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INCB040093

Phase 1

B-cell Malignancies | Small molecule | Oncology |Incyte Corporation|Last Updated: May 11, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment121

FDA Designations

No designations recorded

Clinical trial landscape

INCB040093 · 1 trial · 1 indication

Phase 1 1
NCT01905813Study of INCB040093 in Subjects With Previously Treated B-Cell MalignanciesB-cell Malignancies
COMPLETED121 Analytics
PHASE1COMPLETED
Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies
B-cell MalignanciesUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of INCB040093 as monotherapy and when given in combination with itacitinib as determined by clinical laboratory assessments, physical exams, 12-lead ECG and summary of adverse events
Measured every 3 weeks until progression.

Secondary Endpoints

Preliminary efficacy as assessed by Overall Response Rate (ORR) as measured by published criteria for Hodgkin's/non-Hodgkin's lymphoma (Cheson et al 2007 and Owen et al 2013) and Chronic Lymphocytic Leukemia (CLL) (Cheson et el 2012)
Every 12 weeks (4 cycles) until study withdrawal
Pharmacokinetic (PK) collections.
Measured for each patient at Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 1 Day 15
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
INCB040093EXPERIMENTAL -
INCB040093 in combination with itacitinib (INCB039110)EXPERIMENTAL -

Interventions

NameTypeDescription
INCB040093DRUGEscalating doses starting at 100 mg every day (QD)
INCB040093 + itacitinibDRUGINCB040093 dose to be determined at completion of Part 1 of the study + itacitinib at a starting dose of 400 mg, QD with escalations planned up to 600 mg QD.
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Eligibility Criteria

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

Inclusion Criteria: • Aged 18 years or older, with lymphoid malignancies of B-cell origin as follows: \*Indolent / aggressive B-cell (NHL) Non- Hodgkin's Lymphoma: EXCLUDING: Burkitt lymphoma and precursor B-lymphoblastic leukemia/lymphoma INCLUDING: any non-Hodgkin's B-cell malignancy such as C...

Countries:United States
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Recent Changes (Last 90 Days)

MEDIUMJun 11, 2026NCT01905813TRIAL_REMOVED: changed
MEDIUMJun 11, 2026NCT01905813TRIAL_REMOVED: changed
MEDIUMJun 11, 2026NCT01905813TRIAL_REMOVED: changed

Frequently asked questions about INCB040093

What is INCB040093 used for?

INCB040093 is an investigational small molecule being studied for the treatment of B-cell malignancies, a type of cancer that affects white blood cells called B lymphocytes. It is intended for patients with previously treated B-cell malignancies, meaning those whose disease has not responded to or has relapsed after prior therapy.

Who makes INCB040093?

INCB040093 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. Incyte is conducting clinical research to evaluate the safety and efficacy of this investigational drug in patients with B-cell malignancies.

What phase is INCB040093 in?

INCB040093 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being tested in clinical trials to assess its safety, tolerability, and potential efficacy in patients with B-cell malignancies.

What clinical trials is INCB040093 in?

INCB040093 has been studied in one completed Phase 1 clinical trial with the identifier NCT01905813. This trial, titled 'Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies,' enrolled 121 participants in the United States. The study was not randomized or double-blind and included a control group.

How does INCB040093 work?

INCB040093 is a small molecule, but its specific molecular target has not been disclosed in available information. As an investigational oncology drug, it is being studied for its potential to interfere with pathways involved in the growth and survival of malignant B cells, though the exact mechanism of action is not publicly detailed.