The Pharmacokinetics and Safety of Onartuzumab (MetMAb) in Chinese Patients With Locally Advanced or Metastatic Solid Tumors

Study Overview
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Brief Summary
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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.

Official Title
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A PHASE I STUDY OF THE PHARMACOKINETICS AND SAFETY OF ONARTUZUMAB IN CHINESE PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS

Conditions
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Neoplasms

Intervention / Treatment
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* Drug: 4 mg/kg Onartuzumab (MetMAb)
* Drug: 15 mg/kg Onartuzumab (MetMAb)
* Drug: 30 mg/kg Onartuzumab (MetMAb)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4 mg/kg Onartuzumab (MetMAb)<br> | Drug: 4 mg/kg Onartuzumab (MetMAb)<br>* 4 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.<br>|
| Experimental: 15 mg/kg Onartuzumab (MetMAb)<br> | Drug: 15 mg/kg Onartuzumab (MetMAb)<br>* 15 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.<br>|
| Experimental: 30 mg/kg Onartuzumab (MetMAb)<br> | Drug: 30 mg/kg Onartuzumab (MetMAb)<br>* 30 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of anti-therapeutic antibodies against MetMAb |  | Up to 1 year |