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BMS-986497

Phase 1

Acute Myeloid Leukemia | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Apr 8, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment105

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986497 · 1 trial · 2 indications

Phase 1 1
NCT06419634Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double and Triple Combination With Azacitidine and Venetoclax in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic SyndromeAcute Myeloid Leukemia
RECRUITING105 Analytics
PHASE1RECRUITING
Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double and Triple Combination With Azacitidine and Venetoclax in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
Acute Myeloid LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of dose-limiting toxicities (DLTs)
Up to 21 days
Incidence of treatment-emergent adverse events (TEAEs)
Up to 2 years
Determine the Recommended Phase 2 Dose (RP2D) of BMS-986497 as Monotherapy
Up to 2 years
RP2D of BMS-986497 as Combination Therapy
Up to 2 years

The combination therapy included BMS-986497 and Azacitidine

RP2D of BMS-986497 as Triple Combination Therapy
Up to 2 years

The triple combination therapy included BMS-986497, Azacitidine and Venetoclax.

Secondary Endpoints

Maximum concentration (Cmax)
Up to 2 years
Time to reach Cmax (Tmax)
Up to 2 years
Area under the curve from time 0 to last quantifiable concentration (AUC0-last)
Up to 2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Dose Escalation BMS-986497 (Monotherapy)EXPERIMENTAL -
Part 2, Cohort A: Dose Expansion BMS-986497 (Combination Therapy)EXPERIMENTAL -
Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy)EXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986497DRUGSpecified dose on specified days
AzacitidineDRUGSpecified dose on specified days
VenetoclaxDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Adults with primary or secondary relapsed and/or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). * Detectable levels of cluster of differentiation 33 (CD33) expression. * Failed alternative therapies with established benefit. * Eastern Cooperative On...

Countries:United StatesCanadaFranceSpain
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Frequently asked questions about BMS-986497

What is BMS-986497 used for?

BMS-986497 is an investigational small molecule being developed for the treatment of Acute Myeloid Leukemia (AML). It is also being studied in Myelodysplastic Syndrome (MDS). The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes BMS-986497?

BMS-986497 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with certain blood cancers.

What phase is BMS-986497 in?

BMS-986497 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 ongoing Phase 1 trial is currently recruiting participants to evaluate the drug as a treatment for Acute Myeloid Leukemia and Myelodysplastic Syndrome.

What clinical trials is BMS-986497 in?

BMS-986497 is being studied in a Phase 1 clinical trial with the identifier NCT06419634. This trial is evaluating the drug as a monotherapy and in combination with azacitidine and venetoclax in patients with relapsed or refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study is recruiting participants in the United States, Canada, France, and Spain.

Is BMS-986497 the same as ORM-6151?

Yes, BMS-986497 is also known as ORM-6151. The clinical trial NCT06419634 refers to the drug as BMS-986497 (ORM-6151), indicating that both names refer to the same investigational compound being developed by Bristol-Myers Squibb.