Clinical trial · Interventional
Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies
A Phase 1, Open-label, Dose Escalation, Safety and Tolerability Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| INCB040093 | Drug | — | UNRESOLVED |
| INCB040093 + itacitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- INCB040093
- interventionNames
- Drug: INCB040093
- type
- EXPERIMENTAL
- label
- INCB040093 in combination with itacitinib (INCB039110)
- interventionNames
- Drug: INCB040093 + itacitinib
Primary outcomes (1)
- measure
- 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
- timeFrame
- Measured every 3 weeks until progression.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: * 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.
References
Publications (1)
- DERIVEDPhillips TJ, Forero-Torres A, Sher T, Diefenbach CS, Johnston P, Talpaz M, Pulini J, Zhou L, Scherle P, Chen X, Barr PM. Phase 1 study of the PI3Kdelta inhibitor INCB040093 +/- JAK1 inhibitor itacitinib in relapsed/refractory B-cell lymphoma. Blood. 2018 Jul 19;132(3):293-306. doi: 10.1182/blood-2017-10-812701. Epub 2018 Apr 25. PMID 29695516