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BMS-906024

Phase 1

Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jan 27, 2020

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment94

FDA Designations

No designations recorded

Clinical trial landscape

BMS-906024 · 2 trials · 3 indications

Phase 1 2
NCT01363817Study to Evaluate the Safety and Tolerability of Weekly Intravenous (IV) Doses of BMS-906024 in Subjects With Acute T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic LymphomaLymphoblastic Leukemia, Acute T-cell
COMPLETED31 Analytics
NCT01292655Study to Evaluate the Safety and Tolerability of IV Doses of BMS-906024 in Subjects With Advanced or Metastatic Solid TumorsCancer
COMPLETED94 Analytics
PHASE1COMPLETED
Study to Evaluate the Safety and Tolerability of Weekly Intravenous (IV) Doses of BMS-906024 in Subjects With Acute T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
Lymphoblastic Leukemia, Acute T-cell
NCT0136381731
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PHASE1COMPLETED
Study to Evaluate the Safety and Tolerability of IV Doses of BMS-906024 in Subjects With Advanced or Metastatic Solid Tumors
Cancer
NCT0129265594
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Study Endpoints

Primary Endpoints

Number of subjects with adverse events as a measure of safety and tolerability
Weekly assessments until study discontinuation due to disease progression or unacceptable adverse events as well as an assessment 30 days after treatment discontinuation with an average time on study expected to be < 1 year.

Secondary Endpoints

Disease assessments in bone marrow & by computed tomography (CT)/ magnetic resonance imaging (MRI)
Disease assessments at least every 8 weeks during treatment
Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: maximum observed concentration (Cmax)
Pharmacokinetics at multiple time points during the first 4 weeks of dosing
Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: minimum observed concentration (Cmin)
Pharmacokinetics at multiple time points during the first 4 weeks of dosing
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Escalation Phase: BMS-906024EXPERIMENTALBMS-906024 escalating doses starting at 0.3 mg solution for intravenous (IV) administration once weekly continuously until disease progression or unacceptable toxicity
Expansion Phase: BMS-906024 + DexamethasoneEXPERIMENTALBMS-906024 maximum tolerated dose (To be determined) solution for IV administration once weekly and Dexamethasone 20mg/day tablet by mouth (Oral) for 3-4 days every week for 3-4 weeks per cycle continuously until disease progression or unacceptable toxicity
Arm A1 (Escalation): BMS-906024EXPERIMENTALBMS-906024 solution intravenously as specified
Arm A2 (Expansion): BMS-906024EXPERIMENTALBMS-906024 solution intravenously as specified
Arm B1 (Escalation): BMS-906024EXPERIMENTALBMS-906024 solution intravenously as specified
Arm B2 (Expansion): BMS-906024EXPERIMENTALBMS-906024 solution intravenously as specified

Interventions

NameTypeDescription
BMS-906024DRUG -
DexamethasoneDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Subjects with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma refractory to or relapsed from standard therapies * Life expectancy of at least 2 months *...

Countries:United StatesFranceGermanyAustraliaCanada
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Competitive Landscape -Cancer 5 trials

CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520/ GEH200521- Part A
Zimmer Biomet Holdings, Inc.ZBH1 - Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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Frequently asked questions about BMS-906024

What is BMS-906024 used for?

BMS-906024 is an investigational small molecule being studied for the treatment of cancer, including advanced or metastatic solid tumors, and acute T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma. It is in Phase 1 clinical development and is not yet approved by the FDA.

Who makes BMS-906024?

BMS-906024 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational drug in patients with certain types of cancer.

What phase is BMS-906024 in?

BMS-906024 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Two Phase 1 trials have been completed, one in advanced or metastatic solid tumors and another in acute T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma.

What clinical trials is BMS-906024 in?

BMS-906024 has been studied in two completed Phase 1 clinical trials. NCT01292655 evaluated the safety and tolerability of intravenous doses in 94 subjects with advanced or metastatic solid tumors. NCT01363817 evaluated weekly intravenous doses in 31 subjects with acute T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma.

Is BMS-906024 the same as any other drug?

No alternative names for BMS-906024 have been reported. It is identified solely by its investigational code name BMS-906024 in clinical trial registries and scientific literature. The drug is a small molecule being developed by Bristol-Myers Squibb for oncology indications.