INCB040093 + Itacitinib for B-Cell Lymphoma

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Incyte Corporation

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults with B-cell lymphoma or other B-cell malignancies who have tried at least one treatment and aren't eligible for curative therapies like stem cell transplants. They should be in a condition to live at least 12 more weeks, not have brain involvement by cancer, and can't be recovering from recent cancer treatments or active infections.

Inclusion Criteria

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.

+3 more

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.

+9 more

Participant Groups

The trial is testing INCB040093 alone and combined with itacitinib on people with B-cell cancers. It has three parts: finding the safest dose of INCB040093, then its combination with itacitinib, and finally evaluating these doses in patients whose disease returned after treatment.

2Treatment groups

Experimental Treatment

Group I: INCB040093 in combination with itacitinib (INCB039110)Experimental Treatment1 Intervention

Group II: INCB040093Experimental Treatment1 Intervention