Study of PEGPH20 With Initial Dexamethasone Premedication Given Intravenously to Patients With Advanced Solid Tumors

A study of PEGylated recombinant human hyaluronidase (PEGPH20) administered on a twice
weekly schedule for 28 days followed by a weekly dosing schedule in patients with advanced
solid tumors who have either failed to respond to standard therapy or for whom no standard
therapy exists.

Inclusion Criteria:

- Written, signed, IRB-approved informed consent form.

- Pathologic (histologic or cytologic) confirmation of metastatic or locally advanced
solid tumor.

- Patients must have a pathologically documented, definitively diagnosed, advanced
solid tumor that is refractory to standard treatment, for which no standard therapy
is available or the patient refuses standard therapy.

- One or more tumors measurable by RECIST criteria.

- Karnofsky performance status ≥ 70%.

- Ejection fraction ≥ 50%, determined by echocardiogram.

- Life expectancy at least 3 months.

- Age ≥ 18 years.

- Acceptable organ function; normal hepatic, renal and hematopoietic function.

- Negative serum or urine pregnancy test result in women of childbearing potential.

Exclusion Criteria:

- Known brain metastasis.

- New York Heart Association Class III or IV cardiac disease, myocardial infarction
within 6 months of enrollment, or cardiac arrhythmia requiring medical therapy.

- Active, uncontrolled bacterial, viral, or fungal infection requiring systemic
therapy.

- Patients with uncontrolled diabetes (requiring medication change within 30 days of
screening), or requiring insulin therapy.

- Heparin therapy.

- Known infection with HIV, hepatitis B, or hepatitis C.

- Known allergy to hyaluronidase.

- Women currently breast feeding.