Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies

Prior treatment

• B-cell lymphoma patients who have received prior allogeneic stem cell transplant
• Patient have received anti-cancer therapies within defined time frames prior to the first dose of study treatment
• Symptomatic central nervous system (CNS) involvement which are neurologically unstable or requiring increasing doses of steroids to control.

Other illness

• Other malignant diseases than the ones being treated in this study
• 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.

Lab values

• Patient having out of range laboratory values defined as:
• 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

Other

• Insufficient bone marrow function at screening:

• Eastern Cooperative Oncology Group (ECOG): 0 to 2
• Relapsed or refractory diffuse large B cell lymphoma with measurable disease as determined by Non-Hodgkin's Lymphoma Cheson response criteria (2014)
• Advanced or recurrent/metastatic solid tumor, including nasopharyngeal carcinoma, castration-resistant prostate cancer, gastric cancer, ovarian clear cell carcinoma and sarcoma, with measurable disease as determined by RECIST 1.1.