Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies

Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of relapsed or refractory advanced or metastatic malignancies:

Part 1: solid tumors or lymphomas, or hematologic malignancies
Part 2: histologically confirmed disease in specific tumor types
Part 3: advanced solid tumor or hematologic malignancy
Part 4: select advanced solid tumor or hematologic malignancy
For Part 1 and 2, subjects must have progressed following at least 1 line of prior therapy and there is no further established therapy that is known to provide clinical benefit (including subjects who are intolerant to the established therapy)
For Parts 3 and 4, subjects must have progressed following at least 1 line of prior therapy, and the treatment with the select SOC agent is relevant for the specific disease cohort.
Life expectancy > 12 weeks, for MF subjects in Parts 3 and 4, life expectancy > 24 weeks

Eastern Cooperative Oncology Group (ECOG) performance status

Parts 1 and 3: 0 or 1
Parts 2 and 4: 0, 1, or 2
Willingness to avoid pregnancy or fathering children

Exclusion Criteria:

Inadequate bone marrow function per protocol-specified hemoglobin, platelet count, and absolute neutrophil count
Inadequate organ function per protocol-specified total bilirubin, AST and ALT, creatinine clearance and alkaline phosphatase.
Receipt of anticancer medications or investigational drugs within protocol-specified intervals
Unless approved by the medical monitor, may not have received an allogeneic hematopoietic stem cell transplant within 6 months before treatment, or have active graft-versus-host-disease following allogeneic transplant
Unless approved by the medical monitor, may not have received autologous hematopoietic stem cell transplant within 3 months before treatment
Any unresolved toxicity ≥ Grade 2 (except stable Grade 2 peripheral neuropathy or alopecia) from previous anticancer therapy
Radiotherapy within the 2 weeks before initiation of treatment. Palliative radiation treatment to nonindex or bone lesions performed less than 2 weeks before treatment initiation may be considered with medical monitor approval
Currently active and uncontrolled infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment
Untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed
History or presence of abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful
Type 1 diabetes or uncontrolled Type 2 diabetes
HbA1c of ≥ 8% (all subjects will have HbA1c test at screening)
Any sign of clinically significant bleeding
Coagulation panel within protocol-specified parameters