CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma
NCT ID: NCT03425279
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
245 participants
INTERVENTIONAL
2018-02-15
2025-01-08
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BA3011
Phase 1: All patients will receive BA3011, CAB-AXL-ADC.
Phase 2: All patients will receive either BA3011 alone or in combination with PD-1 inhibitor.
CAB-AXL-ADC
Conditionally active biologic anti-AXL antibody drug conjugate
Combination Therapy
Phase 2: BA3011 in combination with PD-1 inhibitor.
CAB-AXL-ADC
Conditionally active biologic anti-AXL antibody drug conjugate
PD-1 inhibitor
PD-1 inhibitor
Interventions
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CAB-AXL-ADC
Conditionally active biologic anti-AXL antibody drug conjugate
PD-1 inhibitor
PD-1 inhibitor
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 12 years (Phase 2)
* Adequate renal function
* Adequate liver function
* Adequate hematological function
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of at least three months.
Exclusion Criteria
* Patients must not have known non-controlled CNS metastasis.
* Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study.
* Patients must not have had major surgery within 4 weeks before first BA3011 administration.
* Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
* Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
* Patients must not be women who are pregnant or breast feeding.
12 Years
ALL
No
Sponsors
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BioAtla, Inc.
INDUSTRY
Responsible Party
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Locations
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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 D.C., 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
St 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 City, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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Other Identifiers
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BA3011-001
Identifier Type: -
Identifier Source: org_study_id
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