What is the Purpose of this Study?
The purpose of this study is to determine whether an experimental drug called CRB-601 can help people with advanced solid tumors (cancer). The study aims to evaluate how well the drug is tolerated and identify the highest dose of CRB-601 that can be given when used as monotherapy (by itself). Researchers also want to understand the effectiveness of CRB-601 in controlling symptoms of cancer and whether it can decrease the size of the patient’s tumor. The study will evaluate how CRB-601 is absorbed, metabolized (chemically broken down), distributed, and removed from the body. Procedures include receiving CRB-60 intravenously (through IV), blood and urine sample collection, physical exams, electrocardiograms, fresh biopsy, and computed tomography/magnetic resonance imaging. CRB-601 is in a drug class known as “monoclonal antibodies.” Monoclonal antibodies are made in a laboratory and act to simulate the body’s ability to fight off harmful foreign materials and treat diseases like cancer.
Eligibility
- * Confirmed diagnosis of select locally advanced or metastatic solid tumors that have progressed after at least one line of therapy or have no other standard therapy with proven clinical benefit available.
- * Measurable disease on imaging as assessed by RECIST 1.1 Eastern Cooperative Oncology Group (ECOG) performance status (PS) greater or equal to 2.
- * Life expectancy of more than 12 weeks.
- * Adequate hematologic and end-organ function.
Where can I participate?
- CS Cancer at Cedars-Sinai Medical Center : Shannon Cyhan
- CS Cancer at The Angeles Clinic and Research Institute : Shannon Cyhan
More about this Clinical Trial
What is the full name of this clinical trial?
CRB-601-01: A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics and Efficacy of CRB-601, a Monoclonal Antibody against Integrin av B8, in Patients with Advanced Solid Tumors