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BMS-986463

Phase 1

High-grade Serous Ovarian Carcinoma (HGSOC) | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jul 20, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment240

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986463 · 1 trial · 3 indications

Phase 1 1
NCT06476808A Study to Evaluate the Safety, Tolerability, and Efficacy of Escalating Doses of BMS-986463 in Participants With Select Advanced Malignant Tumors.High-grade Serous Ovarian Carcinoma (HGSOC)
RECRUITING240 Analytics
PHASE1RECRUITING
A Study to Evaluate the Safety, Tolerability, and Efficacy of Escalating Doses of BMS-986463 in Participants With Select Advanced Malignant Tumors.
High-grade Serous Ovarian Carcinoma (HGSOC)Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with adverse events (AEs)
Up to 108 weeks
Number of participants with serious adverse events (SAEs)
Up to 108 weeks
Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Up to 108 weeks
Number of participants with AEs leading to discontinuation
Up to 108 weeks
Number of participants with AEs leading to death
Up to 108 weeks

Secondary Endpoints

Maximum observed concentration (Cmax)
Up to 104 weeks
Area under the concentration-time curve (AUC)
Up to 104 weeks
Time of maximum observed concentration (Tmax)
Up to 104 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1: Dose EscalationEXPERIMENTAL -
Arm 2: Dose ExpansionEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986463DRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria * Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1. * Participants must have at least 1 lesion accessible for biopsy in addition to the target lesion, from which a fresh pre treatment biopsy must be obtained. * Participants must have an un...

Countries:United StatesCanadaFranceItalySpain
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Recent Changes (Last 90 Days)

LOWJul 20, 2026NCT06476808lastUpdatePostDate: changed
LOWJul 20, 2026NCT06476808lastUpdatePostDate: changed

Frequently asked questions about BMS-986463

What is BMS-986463 used for?

BMS-986463 is an investigational small molecule being developed for the treatment of high-grade serous ovarian carcinoma (HGSOC). It is also being studied in uterine serous carcinoma and non-small cell lung cancer. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes BMS-986463?

BMS-986463 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, tolerability, and efficacy of this investigational drug.

What phase is BMS-986463 in?

BMS-986463 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies such as the FDA. The drug is currently being evaluated in an early-stage clinical trial to assess its safety, tolerability, and preliminary efficacy.

What clinical trials is BMS-986463 in?

BMS-986463 is being studied in one active clinical trial with the identifier NCT06476808. This Phase 1 study is recruiting participants with select advanced malignant tumors, including high-grade serous ovarian carcinoma, uterine serous carcinoma, and non-small cell lung cancer. The trial is enrolling 240 participants across the United States, Canada, France, Italy, and Spain.

How does BMS-986463 work?

BMS-986463 is a small molecule therapeutic. The specific molecular target of BMS-986463 has not been disclosed in available information. The drug is being evaluated in a controlled clinical trial to determine its mechanism of action and therapeutic potential in treating advanced malignant tumors.

Is BMS-986463 the same as any other drug?

BMS-986463 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is a distinct small molecule being developed by Bristol-Myers Squibb for the treatment of certain advanced cancers, including high-grade serous ovarian carcinoma.