Clinical trial · Interventional
The Pharmacokinetics and Safety of Onartuzumab (MetMAb) in Chinese Patients With Locally Advanced or Metastatic Solid Tumors
A PHASE I STUDY OF THE PHARMACOKINETICS AND SAFETY OF ONARTUZUMAB IN CHINESE PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 15 mg/kg Onartuzumab (MetMAb) | Drug | Onartuzumab | ALIAS |
| 30 mg/kg Onartuzumab (MetMAb) | Drug | Onartuzumab | ALIAS |
| 4 mg/kg Onartuzumab (MetMAb) | Drug | Onartuzumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 4 mg/kg Onartuzumab (MetMAb)
- interventionNames
- Drug: 4 mg/kg Onartuzumab (MetMAb)
- type
- EXPERIMENTAL
- label
- 15 mg/kg Onartuzumab (MetMAb)
- interventionNames
- Drug: 15 mg/kg Onartuzumab (MetMAb)
- type
- EXPERIMENTAL
- label
- 30 mg/kg Onartuzumab (MetMAb)
- interventionNames
- Drug: 30 mg/kg Onartuzumab (MetMAb)
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available