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BMS-986517

Phase 1

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

BMS-986517 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment540

FDA Designations

No designations recorded

BMS-986517 clinical trials

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 10 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

Frequently asked questions about BMS-986517

What is BMS-986517?

BMS-986517 is an investigational small molecule being developed by Bristol-Myers Squibb for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and has not been approved for any indication. The compound is being evaluated as a first-in-human therapy in a biomarker-selected patient population.

What is BMS-986517 used for in solid tumors?

BMS-986517 is being studied for use in patients with advanced solid tumors. It is an investigational agent in Phase 1 development and is not approved for any cancer treatment. The ongoing trial enrolls adults with advanced solid tumors across multiple countries, including the United States, China, Denmark, Japan, and Spain.

Who makes BMS-986517?

BMS-986517 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker symbol BMY. The company is the sponsor of the ongoing Phase 1/2a clinical trial evaluating the compound in advanced solid tumors.

What phase is BMS-986517 in?

BMS-986517 is in Phase 1 clinical development. A Phase 1/2a first-in-human study is currently recruiting participants with advanced solid tumors. The drug is investigational and has not received FDA approval or any regulatory approval for commercial use.

What clinical trials is BMS-986517 in?

BMS-986517 is being evaluated in one active clinical trial, NCT07160725, titled A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors. The trial is currently recruiting, with an estimated enrollment of 540 participants across the United States, China, Denmark, Japan, and Spain.