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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

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986301 · 1 trial · 1 indication

Phase 1 1
NCT03956680An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid CancersAdvanced Solid Cancers
COMPLETED54 Analytics
PHASE1COMPLETED
An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers
Advanced Solid Cancers
NCT0395668054
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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 to 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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Frequently asked questions about BMS-986301

What is BMS-986301 used for?

BMS-986301 is an investigational small molecule being studied for the treatment of advanced solid cancers. It is being evaluated alone or in combination with other immunotherapies in patients with advanced solid tumors. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes BMS-986301?

BMS-986301 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational oncology drug in patients with advanced solid cancers.

What phase is BMS-986301 in?

BMS-986301 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development for the treatment of advanced solid cancers.

What clinical trials is BMS-986301 in?

BMS-986301 has one completed Phase 1 clinical trial registered under NCT03956680. The study evaluated BMS-986301 alone or in combination with nivolumab and ipilimumab in participants with advanced solid cancers. The trial enrolled 54 patients in the United States and Canada.

How does BMS-986301 work?

BMS-986301 is a small molecule immunomodulator designed to enhance the body's immune response against cancer cells. It is being studied in combination with checkpoint inhibitors such as nivolumab and ipilimumab to potentially improve anti-tumor activity in patients with advanced solid tumors.