Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies

Exclusion Criteria

• •1. Other malignant diseases than the ones being treated in this study
• •2. Severe and/or uncontrolled medical conditions that in the investigator's opinion could affect the safety of individual or impair the assessment of study result.
• •3. B-cell lymphoma patients who have received prior allogeneic stem cell transplant
• •4. Patient have received anti-cancer therapies within defined time frames prior to the first dose of study treatment
• •5. Symptomatic central nervous system (CNS) involvement which are neurologically unstable or requiring increasing doses of steroids to control.
• •6. Patient having out of range laboratory values defined as:
• •1\) Insufficient bone marrow function at screening:
• •Platelets ≤ 50,000/mm3
• •Hemoglobin (Hgb) ≤ 80 g/L
• •Absolute neutrophil count (ANC) ≤ 1000/mm3 2) Insufficient hepatic and renal function at screening:
• •ALP, ALT, and AST \> 3 x ULN (\>5 x ULN if subject has liver metastases)
• •Total bilirubin \>1.5 x ULN
• •Serum creatinine \> 1.5 x ULN and/or creatinine clearance ≤ 50 mL/min