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BMS-986523

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment252

FDA Designations

No designations recorded

Clinical trial landscape

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 Malignancies
NCT07223047252
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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 developed for the treatment of advanced solid malignancies, including non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes BMS-986523?

BMS-986523 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting a Phase 1 clinical trial to evaluate the drug's safety, tolerability, and efficacy in participants with advanced solid tumors.

What phase is BMS-986523 in?

BMS-986523 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is currently recruiting participants to evaluate the drug's safety, tolerability, and efficacy in advanced solid malignancies.

What clinical trials is BMS-986523 in?

BMS-986523 is being studied in a single Phase 1 clinical trial registered as NCT07223047. This trial evaluates the drug alone and in combination with anti-cancer agents in participants with advanced solid malignancies, including non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma. The trial is currently recruiting and aims to enroll 252 participants.

Is BMS-986523 being studied in combination with other drugs?

Yes, the Phase 1 clinical trial NCT07223047 is evaluating BMS-986523 both alone and in combination with anti-cancer agents. The study is designed to assess the safety, tolerability, and efficacy of these treatment regimens in participants with advanced solid malignancies, including non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma.