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BMS-986517

Phase 1

Solid Tumours | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Aug 11, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment540

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986517 · 1 trial · 1 indication

Phase 1 1
NCT07160725A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid TumorsSolid Tumours
RECRUITING540 Analytics
PHASE1RECRUITING
A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors
Solid TumoursUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Adverse Events (AE)
Up to approximately 2 years
Number of Participants with Serious Adverse Events (SAE)
Up to approximately 2 years
Number of Participants with AEs meeting protocol-defined Dose-limiting Toxicities (DLTs) criteria
Up to Day 21

For part 1 only

Number of Participants with AEs Leading to Discontinuation
Up to approximately 2 years
Number of Participants with AEs Leading to Deaths
Up to approximately 2 years

Secondary Endpoints

Objective Response Rate (ORR) Assessed by RECIST v1.1 per investigator assessment
Up to approximately 3 years
Duration of Response (DOR) Assessed by RECIST v1.1 per investigator assessment
Up to approximately 3 years
Maximum Plasma Concentration (Cmax)
Up to approximately 2 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1A Monotherapy Dose EscalationEXPERIMENTAL -
Part 1B Combination Dose EscalationEXPERIMENTAL -
Part 1C: Monotherapy PD Sub-studyEXPERIMENTAL -
Part 2A: Monotherapy Dose Expansion Cohort AEXPERIMENTAL -
Part 2A: Monotherapy Dose Expansion Cohort BEXPERIMENTAL -
Part 2A: Monotherapy Dose Expansion Cohort CEXPERIMENTAL -
Part 2B: Combination Dose Expansion Cohort AEXPERIMENTAL -
Part 2B: Combination Dose Expansion Cohort BEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986517DRUGSpecified dose on specified days
PumitamigDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria * Participants must have an ECOG performance status of 0 to 1. * Participants must have measurable disease by RECIST v1.1 (radiologically measured by the Investigator). * Participants must have documented histologically or cytologically confirmed advanced, unresectable/metastatic...

Countries:United StatesChinaDenmarkJapanSpain
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumours")

Recent Changes (Last 90 Days)

LOWAug 11, 2026NCT07160725lastUpdatePostDate: changed
LOWAug 11, 2026NCT07160725lastUpdatePostDate: changed
MEDIUMJul 24, 2026NCT07160725Enrollment: 315 → 540
MEDIUMJul 24, 2026NCT07160725Enrollment: 315 → 540
LOWJun 25, 2026NCT07160725lastUpdatePostDate: changed
LOWJun 25, 2026NCT07160725lastUpdatePostDate: changed
LOWJun 25, 2026NCT07160725lastUpdatePostDate: changed
LOWJun 16, 2026NCT07160725lastUpdatePostDate: changed
LOWJun 16, 2026NCT07160725lastUpdatePostDate: changed
LOWJun 16, 2026NCT07160725lastUpdatePostDate: changed

Frequently asked questions about BMS-986517

What is BMS-986517 used for?

BMS-986517 is an investigational small molecule being developed for the treatment of solid tumors. It is currently in Phase 1 clinical development, with a first-in-human study evaluating its safety and efficacy in participants with advanced solid tumors.

Who makes BMS-986517?

BMS-986517 is being developed by Bristol-Myers Squibb Company (ticker: BMY). The company is conducting a Phase 1/2a first-in-human study of the drug in participants with advanced solid tumors.

What phase is BMS-986517 in?

BMS-986517 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing study is a Phase 1/2a first-in-human trial in participants with advanced solid tumors.

What clinical trials is BMS-986517 in?

BMS-986517 is being studied in a Phase 1/2a first-in-human trial (NCT07160725) in participants with advanced solid tumors. The trial is recruiting and aims to enroll 540 participants across the United States, China, Denmark, Japan, and Spain.

Is BMS-986517 a small molecule?

Yes, BMS-986517 is a small molecule drug. It is being developed as an oral or injectable therapy for solid tumors, though the specific route of administration is not disclosed in the available clinical trial information.