Open-label, Multicenter, Dose Escalation Phase Ia/Ib Study With Expansion Phase to Evaluate Safety, Pharmacokinetics and Activity of RO5509554, Administered as an Intravenous Infusion as Monotherapy and in Combination With Paclitaxel in Patients With Advanced Solid Tumors.
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Histologically confirmed advanced and/or metastatic solid tumors which are not
amenable to standard therapy, with exceptions as defined in exclusion criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Measurable disease according to RECIST criteria version 1.1
- Adequate bone marrow, cardiac, liver and renal function
Exclusion Criteria:
- Known or suspected central nervous system (CNS) metastases including leptomeningeal
metastasis; patients with radiologically stable, asymptomatic previously irradiated
lesion are eligible provided patients is >/= 4 weeks beyond completing cranial
irradiation and >/= 3 weeks of corticosteroid therapy
- Significant, uncontrolled concomitant diseases, including significant cardiovascular
or pulmonary disease
- Prior chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy
for bone pain), any investigational agent or immunotherapy within 28 days of first
receipt of study drug
- Poorly controlled type 1 or type 2 diabetes
- Prior toxicities from chemotherapy or radiotherapy which have not regressed to Grade
=1 severity (NCI-CTCAE version 4.03 or later versions
- Known HIV, HBV and HCV infection
- Pulmonary embolism or any other thrombo-embolic event within 6 months prior to study
entry
- History of hematological malignancy within the last 5 years prior to study entry
- Patient requires high dose corticosteroid treatment ( i.e. > 20 mg dexamethasone a
day or equivalent for > 7 consecutive days)
- Pregnant or lactating women