Study of M200 (Volociximab) in Patients With Metastatic Renal Cell Carcinoma (RCC)

Study Overview
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Brief Summary
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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.

Official Title
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Phase 2 Open-Label Study of Volociximab (M200) in Patients With Metastatic Renal Cell Carcinoma

Conditions
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Renal Cell Carcinoma, Metastases

Intervention / Treatment
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* Drug: Volociximab (anti-α5β1 integrin monoclonal antibody)


Participation Criteria
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Eligibility Criteria
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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.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Volociximab administered intravenously at a dose of 10 mg/kg qowk | Drug: Volociximab (anti-α5β1 integrin monoclonal antibody)<br>* 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.<br>|
| Experimental: Arm 2<br>Volociximab administered intravenously at a dose of 15 mg/kg qwk | Drug: Volociximab (anti-α5β1 integrin monoclonal antibody)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with a confirmed tumor response at any time during the study |  | Any time during the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney, renal, cancer, carcinoma, cell, metastatic, metastatic renal cell carcinoma, RCC