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

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