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BMS-986369

Phase 1

Healthy Participants | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: May 1, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986369 · 4 trials · 5 indications

Phase 1 4
NCT06535399Study to Assess Drug Levels and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Different Degrees of Hepatic ImpairmentHepatic Impairment
COMPLETED29 Analytics
NCT06035497A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)Relapsed or Refractory T-cell Lymphomas
ACTIVE NOT_RECRUITING85 Analytics
NCT05567510A Study to Evaluate the Metabolism and Excretion of BMS-986369 in Healthy Male ParticipantsHealthy Participants
COMPLETED8 Analytics
NCT05350800A Study to Evaluate the Drug Exposure of Single Ascending Doses of BMS-986369 and the Effect of Food on the BMS-986369 in Healthy ParticipantsHealthy Volunteer
COMPLETED68 Analytics
PHASE1COMPLETED
Study to Assess Drug Levels and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Different Degrees of Hepatic Impairment
Hepatic Impairment
NCT0653539929
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PHASE1ACTIVE NOT_RECRUITING
A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)
Relapsed or Refractory T-cell Lymphomas
NCT0603549785
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PHASE1COMPLETED
A Study to Evaluate the Metabolism and Excretion of BMS-986369 in Healthy Male Participants
Healthy Participants
NCT055675108
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PHASE1COMPLETED
A Study to Evaluate the Drug Exposure of Single Ascending Doses of BMS-986369 and the Effect of Food on the BMS-986369 in Healthy Participants
Healthy Volunteer
NCT0535080068
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Study Endpoints

Primary Endpoints

Maximum observed plasma concentration (Cmax)
Up to approximately 44 days
Time of maximum observed plasma concentration (Tmax)
Up to approximately 44 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Up to approximately 44 days
Number of participants with Adverse Events (AEs)
Up to 5 weeks after last dose of treatment

Phase 1 participants

Number of participants with treatment-emergent adverse events (TEAEs)
Up to 5 weeks after last dose of treatment

Phase 1 participants

Number of participants with Dose-Limiting Toxicity (DLT)
Up to 28 days after first dose

Phase 1 participants

Number of participants with laboratory abnormalities
Up to 5 weeks after last dose of treatment

Phase 1 participants

Number of participants with vital sign abnormalities
Up to 5 weeks after last dose of treatment

Phase 1 participants

Number of participants with Electrocardiogram (ECG) abnormalities
Up to 5 weeks after last dose of treatment

Phase 1 participants

Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Up to 5 weeks after last dose of treatment

Phase 1 participants

Number of participants with Left Ventricular Ejection Fraction (LVEF) assessment abnormalities
Up to 5 weeks after last dose of treatment

Phase 1 participants

Number of participants with Physical Examination (PE) abnormalities
Up to 5 weeks after last dose of treatment

Phase 1 participants

Number of participants who achieve Objective Response (OR) as assessed by central review per international consensus response criteria for ATL
Up to 2 years after last does of treatment

Phase 2: Adult T-cell Leukemia-Lymphoma (ATL) cohort OR is defined as the achievement of Partial Response (PR), complete response unconfirmed (CRu), or Complete Response (CR)

Number of participants who achieve OR as assessed by central review per protocol-defined response criteria according to Lugano classification (Computed Tomography(CT)-based)
Up to 2 years after last dose of treatment

Phase 2: Peripheral T-cell Lymphoma (PTCL) cohort OR is defined as the achievement of PR or CR

Total radioactivity recovered in whole blood
Up to 22 days
Total radioactivity recovered in plasma
Up to 22 days
Total radioactivity recovered in urine
Up to 22 days
Total radioactivity recovered in feces
Up to 22 days
Total radioactivity recovered in vomit
Up to 22 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
Up to 22 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Up to 22 days
Total radioactivity recovered in whole blood to plasma ratio
Up to 22 days
Area under the plasma concentration-time curve, from time zero extrapolated to infinite time (AUC(INF))
Up to 336 hours after dose administration

Secondary Endpoints

Incidence of adverse events (AEs)
Up to approximately 44 days
Incidence of serious adverse events (SAEs)
Up to approximately 44 days
Number of participants with physical examination abnormalities
Up to approximately 44 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group A: BMS-986369 Moderate Hepatic ImpairmentEXPERIMENTAL -
Group B: BMS-986369 Severe Hepatic ImpairmentEXPERIMENTAL -
Group C: BMS-986369 Normal Hepatic FunctionEXPERIMENTAL -
Administration of BMS-986369EXPERIMENTAL -
BMS-986369EXPERIMENTAL -
BMS-986369, Part 1 dose escalationEXPERIMENTAL -
BMS-986369 under fasted conditions, Part 2 Food effectEXPERIMENTAL -
BMS-986369 under fed conditions, Part 2 Food effectEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986369DRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria for all Participants (Group A, Group B, Group C): * Body mass index (BMI) between 18 and 40 kg/m\^2 (inclusive), and body weight ≥ 50 kg. Inclusion Criteria for Participants with Moderate or Severe Hepatic Impairment (Group A and Group B): * Participants have moderate HI (Group...

Countries:United StatesJapan
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Frequently asked questions about BMS-986369

What is BMS-986369 used for?

BMS-986369, also known as golcadomide, is an investigational small molecule being studied for relapsed or refractory T-cell lymphomas. It is also being evaluated in healthy participants and in participants with hepatic impairment for drug exposure, metabolism, and safety studies.

What does BMS-986369 target?

BMS-986369 is a small molecule, but its specific molecular target has not been disclosed in the available clinical trial information. The drug is being studied for its effects in relapsed or refractory T-cell lymphomas.

Who makes BMS-986369?

BMS-986369 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety, tolerability, and drug levels in various populations.

What phase is BMS-986369 in?

BMS-986369 is in Phase 1 clinical development. All four of its registered trials are Phase 1 studies, including one active trial in Japan for relapsed or refractory T-cell lymphomas and three completed trials in healthy participants and those with hepatic impairment.

What clinical trials is BMS-986369 in?

BMS-986369 has four Phase 1 trials. NCT05350800 and NCT05567510 study drug exposure and metabolism in healthy participants. NCT06035497, the GOLSEEK-3 study, assesses safety and efficacy in relapsed or refractory T-cell lymphomas in Japan. NCT06535399 evaluates drug levels in hepatic impairment.

Is BMS-986369 the same as golcadomide?

Yes, BMS-986369 is also known as golcadomide. The GOLSEEK-3 trial (NCT06035497) refers to the drug as golcadomide (BMS-986369), confirming that both names refer to the same investigational small molecule.