CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma

Completed · Phase 1/Phase 2

Conditions studied: Undifferentiated Pleomorphic Sarcoma, Myxofibrosarcoma

In brief

The objective of this study is to assess the safety and efficacy of mecbotamab vedotin (BA3011) in solid tumors.

Key facts

Study ID

NCT03425279

Run by

BioAtla, Inc.

People needed

245

Starts

2018-02-15

Expected to finish

2025-01-08

Last updated by the study team

2025-09-23

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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