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BMS-986301

Phase 1

Advanced Solid Cancers | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Feb 19, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03956680An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid CancersPHASE1 COMPLETED 54 — — Mar 26, 2019Apr 24, 2024Feb 19, 20255 United States, Canada
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Study Endpoints
Primary Endpoints
Incidence of dose-limiting toxicity (DLTs)
Cycle 1 (28 days)
Incidence of adverse events (AEs)
From Baseline until study exit (up to approximately 2 years)
Incidence of serious adverse events (SAEs)
From Baseline until study exit (up to approximately 2 years)
Incidence of AEs leading to discontinuation
From Baseline until study exit (up to approximately 2 years)
Incidence of deaths
From Baseline until study exit (up to approximately 2 years)
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
From Baseline until disease progression (approximately 2 years)
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
From Baseline until disease progression (approximately 2 years)
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
From Baseline until disease progression (approximately 2 years)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM)EXPERIMENTAL -
Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-studyEXPERIMENTAL -
Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-studyEXPERIMENTAL -
Part 1B Group 4: Systemic BMS-986301 + Nivolumab + IpilimumabEXPERIMENTAL -
Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + IpilimumabEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986301DRUGSpecified dose on specified days
NivolumabBIOLOGICALSpecified dose on specified days
IpilimumabBIOLOGICALSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Histologically or cytologically confirmed advanced unresectable/metastatic malignancy of the squamous cell carcinoma of the head and neck (HNSCC), non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), triple negative breast cancer (TNBC), and urothelial car...

Countries:United StatesCanada
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