Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies

The purpose phase I of this trial is to characterize safety and tolerability and determine
the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of MAK683.

The purpose of the phase II of this trial will be to evaluate the anti-tumor activity of
MAK683.

Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG): 0 to 2

2. Relapsed or refractory diffuse large B cell lymphoma with measurable disease as
determined by Non-Hodgkin's Lymphoma Cheson response criteria (2014)

3. 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.

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