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BMS-986525

Phase 1

Relapsed/Refractory Small Cell Lung Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Aug 18, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment240

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986525 · 1 trial · 1 indication

Phase 1 1
NCT07325136A Study to Assess the Safety and Tolerability of BMS-986525 Alone and in Combination Therapy in Participants With Relapsed/Refractory Small Cell Lung CancerRelapsed/Refractory Small Cell Lung Cancer
RECRUITING240 Analytics
PHASE1RECRUITING
A Study to Assess the Safety and Tolerability of BMS-986525 Alone and in Combination Therapy in Participants With Relapsed/Refractory Small Cell Lung Cancer
Relapsed/Refractory Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with adverse events (AEs)
Up to approximately 2 years
Number of participants with serious adverse events (SAEs)
Up to approximately 2 years
Number of participants with AEs meeting dose-limiting toxicity (DLT) criteria
Up to 21 days
Number of participants with AEs leading to discontinuation
Up to approximately 2 years
Number of participants with AEs leading to death
Up to approximately 2 years

Secondary Endpoints

Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumor Version 1.1 (RECIST v1.1) by investigator assessment
Up to approximately 3 years
Maximum observed concentration within a dosing interval (Cmax)
Up to approximately 2 years
Time of maximum observed plasma concentration within a dosing interval (Tmax)
Up to approximately 2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1A: BMS-986525 Monotherapy Dose EscalationEXPERIMENTAL -
Part 2A: BMS-986525 Monotherapy Dose ExpansionEXPERIMENTAL -
Part 1B: BMS-986525 Combination with Pumitamig Dose EscalationEXPERIMENTAL -
Part 2B: BMS-986525 Combination with Pumitamig Dose ExpansionEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986525DRUGSpecified 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 Sites13

Inclusion Criteria * Participants must have histologically or cytologically documented relapsed/refractory small cell lung cancer (R/R-SCLC). * Participants must have received at least 1 platinum-based chemotherapy regimen as per locally approved drug labels and institutional guidelines. * In count...

Countries:United StatesChinaItalyJapanRomaniaSpain
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials (matched to "Relapsed/Refractory Small Cell Lung Cancer")

Recent Changes (Last 90 Days)

LOWAug 19, 2026NCT07325136lastUpdatePostDate: changed
LOWAug 19, 2026NCT07325136lastUpdatePostDate: changed
LOWAug 19, 2026NCT07325136lastUpdatePostDate: changed
MEDIUMJul 17, 2026NCT07325136lastUpdatePostDate: changed
MEDIUMJul 17, 2026NCT07325136lastUpdatePostDate: changed

Frequently asked questions about BMS-986525

What is BMS-986525 used for?

BMS-986525 is an investigational small molecule being developed for the treatment of relapsed/refractory small cell lung cancer. It is currently in Phase 1 clinical development, meaning it has not been approved by regulatory authorities and is still being studied for safety and tolerability.

Who makes BMS-986525?

BMS-986525 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and tolerability in patients with relapsed/refractory small cell lung cancer.

What phase is BMS-986525 in?

BMS-986525 is in Phase 1 clinical development. It is an investigational drug, not yet approved by the FDA or other regulatory bodies. The ongoing Phase 1 trial is recruiting participants to assess the safety and tolerability of the drug, both alone and in combination therapy.

What clinical trials is BMS-986525 in?

BMS-986525 is being studied in a Phase 1 clinical trial with the identifier NCT07325136. This trial is currently recruiting and aims to enroll 240 participants with relapsed/refractory small cell lung cancer. The study is being conducted in the United States, China, Italy, Japan, Romania, and Spain.

Is BMS-986525 the same as any other drug?

No alternative names for BMS-986525 have been reported. The drug is identified solely by its development code BMS-986525 and is being studied under the clinical trial NCT07325136 for relapsed/refractory small cell lung cancer.