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