Metastases, Renal Cell Carcinoma
Conditions
Keywords
Kidney, renal, cancer, carcinoma, cell, metastatic, metastatic renal cell carcinoma, RCC
Brief summary
This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) and is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.
Interventions
DRUGVolociximab (anti-α5β1 integrin monoclonal antibody)
Volociximab intravenously (Cohort 1: 10 mg/kg every other week or Cohort 2: 15 mg/kg once a week) for up to 104 weeks or until disease progression, whichever occurs first.
Sponsors
Abbott
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females of at least 18 years of age with metastatic RCC of predominantly clear cell histology who have received 0 to 2 prior treatment regimens for metastatic disease. * Measurable disease according to Response Criteria for Solid Tumors. * Negative pregnancy test (women of childbearing potential only). * Pretreatment laboratory levels that meet specific criteria. * Signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations * Patients must have failed at least one approved or investigational tyrosine kinase inhibitor (TKI).
Exclusion criteria
* Any of the following histologies of RCC: papillary, chromophobe, collecting duct, or unclassified. * Known sensitivity to murine proteins or chimeric antibodies or other components of the product. * Use of any investigational drug within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer). * Systemic chemotherapy, immunotherapy, radiation therapy, or monoclonal antibody therapy within 4 weeks of M200 administration. * Documented central nervous system (CNS) tumor or CNS metastasis. * History of thromboembolic events and bleeding disorders within the past year. * Medical conditions that may be exacerbated by bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with a confirmed tumor response at any time during the study | Any time during the study |
Secondary
| Measure | Time frame |
|---|---|
| Time to disease progression | Up to 104 weeks |
| Duration of tumor response | Up to 104 weeks |
| Pharmacokinetics (PK) of M200 | Day 0 through Study Termination |
| Immunogenicity | Day 0 through Study Termination |
Countries
United States
Outcome results
None listed