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BMS-986360

Phase 2

Advanced Solid Tumors | Small molecule | Oncology |Bristol-Myers Squibb Company|Trials Updated: Jun 13, 2025

BMS-986360 development status

Highest phase Phase 2 (NCT03142191)
Phase scored for BMYPhase 1
Registered trials 9 across 3 sponsors since Apr 2014

BMS-986360 target and mechanism

ModalitySmall molecule

Also known as CC-90001

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials3
Total Enrollment126

FDA Designations

No designations recorded

BMS-986360 clinical trials

BMS-986360 · 3 trials · 3 indications

Phase 1 3
NCT05625412A Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid TumorsAdvanced Solid Tumors
COMPLETED70 Analytics
NCT03742882A Study to Assess the Pharmacokinetics of CC-90001 in Subjects With Mild, Moderate, and Severe Hepatic Impairment Compared With Healthy SubjectsHepatic Impairment
COMPLETED40 Analytics
NCT02510937Safety and PK Study of CC-90001 in Subjects With Pulmonary FibrosisPulmonary Fibrosis
COMPLETED16 Analytics
PHASE1COMPLETED
A Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors
Advanced Solid TumorsUnlock trial analytics
PHASE1COMPLETED
A Study to Assess the Pharmacokinetics of CC-90001 in Subjects With Mild, Moderate, and Severe Hepatic Impairment Compared With Healthy Subjects
Hepatic ImpairmentUnlock trial analytics
PHASE1COMPLETED
Safety and PK Study of CC-90001 in Subjects With Pulmonary Fibrosis
Pulmonary FibrosisUnlock 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 Dose-Limiting Toxicities (DLTs)
Up to approximately 2 years
Number of participants with AEs leading to discontinuation
Up to approximately 2 years
Number of deaths
Up to approximately 2 years
Pharmacokinetic- AUC0-t
UP to approximately 7 Days

Estimation of AUC calculated from time zero to the last measured time point

Pharmacokinetic- AUC0-∞
UP to approximately 7 Days

Estimation of AUC calculated from time zero to infinity

Pharmacokinetic- Cmax
UP to approximately Day 1

Estimation of observed maximum plasma concentration

Pharmacokinetic- Tmax
UP to approximately Day 1

Estimation of time to Cmax

Pharmacokinetic- t1/2
Up to approximately 7 days

Estimation of terminal elimination half-life

Pharmacokinetic- CL/F
Up to approximately 7 days

Estimation of apparent clearance of drug from plasma after extravascular administration

Pharmacokinetic- Vz/F
Up to approximately 7 days

Estimation of apparent volume of distribution during the terminal phase

Adverse Events (AEs)
up to 16 weeks

Number of subjects with adverse events

Dose interruptions, reductions, and discontinuation
up to 16 weeks

Number of subjects experiencing dose interruptions, reductions, and discontinuation of CC-90001 secondary to an AE

Complete PEs
up to 16 weeks

Complete Physical Examinations

Clinical laboratory assessments
up to 16 weeks
Vital sign measurements
up to 16 weeks

Heart rate (HR), respiratory rate, blood pressure (BP), and body temperature

12-lead ECGs
up to 16 weeks
Urine pregnancy tests
up to 16 weeks
Concomitant medications and procedures
up to 16 weeks

Secondary Endpoints

Maximum observed plasma concentration (Cmax)
Up to approximately 2 years
Time of maximum observed plasma concentration (Tmax)
Up to approximately 2 years
Area under the plasma concentration-time curve (AUC)
Up to approximately 2 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BMS-986360EXPERIMENTAL -
BMS-986360 + DocetaxelEXPERIMENTAL -
BMS-986360 + NivolumabEXPERIMENTAL -
BMS-986360 + CapecitabineEXPERIMENTAL -
Administration of CC-90001EXPERIMENTALSingle oral dose of 200 mg of CC-90001
Low dose CC-90001EXPERIMENTALLow dose (100 mg) CC-90001 administered orally once daily (QD) for 12 continuous weeks
High dose CC-90001EXPERIMENTALHigh-dose (200 mg) CC-90001 administered orally Once Daily (QD) for 12 continuous weeks

Interventions

NameTypeDescription
BMS-986360DRUGSpecified dose on specified days
DocetaxelDRUGSpecified dose on specified days
NivolumabDRUGSpecified dose on specified days
CapecitabineDRUGSpecified dose on specified days
CC-90001DRUGCC-90001
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites35

Inclusion Criteria: * Participants in Part 1 must have histologic or cytologic confirmation of non-small cell lung cancer (NSCLC), metastatic triple negative breast cancer (mTNBC), squamous cell carcinoma of head and neck (SCCHN), pancreatic adenocarcinoma (PAAD), renal cell carcinoma (RCC), micros...

Countries:United StatesArgentinaAustraliaCanadaChileFranceItalyMexicoSpain
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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about BMS-986360

What is BMS-986360 used for?

BMS-986360 is an investigational small molecule being studied in adults with advanced solid tumors. It is being evaluated both as a single agent and in combination with chemotherapy or nivolumab. It is not approved for any indication and remains in clinical development.

Who is developing BMS-986360?

BMS-986360 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is the sponsor of the clinical program evaluating the compound in advanced solid tumors.

What phase is BMS-986360 in?

BMS-986360 is in Phase 1 clinical development. The single registered trial, NCT05625412, is a Phase 1 study that has been completed. The drug is investigational and has not been approved by the FDA for any use.

What clinical trials is BMS-986360 in?

BMS-986360 has been studied in one clinical trial, NCT05625412, titled A Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors. The Phase 1 trial enrolled 70 participants across the United States, Argentina, Australia, Canada, Chile, France, Italy, Mexico, and Spain, and is completed.

Is BMS-986360 the same as CC-90001?

Yes. BMS-986360 is also known as CC-90001, and the two names refer to the same investigational compound. The Phase 1 trial NCT05625412 lists the drug under both designations in its title.

Is BMS-986360 FDA approved?

No. BMS-986360 is an investigational drug in Phase 1 clinical development and has not received FDA approval. Its only registered trial, NCT05625412, has been completed, and the compound remains under study for advanced solid tumors.