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BMS-986488

Phase 1

Advanced Malignant Tumors | Small molecule | Oncology |Bristol-Myers Squibb Company|Trials Updated: Jul 29, 2026

BMS-986488 development status

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment437

FDA Designations

No designations recorded

BMS-986488 clinical trials

BMS-986488 · 1 trial · 1 indication

Phase 1 1
NCT06764771A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant TumorsAdvanced Malignant Tumors
RECRUITING437 Analytics
PHASE1RECRUITING
A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
Advanced Malignant TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with Adverse Events (AEs)
Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Number of participants with Serious AEs (SAEs)
Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria
From first dose of study treatment until end of cycle 1 (1 Cycle = 28 Days)
Number of participants with AEs leading to discontinuation
Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Number of deaths
From time of informed consent up to 52 weeks after end of treatment visit

Secondary Endpoints

Maximum observed plasma concentration (Cmax)
Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Time of maximum observed concentration (Tmax)
Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Until Cycle 4, Day 1 (1 Cycle = 28 Days)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1A: BMS-986488 MonotherapyEXPERIMENTAL -
Part 1B: BMS-986488 + AdagrasibEXPERIMENTAL -
Part 1C: BMS-986488 + Adagrasib + CetuximabEXPERIMENTAL -
Part 1D: BMS-986488 + NivolumabEXPERIMENTAL -
Part 2A: BMS-986488 MonotherapyEXPERIMENTAL -
Part 2B: BMS-986488 + AdagrasibEXPERIMENTAL -
Part 2C: BMS-986488 + Adagrasib + CetuximabEXPERIMENTAL -
Part 2D: BMS-986488 + NivolumabEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986488DRUGSpecified dose on specified days
AdagrasibDRUGSpecified dose on specified days
CetuximabDRUGSpecified 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 Sites8

Inclusion Criteria: * Participant must be ≥ 18 years of age. * Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with any of the following tumor types:. * Part 1A: clear-cell renal cell carcinoma (ccRCC), clear-cell ovarian cancer (ccOC),...

Countries:United StatesAustraliaCanada
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Recent Changes (Last 90 Days)

LOWJul 29, 2026NCT06764771lastUpdatePostDate: changed
LOWJul 29, 2026NCT06764771lastUpdatePostDate: changed

Frequently asked questions about BMS-986488

What is BMS-986488?

BMS-986488 is an investigational small molecule being developed by Bristol-Myers Squibb for the treatment of advanced malignant tumors. It is currently in Phase 1 clinical development and is being studied both as a monotherapy and in combination therapy in adult patients with advanced solid tumors.

What is BMS-986488 used for in advanced malignant tumors?

BMS-986488 is being evaluated for the treatment of advanced malignant tumors in adults. It is an investigational therapy in Phase 1 testing and is not yet approved for any indication. The trial enrolls patients with advanced malignant tumors and includes biomarker-selected participants.

Who makes BMS-986488?

BMS-986488 is developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. Bristol-Myers Squibb is the sponsor of the ongoing Phase 1 clinical trial evaluating the compound in patients with advanced malignant tumors.

What phase is BMS-986488 in?

BMS-986488 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA for any indication. The single ongoing Phase 1 trial is currently recruiting participants with advanced malignant tumors.

What clinical trials is BMS-986488 in?

BMS-986488 is being studied in one Phase 1 clinical trial, NCT06764771, titled A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors. The trial is recruiting, has an estimated enrollment of 437 participants, and is conducted in the United States, Australia, and Canada.