INCB040093 + Itacitinib for B-Cell Lymphoma

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Incyte Corporation

Must not be taking: Anticancer medications

Disqualifiers: Brain metastases, CNS lymphoma, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

121 Participants Needed

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.

Research Team

Peter Langmuir, MD

Principal Investigator

Incyte Corporation

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

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

8 weeks

Combination Evaluation

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

8 weeks

Further Evaluation

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

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• INCB040093
• itacitinib

Trial Overview 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.

Participant Groups

Group I: INCB040093 in combination with itacitinib (INCB039110) Experimental Treatment 1 Intervention

Group II: INCB040093 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School