An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies

Key Inclusion Criteria:

- Confirmed diagnosis of advanced malignancy:

- Treatment Group A (TGA): Part 1 and Part 2: Any advanced solid tumor or lymphoma;
Part 3: Histologically confirmed disease in specific solid tumors and lymphomas

- Treatment Group B (TGB): Acute Leukemia (Part 3 - acute myeloid leukemia [AML]
only), myelodysplastic syndrome (MDS), myelodysplastic /myeloproliferative
neoplasms (MDS/MPN) and myelofibrosis (MF)

- Treatment Group C (TGC): Multiple myeloma

- Progressed following at least 1 line of prior therapy and there is no further approved
therapy available that has been demonstrated to prolong survival (including subjects
who are intolerant to the approved therapy)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 in Parts 1 and
2 dose escalation and titration, and 0, 1, 2 in Part 3 dose expansion

Key Exclusion Criteria:

- Inadequate hematopoietic, liver, endocrine or renal function

- Receipt of anticancer medications or investigational drugs within the following
interval before the first administration of study drug:

- < 6 weeks for mitomycin-C or nitrosoureas

- < 5 half-lives or 14 days, whichever is longer, for any investigational agent
(for any indication)

- < 28 days for any antibodies or biological therapies

- < 5 half-lives for all other anticancer medications, or sponsor approval

- Prior radiotherapy within 2 weeks prior to first dose of study drug

- Untreated brain or central nervous system (CNS) metastases

- Type 1 diabetes or uncontrolled Type 2 diabetes

- Any sign of clinically significant bleeding