A Multicenter, Open-Label, Phase I Study Evaluating the Safety and Tolerability of Intravenous Pegaspargase in Combination With Intravenous Gemcitabine HCl in the Treatment of Advanced and/or Metastatic Solid Tumors and Lymphoma

Inclusion Criteria:

- Capable of understanding the protocol requirements and risks and providing written
informed consent.

- Histologically or cytologically confirmed diagnosis of advanced and/or metastatic
solid tumor or lymphoma (Hodgkin's or non-Hodgkin's), and have either failed primary
treatment or there is no available standard treatment.

- Prior standard therapy was not effective, or no known therapy will extend survival or
provide benefit.

- Measurable or evaluable disease.

- Age 18 years or older.

- Score of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale.

- Absolute neutrophil count (ANC)≥ 1500/μL.

- Platelet count ≥ 100,000/μL.

- Hemoglobin ≥ 9.0 g/dL.

- Fibrinogen ≥ 0.75x the lower limit of normal (LLN), and PT, PTT, and INR ≤ 1.5x the
upper limit of normal (ULN).

- Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min.

- Total bilirubin ≤ 1.5 mg/dL.

- Transaminases (AST, ALT) ≤ 2.5x the upper limit of normal (ULN) (may be ≤ 5.0x ULN if
due to metastatic disease in the liver).

- Amylase and lipase levels are within normal limits.

Any subject who has given informed consent to participate in the clinical study and who
meets all entry criteria for the study may participate in the tumor analysis part of the
study.

Exclusion Criteria:

- Subjects meeting any of the following exclusion criteria will not be eligible for
enrollment.

- Concurrent serious medical illness that could potentially interfere with protocol
compliance.

- Has pancreatitis or a history of pancreatitis, not related to pancreatic cancer.

- Has a coagulopathy or a history of coagulopathy.

- Known chronic infectious disease, such as AIDS or hepatitis (screening for hepatitis
and HIV will not be performed).

- Positive screening pregnancy test or is breast-feeding.

- Female or male subject of reproductive capacity unwilling to use methods appropriate
to prevent pregnancy during the course of this protocol.

- Known or clinically suspected active brain metastases.

- Received pegaspargase (Oncaspar®, PEG-L-asparaginase) or any asparaginase or
asparaginase-containing drug, at any time prior to this study.

- Received prior chemotherapy, immunotherapy or an investigational agent regimen