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

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