Neoplasms
Conditions
Brief summary
This phase I study will examine the pharmacokinetics and safety of Onartuzumab (MetMAb) in chinese patients with locally advanced or metastatic solid tumors. Patients will be divided into 3 cohorts, which will each be given a different dose of MetMAb. The cohorts will be treated sequentially, starting with the lowest dose. MetMAb will be administered intravenously every 3 weeks. Patients may be treated for up to 16 cycles (21 days each) or 1 year, whichever occurs first, in the absence of disease progression.
Interventions
DRUG4 mg/kg Onartuzumab (MetMAb)
4 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.
DRUG15 mg/kg Onartuzumab (MetMAb)
15 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.
DRUG30 mg/kg Onartuzumab (MetMAb)
30 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>/= 18 years * Histologically confirmed locally advanced or metastatic solid tumor that does not respond to standard treatment or for which there is no further standard treatment. * Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2. * Use of effective contraception * Life expectancy \> 3 months
Exclusion criteria
* Brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation, and/or patients with brain metastasis that have been receiving corticosteroids. * Previously diagnosed and treated central nervous system (CNS) metastases or spinal cord compression that has not been clinically stable for at least 2 months. * Treatment with anti-tumor therapy within 4 weeks before the start of study treatment, with the following exception: Patients with metastatic prostate cancer on maintenance hormonal therapy, provided they meet all other eligibility criteria. * Current, serious or uncontrolled, systemic illness. * Recent stroke (within the past 6 months). * Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs (NSAIDs). * History of cardiovascular conditions. * Any other disease, gastrointestinal abnormality, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications. * Receipt of any investigational agent, or participation in any other clinical study, within 4 weeks before the start of study treatment. * Major surgery within 4 weeks before the start of study treatment, without complete recovery. * Significant traumatic injury within 3 weeks before the start of study treatment (All wounds must be fully healed prior to Day 1). * Uncontrolled excess calcium levels. * Known human immunodeficiency virus (HIV) infection. * Inadequate organ function * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | Up to 1 year |
| Total exposure of MetMAb, as measured by area under the concentration-time curve (AUC) | Up to 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of anti-therapeutic antibodies against MetMAb | Up to 1 year |
Countries
China
Outcome results
None listed