A Phase I Multiple Ascending Dose (MAD) Study of RO5458640, a Humanized Monoclonal Antibody Against the TNF-like Weak Inducer of Apoptosis (TWEAK) Ligand, in Patients With Advanced Solid Tumors
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Histologically or cytologically confirmed malignant solid tumors
- Measurable and/or evaluable disease according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate bone marrow, liver and renal function
Exclusion Criteria:
- Prior chemotherapy, radiotherapy, or hormonal therapy for cancer within 3 weeks of
first study treatment, except for short course palliative radiotherapy for pain
- Antibody therapy or other immunotherapy currently or less than 21 days prior to study
treatment
- Current immunosuppressive therapy, including those prescribed for organ
transplantation and rheumatologic disease
- Corticoid therapy > 10 mg/day prednisone or equivalent
- Patients who have not recovered from > grade 1 (NCI CTCAE) prior adverse events from
any cancer therapy, except for alopecia
- Pregnant or breastfeeding women
- Known hypersensitivity to any component of RO5458640 or previous severe
hypersensitivity reactions to monoclonal antibody therapy
- History of active seizure disorder
- History of CNS or leptomeningeal metastases, except for clinically stable disease for
at least 3 weeks prior to first study drug
- Cardiovascular illness: CVA or MI < 6 months prior to study, CHF > NYHA Class 2, QTcF
>480 msec.
- Active infection