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BMS-986523

Phase 1

Advanced Solid Malignancies | Small molecule | Oncology |Bristol-Myers Squibb Company|Trials Updated: May 28, 2026

BMS-986523 development status

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment252

FDA Designations

No designations recorded

BMS-986523 clinical trials

BMS-986523 · 1 trial · 4 indications

Phase 1 1
NCT07223047A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid MalignanciesAdvanced Solid Malignancies
RECRUITING252 Analytics
PHASE1RECRUITING
A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies
Advanced Solid MalignanciesUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with adverse events (AEs)
Up to 3 years
Number of participants with serious adverse events (SAEs)
Up to 3 years
Number of participants with AEs meeting protocol-defined dose limiting toxicity (DLT) criteria
Up to 3 years
Number of participants with AEs leading to discontinuation
Up to 3 years
Number of deaths
Up to 3 years

Secondary Endpoints

Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator.
Up to 3 years
Duration of response (DOR) per RECIST v1.1 as assessed by the investigator.
Up to 3 years
Maximum observed plasma concentration (Cmax)
Up to 3 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTAL -
Arm BEXPERIMENTAL -
Arm CEXPERIMENTAL -
Arm DEXPERIMENTAL -
Arm EEXPERIMENTAL -
Arm FEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986523DRUGSpecified dose on specified days
GemcitabineDRUGSpecified dose on specified days
Nab-PaclitaxelDRUGSpecified dose on specified days
CetuximabDRUGSpecified dose on specified days
PembrolizumabDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria * Participants must have a histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with a known Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration (mutation or amplification). * Participants must, for Arm D, have a ...

Countries:United StatesCanadaSpain
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Frequently asked questions about BMS-986523

What is BMS-986523 used for?

BMS-986523 is an investigational small molecule being studied in adults with advanced solid malignancies. The Phase 1 trial enrolls patients with non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma. It is not approved for any indication and remains in clinical development.

Who is developing BMS-986523?

BMS-986523 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is the sole sponsor listed for the ongoing Phase 1 study of the compound in advanced solid malignancies.

What phase is BMS-986523 in?

BMS-986523 is in Phase 1 clinical development. One Phase 1 trial is currently recruiting, and no later-stage trials have been completed. The study is designed to evaluate safety, tolerability, and efficacy in participants with advanced solid malignancies.

What clinical trial is BMS-986523 in?

BMS-986523 is being evaluated in the recruiting Phase 1 trial NCT07223047, titled a study of BMS-986523 alone and in combination with anti-cancer agents in participants with advanced solid malignancies. The trial plans to enroll 252 participants across the United States, Canada, and Spain.

Is BMS-986523 biomarker selected?

Yes. The Phase 1 trial NCT07223047 for BMS-986523 is biomarker selected, meaning enrollment is guided by a defined biomarker rather than an unselected patient population. The study enrolls adults 18 years and older of any sex with advanced solid malignancies.

Is BMS-986523 given alone or in combination?

BMS-986523 is being tested both as a single agent and in combination with anti-cancer agents in the Phase 1 trial NCT07223047. The study is controlled but is not randomized and is not double blinded, and it is currently recruiting participants.