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BMS-986406

Phase 1

Advanced Cancer | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: Sep 26, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment77

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986406 · 1 trial · 1 indication

Phase 1 1
NCT05298592A Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced TumorsAdvanced Cancer
COMPLETED77 Analytics
PHASE1COMPLETED
A Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Tumors
Advanced CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with adverse events (AEs)
Up to 100 days
Number of participants with serious adverse events (SAEs)
Up to 100 days
Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Up to 28 days
Number of participants with AEs leading to discontinuation
Up to 100 days
Number of participants with death
Up to 100 days

Secondary Endpoints

Maximum observed plasma concentration (Cmax)
Up to 14 days
Time of maximum observed plasma concentration (Tmax)
Up to 14 days
Trough observed plasma concentration (Ctrough)
Up to 14 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1A: BMS-986406 (Monotherapy Dose Escalation)EXPERIMENTAL -
Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation)EXPERIMENTAL -
Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion)EXPERIMENTAL -
Part 2: BMS-986406 + Nivolumab (Expansion Cohorts)EXPERIMENTAL -
Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or PaclitaxelEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986406BIOLOGICALSpecified dose on specified days
NivolumabBIOLOGICALSpecified dose on specified days
CarboplatinDRUGSpecified dose on specified days
PemetrexedDRUGSpecified dose on specified days
PaclitaxelDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites29

Inclusion Criteria: Parts 1A, 1B, 1C: * Histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent malignant tumor. Eligible tumor types are non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastr...

Countries:United StatesArgentinaBelgiumJapanSouth KoreaSpain
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Competitive Landscape -Cancer 5 trials (matched to "Advanced Cancer")

Frequently asked questions about BMS-986406

What is BMS-986406 used for?

BMS-986406 is an investigational monoclonal antibody being studied for the treatment of advanced cancer. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities. The drug is being evaluated as a potential therapy for patients with advanced tumors.

Who makes BMS-986406?

BMS-986406 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded 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 drug in patients with advanced cancer.

What phase is BMS-986406 in?

BMS-986406 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied for the treatment of advanced cancer, and its safety and effectiveness are still being evaluated in clinical trials.

What clinical trials is BMS-986406 in?

BMS-986406 has been studied in one clinical trial, identified as NCT05298592, titled "A Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Tumors." This Phase 1 trial has been completed and enrolled 77 participants with advanced cancer across the United States, Argentina, Belgium, Japan, South Korea, and Spain.

Is BMS-986406 FDA approved?

BMS-986406 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of advanced cancer. The drug has not yet completed the clinical trials and regulatory review process required for approval, and its safety and efficacy are still being evaluated.