An Open-label, Multi-center, Dose Escalation Phase I Study of Single Agent RO5520985, Administered as an Intravenous Infusion in Patients With Locally Advanced or Metastatic Solid Tumors.
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Patients with histologically or cytologically confirmed locally advanced or
metastatic, non-resectable solid tumors whose disease has progressed despite standard
therapy or for whom no standard therapy exists
- Measurable disease as determined by RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate hematological function
- Adequate liver function
- Adequate renal function
- Adequate coagulation
- Adequate cardiovascular function
- Recovery from all reversible adverse events of previous anti-cancer therapies to
baseline or CTCAE G 1, except for alopecia (any grade) and < or = G 2 sensory
peripheral neuropathy
Exclusion Criteria:
- Patients with primary CNS tumors or CNS tumor involvement. Patients with metastatic
CNS tumors may participate in this trial under conditions defined by protocol
- Patients with squamous non-small cell lung cancer histology
- Prior treatment with anti-angiogenic agents targeting VEGF/Ang-1/Ang-2/PIGF and its
receptors within 6 months prior to study drug administration
- Prior systemic anti-cancer therapy within the following timeframes: a) cyclical
chemotherapy within a period of time that is shorter than the cycle length for the
treatment used prior to study drug administration; b) biologic therapy or continuous
or intermittent treatment with small molecule therapeutics (targeted therapies)
within 4 weeks or < or = 5 half-lives of the drug concerned (whichever is shorter)
prior to study drug administration
- Treatment with any other investigational agents within less than the cycle length
used for that treatment or within 4 weeks (whichever is shorter) prior to study drug
administration
- Major surgery within 4 weeks prior to study drug administration
- Significant cardiovascular/cerebrovascular disease within 6 months prior to study
drug administration
- Known HIV infection or known active hepatitis B or hepatitis C virus infection
- Pregnant or nursing women