Spots Global Cancer Trial Database for CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma
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Trial Identification
Brief Title: CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma
Official Title: A Phase 1/2 Dose Escalation and Dose Expansion Study of Mecbotamab Vedotin (BA3011) Alone and in Combination With Nivolumab in Adult and Adolescent Patients 12 Years and Older With Advanced Solid Tumors
Study ID: NCT03425279
Study Description
Brief Summary: The objective of this study is to assess the safety and efficacy of mecbotamab vedotin (BA3011) in solid tumors.
Detailed Description: This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of mecbotamab vedotin (BA3011), a conditionally active biologic (CAB) AXL-targeted antibody drug conjugate (CAB-AXL-ADC) in patients with advanced solid tumors. Phase 1 of this study will consist of a dose escalation phase (enrollment complete as of Oct 2019) and a dose expansion phase (enrollment complete as of Jan 2024). Phase 2 will consist of two parts. Part 1 is designed to evaluate mecbotamab vedotin alone and with nivolumab in patients with various types of advanced sarcomas (enrollment complete as of Jan 2024). Part 2 will evaluate the safety and efficacy of mecbotamab vedotin in patients with undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS).
Eligibility
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The University of Arizona Cancer Center, Tucson, Arizona, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
Tower Hematology Oncology Medical Group, Los Angeles, California, United States
Precision NextGen Oncology, Los Angeles, California, United States
UCSF Medical Center - Cancer Immunotherapy Clinic (CIC), San Francisco, California, United States
University of Colorado, Aurora, Colorado, United States
Sarah Cannon Research Institute at Health One, Denver, Colorado, United States
Children's Research Institute, Washington, District of Columbia, United States
Moffitt Cancer Center, Tampa, Florida, United States
Northwestern University, Chicago, Illinois, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Washington University School of Medicine - Siteman Cancer Center, Saint Louis, Missouri, United States
Comprehensive Cancer Center of Nevada, Las Vegas, Nevada, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Columbia University, New York, New York, United States
Memorial Sloan Kettering, New York, New York, United States
Duke Cancer Institute, Durham, North Carolina, United States
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
The Christ Hospital, Cincinnati, Ohio, United States
University Hospitals Seidman Cancer Center, Cleveland, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
Oregon Health & Science University, Portland, Oregon, United States
The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Abramson Cancer Center at Pennsylvania Hospital, Philadelphia, Pennsylvania, United States
Tennessee Oncology, Nashville, Tennessee, United States
Vanderbilt Ingram Cancer Center, Nashville, Tennessee, United States
Mary Crowley Cancer Research, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
University of Utah - Huntsman Cancer Institute, Salt Lake City, Utah, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Prince of Wales Hospital, Hong Kong, , Hong Kong
Queen Mary Hospital, Hong Kong, , Hong Kong
National Cheng Kung University Hospital, Tainan, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital, Taoyuan, , Taiwan
Contact Details
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