Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies
About the study
The study will be conducted in three parts. Part 1 is a dose escalation phase to determine the maximum tolerated dose (MTD) of INCB040093, a PI3Kδ inhibitor, or a tolerated, pharmacologically active dose; Part 2 will evaluate the combination of INCB040093 and itacitinib (INCB039110), a JAK1 inhibitor, to determine the MTD of the combination or a tolerated dose that produces substantial pharmacologic inhibition of both targets; Part 3 will further evaluate the chosen doses of INCB040093 alone and in combination with itacitinib (INCB039110) in subjects with relapsed/refractory B-cell malignancies.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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 CLL and rare non-Hodgkin's B-cell subtypes such as Hairy Cell Leukemia, Waldenstrom macroglobulinemia, Mantle cell lymphoma, transformed NHL histologies, etc.
*Hodgkin's lymphoma
- Life expectancy of 12 weeks or longer.
- Subject must have received ≥ 1 prior treatment regimen.
- The subject must not be a candidate for potentially curative therapy, including stem cell transplant.
EXCLUSION CRITERIA
Exclusion Criteria:
- Received an investigational study drug within 28 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study drug.
- Received any approved anticancer medications within 21 days or 5 half-lives (whichever is longer) prior to receiving their first dose of study drug (42 days for nitrosoureas) EXCEPT steroids at ≤ 10 mg prednisone daily (or equivalent).
- Has any unresolved toxicity ≥ Grade 2 from previous anticancer therapy.
- Has history of brain metastases or spinal cord compression, or lymphoma involving the central nervous system.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 3.
- Received allogeneic hematopoietic stem cell transplant within the last 6 months, or has active graft versus host disease (GVHD) following allogeneic transplant, or is currently receiving immunosuppressive therapy following allogeneic transplant.
- Received autologous hematopoietic stem cell transplant within the last 3 months.
- Laboratory parameters not within the protocol-defined range.
- Current or recent history (<30 days prior to screening and/or <45 days prior to dosing) of a clinically meaningful bacterial, fungal, parasitic or mycobacterial infection.
- Current clinically active viral infection.
- Known history of infection with the human immunodeficiency virus (HIV).
- History of active hepatitis or positive serology for hepatitis.

Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
B-cell Malignancies
Age (in years)
18+
Phase
Phase 1
Participants needed
121
Est. Completion Date
Feb 3, 2024
Treatment type
Interventional
Sponsor
Incyte Corporation
ClinicalTrials.gov identifier
NCT01905813
Study number
INCB 40093-102
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?