An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced Malignancies

Inclusion Criteria:

Phase 1a

Aged 18 years or older
Histologically or cytologically confirmed solid tumor or hematologic malignancy
Life expectancy of 12 weeks or longer
Must have received ≥ 1 prior treatment regimen
Must not be a candidate for potentially curative or standard of care approved therapy

Phase 1b

Aged 18 years or older
Cohort A: Histologically or cytologically confirmed pancreatic adenocarcinoma, triple-negative breast cancer, urothelial cancer with at least 1 measurable or evaluable target lesion
Cohorts B, C, D, E and G: Histologically confirmed multiple myeloma and measureable/evaluable disease
Cohort F: Confirmed acute myeloid leukemia or myelodysplastic syndrome
Cohort H: Individuals diagnosed with lymphoma

Prior therapy:

Cohort A: No more than 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy)
Cohorts B, C, D, E and G: Must have relapsed from or have been refractory to ≥ 2 prior treatment regimens
Cohort F: May have received any number of prior treatment regimens or be treatment-naïve
Cohort H: Must have relapsed from or have been refractory to available treatments

Phase 2

Aged 18 years or older
Cohorts I and J: Confirmed acute myeloid leukemia or high risk myelodysplastic syndrome

Prior therapy:

Cohorts I and J: Must have failed prior therapy with a hypomethylating agent (HMA)

Exclusion Criteria:

Prior receipt of a JAK1 inhibitor (Phase 1a only)
Known active central nervous system metastases and/or carcinomatous meningitis
Eastern Cooperative Oncology Group (ECOG) performance status > 2
Any known contraindications to the use of gemcitabine, nab-paclitaxel, dexamethasone, carfilzomib, bortezomib, lenalidomide, azacitidine, pomalidomide or PI3Kδ inhibitor (Phase 1b and Phase 2 only, as appropriate to treatment cohort)
Known human immunodeficiency virus infection, or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation