Phase I Study of mTOR Inhibitor RAD001 in Combination With IGF-1R Inhibitor AMG479 for Patients With Advanced Solid Tumors

Inclusion Criteria:

- Histological or cytological proof of metastatic solid tumor refractory to standard
therapies, or for which no standard therapies are available.

- Patients in the expansion cohort must have a measurable site of disease according to
RECIST (v 1.0)

- Laboratory values must be obtained within protocol limits and obtained within 14 days
prior to registration

- Patients must have disease which is not amenable to potentially curative surgical
resection of metastatic disease (curative metastasectomy).

- Must be willing to provide metastatic tissue biopsy samples (may be paraffin
embedded) at baseline

- Must be willing to undergo a metastatic tissue biopsy after 2 cycles of therapy to
perform pharmacodynamic research biomarkers testing.

- Subjects must be willing and able to abstain from using strong or moderate CYP3A4
inhibitors or inducers during the study period.

Exclusion Criteria:

- No symptomatic brain metastasis

- No prior treatment with an mTOR inhibitor or with an IGF-1R inhibitor

- No known history of diabetes mellitus

- No thrombosis or vascular ischemic events within the last twelve months

- No chronic treatment with systemic steroids or another immunosuppressive agent

- No active bleeding or a pathological condition that is associated with a high risk of
bleeding

- No known history of HIV seropositivity

- No known history of Hepatitis B or Hepatitis C seropositivity

- No known hypersensitivity to AMG 479, RAD001 (everolimus), other rapamycins
(sirolimus, temsirolimus), or to its excipients

- No planned immunization with attenuated live viruses during the study period