial of this investigational small molecule in advanced solid tumors.

What phase is BMS-986449 in?

BMS-986449 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is active but not recruiting participants, and it is studying the drug with and without nivolumab in advanced solid tumors.

What clinical trials is BMS-986449 in?

BMS-986449 is being studied in one active Phase 1 clinical trial, identified as NCT05888831. This trial is evaluating BMS-986449 with and without nivolumab in participants with advanced solid tumors, with a planned enrollment of 100 participants across the United States, Belgium, France, Italy, Netherlands, and Spain.

How does BMS-986449 work?

The specific molecular target of BMS-986449 has not been disclosed in the available information. It is a small molecule modality, and its mechanism of action is being investigated in the context of advanced solid tumors, both as a monotherapy and in combination with nivolumab.