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CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma
Trial Status: complete
The objective of this study is to assess the safety and efficacy of mecbotamab vedotin
(BA3011) in solid tumors.
Inclusion Criteria
Patients must have measurable disease.
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 clinically significant cardiac disease.
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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03425279.
Locations matching your search criteria
United States
Illinois
Chicago
Northwestern University
Status: Active
Name Not Available
Tennessee
Nashville
Vanderbilt University/Ingram Cancer Center
Status: Temporarily closed to accrual
Name Not Available
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
