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BMS-986158

Phase 1

Advanced Tumors | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: May 8, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment83

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986158 · 2 trials · 2 indications

Phase 1 2
NCT04817007A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis)Myelofibrosis
ACTIVE NOT_RECRUITING216 Analytics
NCT02419417Study of BMS-986158 in Subjects With Select Advanced CancersAdvanced Tumors
COMPLETED83 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis)
MyelofibrosisUnlock trial analytics
PHASE1COMPLETED
Study of BMS-986158 in Subjects With Select Advanced Cancers
Advanced TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events (AEs)
Up to 52 months
Incidence of serious adverse events (SAEs)
Up to 52 months
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Up to 26 months
Incidence of AEs leading to discontinuation
Up to 52 months
Incidence of death
Up to 52 months
Number of Participants Experiencing Adverse Events
From first dose to 30 days following last dose (up to approximately 29 months)

Number of participants experiencing different types of events, including Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation and deaths. Events are classified based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Number of Participants With Abnormal Hepatic Test Values
From first dose to 30 days following last dose (up to approximately 29 months)

Number of participants experiencing abnormal hepatic function, as measured by different parameters. ALT = Alanine aminotransferase AST = Aspartate aminotransferase ULN = Upper Limit of Normal

Secondary Endpoints

Response rate defined as proportion of participants with SVR ≥ 35% by MRI (preferred) or CT (if MRI is contraindicated and if CT is allowed by local guidelines) assessed by BICR
Up to 175 days
Response rate defined as proportion of participants with SVR ≥ 25% by MRI (preferred) or CT (if MRI is contraindicated and if CT is allowed by local guidelines) assessed by BICR
Up to 175 days
Symptom response rate (SRR) based on total symptom score (TSS) measured by Myelofibrosis Symptom Assessment Form (MFSAF)
Up to 175 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1A: BMS-986158 + RuxolitinibEXPERIMENTAL -
Part 1B: BMS-986158 + FedratinibEXPERIMENTAL -
Part 2A1: BMS-986158 + RuxolitinibEXPERIMENTAL -
Part 2B1: BMS-986158 + FedratinibEXPERIMENTAL -
Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicableEXPERIMENTAL -
Part 2A2 Add-On: BMS-986158 + RuxolitinibEXPERIMENTAL -
Part 2A3: BMS-986158 + RuxolitinibEXPERIMENTAL -
Monotherapy TreatmentEXPERIMENTALPatients treated at various doses and schedules
Combination TherapyEXPERIMENTALPatients treated at selected doses and schdules

Interventions

NameTypeDescription
BMS-986158DRUGSpecified dose on specified days
RuxolitinibDRUGSpecified dose on specified days
FedratinibDRUGSpecified dose on specified days
NivolumabBIOLOGICALSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites49

Inclusion Criteria: * Diagnosis of primary myelofibrosis (PMF), post-essential thrombocythemia (ET) or post-polycythemia vera (PV) myelofibrosis * Treatment-related toxicities from prior therapy resolved to Grade 1 or pre-treatment baseline or determined to be irreversible prior to study treatment ...

Countries:United StatesAustraliaFranceGermanyGreeceIsraelItalyPolandRomaniaSouth KoreaSpainCanada
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Frequently asked questions about BMS-986158

What is BMS-986158 used for?

BMS-986158 is an investigational small molecule being studied for the treatment of myelofibrosis and advanced tumors. It is in Phase 1 clinical development by Bristol-Myers Squibb Company (BMY). The drug is not approved and remains under investigation in clinical trials.

What does BMS-986158 target?

BMS-986158 is a small molecule being developed by Bristol-Myers Squibb. Its specific molecular target has not been disclosed in available information. The drug is being studied in Phase 1 trials for myelofibrosis and advanced tumors.

Who makes BMS-986158?

BMS-986158 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with myelofibrosis and advanced tumors.

What phase is BMS-986158 in?

BMS-986158 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. Bristol-Myers Squibb is studying it in patients with myelofibrosis and advanced tumors to assess safety, tolerability, and preliminary efficacy.

What clinical trials is BMS-986158 in?

BMS-986158 is being studied in two Phase 1 trials. NCT02419417, completed, enrolled 83 participants with advanced tumors. NCT04817007, active but not recruiting, is assessing the drug alone and with ruxolitinib or fedratinib in 216 participants with myelofibrosis.

Is BMS-986158 the same as any other drug?

BMS-986158 is the primary name for this investigational compound. No alternative names have been identified in available information. It is a small molecule being developed by Bristol-Myers Squibb for oncology indications.