A Phase I, Multicenter Study of MRX34 Given Intravenously Two Times Per Week for Three Weeks, Repeated Every Four Weeks in Patients With Unresectable Primary Liver Cancer or Advanced or Metastatic Cancer With Liver Involvement

Inclusion Criteria:

1. Aged ≥ 18 years

2. Patients with histologically confirmed unresectable primary liver cancer or advanced
metastatic cancer with liver metastasis including lymphoma

3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

4. Acceptable liver function:

- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN)

- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline
phosphatase (ALP) ≤ 5 x ULN.

5. Acceptable renal function:

• Serum creatinine ≤ 1.5 times the ULN, or calculated creatinine clearance ≥ 60
mL/min/1.73 m2 for patients with creatinine levels above the institutional normal

6. Acceptable hematological status:

- Absolute Neutrophil Count (ANC) ≥ 1500 cells/mm3

- Platelet count ≥ 100,000 plts/mm3 (without transfusion)

- Hemoglobin ≥ 9 g/dL

7. Prothrombin time (PT) or International Normalized Ratio (INR) ≤ 1.25 x ULN.

Exclusion Criteria:

1. New York Heart Association (NYHA) Class III or IV cardiac disease, myocardial
infarction within the past 6 months, unstable and/or symptomatic arrhythmia, or
evidence of ischemia on ECG.

2. Active, uncontrolled bacterial, viral, or fungal infections requiring systemic
therapy.

3. Pregnant or nursing women.

4. Known infection with human immunodeficiency virus (HIV).

5. Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other
conditions) that could compromise protocol objectives in the opinion of the
investigator and/or the sponsor.

6. Patients with recent history of hemorrhage and patients predisposed to hemorrhage due
to coagulopathies or structural anomalies.

7. Patients who require treatment with therapeutic doses of coumarin-type anticoagulants
(maximum daily dose of 1mg allowed for port line patency permitted).

8. Patients with cirrhosis classed as Child-Pugh B or C.

9. Patients receiving any platelet-inhibiting drugs.